ObesityBYPSADISNCT06789965
Comparison of Two Surgical Techniques for Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodenoileal Bypass With Sleeve Gastrectomy and Roux-en-Y Gastric Bypass.
A study testing SADI-S and RY-GBP in people with Obesity, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Roux-en-Y gastric bypass (RY-GBP) is one of the surgical techniques most widely used for the treatment of obesity. Long series of operated patients published in the literature have demonstrated its safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- SADI-S and RY-GBP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 1 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 40 - 50 Kg/m2
- Candidates to mixed bariatric surgery
Who cannot join
- < 18 years.
- > 60 years.
- BMI < 40 Kg/m2
- BMI > 50 Kg/m2.
- Non-candidates to mixed bariatric surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic Barcelona
Barcelona, Barcelona, 08036
Javier Osorio-Aguilar, PhD, +34932275400 ext. 5718, josorio@clinic.cat
About this study
Official title: Randomized Clinical Trial Comparing Two Surgical Techniques for the Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S) and Roux-en-Y Gastric Bypass (RY-GBP)
Roux-en-Y gastric bypass (RY-GBP) is one of the surgical techniques most widely used for the treatment of obesity. Long series of operated patients published in the literature have demonstrated its safety and efficacy. It consists on the reduction of the size of the stomach and joining it (anastomosis) with the small bowel to reduce the absorption of calories.
Single anastomosis duodenoileal with sleeve gastrectomy is an increasingly used surgical technique that is a simplification of the duodenal switch. It consists on the reduction of the stomach to a tube (sleeve gastrectomy) and an anastomosis between the duodenum and the small bowel. It has been demonstrated as a effective technique and it is supported by the international scientific societies.
There are no data that indicate a superiority of one technique over the other. The objective of this study is to analyze if there are differences between the two techniques in terms of postoperative weight control and gastroesophageal reflux at short, medium and long term.
Read the detailed description
Obesity is being considered an epidemic of our century. It directly or indirectly contributes as the leading cause of non-traumatic death in the Western population and is progressively reaching developing countries as well. In Spain, recent epidemiological studies estimate that over 15% of the population is at least overweight, and nearly 5% has morbid obesity. The treatment of obesity is multidisciplinary, ranging from lifestyle and dietary changes to surgery. Among all available treatments, the only truly cost-effective option for patients with morbid obesity is bariatric surgery. The beneficial effects go far beyond weight loss, as it has been shown to reduce and improve comorbidities, enhance quality of life, lower cardiovascular risk, and even reduce mortality in individuals affected by obesity.
Duodenal switch (DS) has proven to be the most effective surgical procedure for treating morbid obesity and its comorbidities. However, it currently represents a small percentage of bariatric surgeries performed worldwide, likely due to its technical complexity and the risk of long-term complications. In an effort to simplify the DS technique, in 2007, Drs. Sánchez-Pernaute and Torres introduced the Single Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S). The omega reconstruction, which avoids the distal ileo-ileal anastomosis, aims to decrease surgical time and reduce postoperative risks. The SADI-S involves a vertical gastrectomy (VG) and a duodeno-ileal anastomosis with preservation of the pylorus, jejunal exclusion, and an original total common channel of 200 cm, standardized later to 250 or 300 cm to minimize the risk of nutritional deficiencies. The SADI-S can be performed as a primary direct surgery, planned in two stages, or as a revisional surgery in case of weight loss failure after VG. Various prospective studies presented on SADI-S show weight loss results and reduction of comorbidities similar to those of large historical series of DS.
The Roux-en-Y gastric bypass (RY-GBP) is currently considered the gold standard of bariatric surgery. It involves creating a small gastric reservoir and a Roux-en-Y gastrojejunostomy.
his is a well-standardized technique with large cohorts of patients followed over the long term, which has demonstrated safety and efficacy in weight control, resolution of metabolic comorbidities, as well as improvement in life expectancy and quality of life. Furthermore, it is the best technique for preventing or treating gastroesophageal reflux (GERD), due to its small gastric reservoir and rapid emptying. However, it has potential specific complications resulting from the non-preservation of the pylorus and mesenteric partitioning: anastomotic ulcer, early or late dumping syndrome, hypoglycemia, and abdominal pain associated with internal hernias. All of these complications are rare but much more frequent after an RY-GBP than after a SADI-S.
Currently, there is only one ongoing study comparing the efficacy and safety of SADI-S with RY-GBP. This is SADISLEEVE (ClinicalTrials.gov ID NCT03610256), a French multicenter randomized study that has several methodological limitations in its design: it includes both patients undergoing primary and revisional surgery, without BMI restrictions and with varying lengths of limbs.
The present prospective randomized study aims to compare SADI-S with RY-GBP. It includes patients with a BMI between 40 and 50 kg/m² for whom gastric bypass would be indicated at the participating centers. Patients who do not meet the requirements for bariatric surgery, as well as those with contraindications for hypoabsorptive or mixed surgery, are excluded.
The project has two objectives: a) efficacy: to compare the percentage of weight lost at 2 and 5 years after the two surgical procedures; b) safety: to assess the percentage of serious complications at 2 and 5 years. Routine follow-up controls from both Endocrinology and Dietetics, as well as General Surgery, will be used for both.
The most relevant secondary objective is to compare quality of life, for which SF-12 questionnaires will be systematically administered, along with the most likely factors affecting it: resolution of comorbidities, symptoms of GERD, abdominal pain, dumping syndrome, hypoglycemia, diarrhea, and need for supplementation. Gastroscopy and esophageal pH-impedance measurement will also be performed before the operation and at 2 and 5 years post-surgery.
Other secondary objectives include comparing short-term complications and studying nutritional and metabolic deficits of both procedures in the medium and long term. For the study of morbidity and mortality, the electronic medical records of the patients will be used, classifying immediate postoperative events (up to 30 days post-intervention) according to the Clavien-Dindo classification. The analysis of comorbidity evolution will involve monitoring factors related to metabolic risk in these patients before the intervention and annually thereafter, utilizing the infrastructure of the patient follow-up protocol. Finally, the analysis of metabolic and nutritional deficits will be conducted through comparative analysis of the annual analytical data systematically collected during the follow-up of the intervened patients.
Main Hypothesis: The Single Anastomosis Duodeno-Ileal bypass (SADI-S) is associated with greater efficacy (higher percentage of weight loss) and similar safety (equal or lower percentage of serious complications) at two and five years post-surgery compared to gastric bypass (RY-GBP) in patients with grade III morbid obesity (BMI between 40 and 50 kg/m²).
Secondary Hypotheses:
- SADI-S is associated with lower incidence of digestive symptoms: dumping syndrome, hypoglycemia, and abdominal pain.
- SADI-S is associated with better quality of life than RY-GBP.
- RY-GBP is associated with a lower risk of GERD and a higher risk of anastomotic ulcer.
- The complication rates of both techniques in the immediate postoperative period (up to 30 days post-intervention) are similar.
- SADI-S achieves higher rates of resolution of metabolic syndrome comorbidities: type 2 diabetes mellitus (T2DM), hypertension (HT), dyslipidemia (DL), and sleep apnea (SA).
- Patients undergoing SADI-S and RY-GBP require similar supplementation to compensate for nutritional deficits in the short, medium, and long term.
- Baseline eating habits are related to weight loss at 2 and 5 years within each of the two patient groups.
- Differences in acid and bile reflux occur between the two techniques, which can be objectively measured with functional tests such as pH-metry, impedance measurement, and bilitec.
- Conditions
- Obesity
- Being tested
- SADI-S, RY-GBP
- Keywords
- obesity, sadi-s, ry-gbp, weight loss, metabolic complications, sadis, gbp, rygbp, bariatric surgery
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SADI-SProcedure or surgery
In the case of SADI-S, the complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of s
RY-GBPProcedure or surgery
In the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| SADI-S | Experimental | The complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of special technical diff Receives: Procedure: SADI-S |
| RY-GBP | Active comparator | In the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications. Receives: Procedure: RY-GBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with Total weight loss at 2 years > 30%
% of patients with Total weight loss at 2 years > 30%
Measured: 2 years after intervention
% of patients with Total weight loss at 5 years > 30%
% of patients with Total weight loss at 5 years > 30%
Measured: 5 years after intervention
Short term postoperative complications
Complications classified as Clavien-Dindo III or IV (requiring reintervention, endoscopic or radioguided interventional treatment, or admission to the ICU).
Measured: From intervention to the end of the short term at 30 days after surgery.
Middle to long-term postoperative complications
In the medium to long term, any complication that requires reintervention, endoscopic or radioguided interventional treatment, ICU admission, maintained parenteral or enteral nutrition, or specific parenteral treatment is included. This encompasses complications attributable to bariatric surgery, such as intestinal obstruction, internal hernia, diarrhea, hypoglycemia, dumping syndrome, malnutrition, ulcer, and GERD. Reintervention due to incisional hernia, cholecystectomy, or causes unrelated to bariatric surgery is excluded.
Measured: From 30 days after intervention to the end of the study 5 years after the intervention.
Secondary outcomes (9)
Digestive symptoms at 2 years after surgery
Prevalence of digestive symptoms (dumping syndrome, hypoglycemia, GERD, bowel habits, and abdominal pain) at 2 years measured using the following scales: ARTS for dumping syndrome, GERD Q for gastroesophageal reflux disease, Bristol and Wexner scales for bowel habits, QoL SF-12 for abdominal pain)
Measured: From the intervention up to 2 years after surgery
Digestive symptoms at 5 years after surgery
Prevalence of digestive symptoms (dumping syndrome, hypoglycemia, GERD, bowel habits, and abdominal pain) at 5 years measured using the following scales: ARTS for dumping syndrome, GERD Q for gastroesophageal reflux disease, Bristol and Wexner scales for bowel habits, QoL SF-12 for abdominal pain)
Measured: From the 2nd year until the end of the follow-up 5 years after the intervention.
Endoscopic findings at 2 years
Prevalence of endoscopic findings(esophagitis, ulcer, gastritis, bile lakes) at 2 years
Measured: From the intervention up to 2 years after surgery
Postoperative morbidity and mortality
Postoperative morbidity and mortality (30 and 90 days after surgery)
Measured: From the intervention up to 90 days after surgery
Resolution of metabolic comorbidities at 2 years
Resolution of metabolic comorbidities (T2DM, hypertension, dyslipidemia, and sleep apnea) at 2 years.
Measured: From the intervention up to 2 years after surgery
Resolution of metabolic comorbidities at 5 years
Resolution of metabolic comorbidities (T2DM, hypertension, dyslipidemia, and sleep apnea) at 5 years
Measured: 5 years after intervention
Quality of life
Difference on the total puntuation of the quality of life scales SF-12 at 2 and 5 years measured using the QoL scale SF-12.
Measured: From the intervention to the end of the study 5 years after the intervention.
Metabolic and nutritional deficits at 2 and 5 years
Prevalence of metabolic and nutritional deficits at 2 and 5 years measured using BARSCORE
Measured: From the intervention to the end of the follow-up at 5 years after surgery.
Eating habits
Difference in the total count of the Dutch Behaviour Questionnaire of eating habits before the intervention, at 2 years and 5 years after surgery measured using the Dutch Behaviour Questionnaire.
Measured: Before the intervention up to 5 years after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Feb 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Osorio, PhD, Principal investigator, General & Digestive Surgery Department, ICMDM, Clinic Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789965
- Sponsor's protocol ID
- HCB/2024/0752
- Acronym
- BYPSADIS
- Status last verified
- Apr 2025
- First submitted
- 16 Dec 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon request to the principal investigator.
Publications
Arts J, Caenepeel P, Bisschops R, Dewulf D, Holvoet L, Piessevaux H, Bourgeois S, Sifrim D, Janssens J, Tack J. Efficacy of the long-acting repeatable formulation of the somatostatin analogue octreotide in postoperative dumping. Clin Gastroenterol Hepatol. 2009 Apr;7(4):432-7. doi: 10.1016/j.cgh.2008.11.025. Epub 2008 Dec 13.
PubMed 19264574Scarpellini E, Arts J, Karamanolis G, Laurenius A, Siquini W, Suzuki H, Ukleja A, Van Beek A, Vanuytsel T, Bor S, Ceppa E, Di Lorenzo C, Emous M, Hammer H, Hellstrom P, Laville M, Lundell L, Masclee A, Ritz P, Tack J. International consensus on the diagnosis and management of dumping syndrome. Nat Rev Endocrinol. 2020 Aug;16(8):448-466. doi: 10.1038/s41574-020-0357-5. Epub 2020 May 26.
PubMed 32457534Clapp B, Hahn J, Dodoo C, Guerra A, de la Rosa E, Tyroch A. Evaluation of the rate of marginal ulcer formation after bariatric surgery using the MBSAQIP database. Surg Endosc. 2019 Jun;33(6):1890-1897. doi: 10.1007/s00464-018-6468-6. Epub 2018 Sep 24.
PubMed 30251139Nandipati KC, Bremer KC. Bariatric Surgery Emergencies in Acute Care Surgery. Surg Clin North Am. 2023 Dec;103(6):1113-1131. doi: 10.1016/j.suc.2023.05.013. Epub 2023 Jul 1.
PubMed 37838459van Beek AP, Emous M, Laville M, Tack J. Dumping syndrome after esophageal, gastric or bariatric surgery: pathophysiology, diagnosis, and management. Obes Rev. 2017 Jan;18(1):68-85. doi: 10.1111/obr.12467. Epub 2016 Oct 17.
PubMed 27749997Pletch A, Lidor A. GERD after Bariatric Surgery: A Review of the Underlying Causes and Recommendations for Management. Curr Gastroenterol Rep. 2024 Apr;26(4):99-106. doi: 10.1007/s11894-024-00919-7. Epub 2024 Feb 14.
PubMed 38353898Olbers T, Beamish AJ, Gronowitz E, Flodmark CE, Dahlgren J, Bruze G, Ekbom K, Friberg P, Gothberg G, Jarvholm K, Karlsson J, Marild S, Neovius M, Peltonen M, Marcus C. Laparoscopic Roux-en-Y gastric bypass in adolescents with severe obesity (AMOS): a prospective, 5-year, Swedish nationwide study. Lancet Diabetes Endocrinol. 2017 Mar;5(3):174-183. doi: 10.1016/S2213-8587(16)30424-7. Epub 2017 Jan 6.
PubMed 28065734Syn NL, Cummings DE, Wang LZ, Lin DJ, Zhao JJ, Loh M, Koh ZJ, Chew CA, Loo YE, Tai BC, Kim G, So JB, Kaplan LM, Dixon JB, Shabbir A. Association of metabolic-bariatric surgery with long-term survival in adults with and without diabetes: a one-stage meta-analysis of matched cohort and prospective controlled studies with 174 772 participants. Lancet. 2021 May 15;397(10287):1830-1841. doi: 10.1016/S0140-6736(21)00591-2. Epub 2021 May 6.
PubMed 33965067Gronroos S, Helmio M, Juuti A, Tiusanen R, Hurme S, Loyttyniemi E, Ovaska J, Leivonen M, Peromaa-Haavisto P, Maklin S, Sintonen H, Sammalkorpi H, Nuutila P, Salminen P. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):137-146. doi: 10.1001/jamasurg.2020.5666.
PubMed 33295955Angrisani L, Santonicola A, Iovino P, Ramos A, Shikora S, Kow L. Bariatric Surgery Survey 2018: Similarities and Disparities Among the 5 IFSO Chapters. Obes Surg. 2021 May;31(5):1937-1948. doi: 10.1007/s11695-020-05207-7. Epub 2021 Jan 12.
PubMed 33432483Salminen P, Gronroos S, Helmio M, Hurme S, Juuti A, Juusela R, Peromaa-Haavisto P, Leivonen M, Nuutila P, Ovaska J. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2022 Aug 1;157(8):656-666. doi: 10.1001/jamasurg.2022.2229.
PubMed 35731535Lind RP, Ghanem M, Teixeira AF, Jawad MA, Osorio J, Lazzara C, Sobrino L, Ortiz-Ciruela D, de Gordejuela AGR. Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. Obes Surg. 2022 Dec;32(12):3869-3878. doi: 10.1007/s11695-022-06315-2. Epub 2022 Oct 24.
PubMed 36279044Osorio J, Lazzara C, Admella V, Franci-Leon S, Pujol-Gebelli J. Revisional Laparoscopic SADI-S vs. Duodenal Switch Following Failed Primary Sleeve Gastrectomy: a Single-Center Comparison of 101 Consecutive Cases. Obes Surg. 2021 Aug;31(8):3667-3674. doi: 10.1007/s11695-021-05469-9. Epub 2021 May 12.
PubMed 33982240Finno P, Osorio J, Garcia-Ruiz-de-Gordejuela A, Casajoana A, Sorribas M, Admella V, Serrano M, Marchesini JB, Ramos AC, Pujol-Gebelli J. Single Versus Double-Anastomosis Duodenal Switch: Single-Site Comparative Cohort Study in 440 Consecutive Patients. Obes Surg. 2020 Sep;30(9):3309-3316. doi: 10.1007/s11695-020-04566-5.
PubMed 32240495Hess DS, Hess DW. Biliopancreatic diversion with a duodenal switch. Obes Surg. 1998 Jun;8(3):267-82. doi: 10.1381/096089298765554476.
PubMed 9678194
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Two Surgical Techniques for the Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S) and Roux-en-Y Gastric Bypass (RY-GBP)
- ClinicalTrials.gov ID
- NCT06789965
- Acronym / sponsor ID
- BYPSADIS / HCB/2024/0752
- Conditions
- Obesity
- Keywords
- obesity, sadi-s, ry-gbp, weight loss, metabolic complications, sadis, gbp, rygbp
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Roux-en-Y gastric bypass (RY-GBP) is one of the surgical techniques most widely used for the treatment of obesity. Long series of operated patients published in the literature have demonstrated its safety and efficacy. It consists on the reduction of the size of the stomach and joining it (anastomosis) with the small bowel to reduce the absorption of calories.
Single anastomosis duodenoileal with sleeve gastrectomy is an increasingly used surgical technique that is a simplification of the duodenal switch. It consists on the reduction of the stomach to a tube (sleeve gastrectomy) and an anastomosis between the duodenum and the small bowel. It has been demonstrated as a effective technique and it is supported by the international scientific societies.
There are no data that indicate a superiority of one technique over the other. The objective of this study is to analyze if there are differences between the two techniques in terms of postoperative weight control and gastroesophageal reflux at short, medium and long term.
Detailed description
Obesity is being considered an epidemic of our century. It directly or indirectly contributes as the leading cause of non-traumatic death in the Western population and is progressively reaching developing countries as well. In Spain, recent epidemiological studies estimate that over 15% of the population is at least overweight, and nearly 5% has morbid obesity. The treatment of obesity is multidisciplinary, ranging from lifestyle and dietary changes to surgery. Among all available treatments, the only truly cost-effective option for patients with morbid obesity is bariatric surgery. The beneficial effects go far beyond weight loss, as it has been shown to reduce and improve comorbidities, enhance quality of life, lower cardiovascular risk, and even reduce mortality in individuals affected by obesity.
Duodenal switch (DS) has proven to be the most effective surgical procedure for treating morbid obesity and its comorbidities. However, it currently represents a small percentage of bariatric surgeries performed worldwide, likely due to its technical complexity and the risk of long-term complications. In an effort to simplify the DS technique, in 2007, Drs. Sánchez-Pernaute and Torres introduced the Single Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S). The omega reconstruction, which avoids the distal ileo-ileal anastomosis, aims to decrease surgical time and reduce postoperative risks. The SADI-S involves a vertical gastrectomy (VG) and a duodeno-ileal anastomosis with preservation of the pylorus, jejunal exclusion, and an original total common channel of 200 cm, standardized later to 250 or 300 cm to minimize the risk of nutritional deficiencies. The SADI-S can be performed as a primary direct surgery, planned in two stages, or as a revisional surgery in case of weight loss failure after VG. Various prospective studies presented on SADI-S show weight loss results and reduction of comorbidities similar to those of large historical series of DS.
The Roux-en-Y gastric bypass (RY-GBP) is currently considered the gold standard of bariatric surgery. It involves creating a small gastric reservoir and a Roux-en-Y gastrojejunostomy.
his is a well-standardized technique with large cohorts of patients followed over the long term, which has demonstrated safety and efficacy in weight control, resolution of metabolic comorbidities, as well as improvement in life expectancy and quality of life. Furthermore, it is the best technique for preventing or treating gastroesophageal reflux (GERD), due to its small gastric reservoir and rapid emptying. However, it has potential specific complications resulting from the non-preservation of the pylorus and mesenteric partitioning: anastomotic ulcer, early or late dumping syndrome, hypoglycemia, and abdominal pain associated with internal hernias. All of these complications are rare but much more frequent after an RY-GBP than after a SADI-S.
Currently, there is only one ongoing study comparing the efficacy and safety of SADI-S with RY-GBP. This is SADISLEEVE (ClinicalTrials.gov ID NCT03610256), a French multicenter randomized study that has several methodological limitations in its design: it includes both patients undergoing primary and revisional surgery, without BMI restrictions and with varying lengths of limbs.
The present prospective randomized study aims to compare SADI-S with RY-GBP. It includes patients with a BMI between 40 and 50 kg/m² for whom gastric bypass would be indicated at the participating centers. Patients who do not meet the requirements for bariatric surgery, as well as those with contraindications for hypoabsorptive or mixed surgery, are excluded.
The project has two objectives: a) efficacy: to compare the percentage of weight lost at 2 and 5 years after the two surgical procedures; b) safety: to assess the percentage of serious complications at 2 and 5 years. Routine follow-up controls from both Endocrinology and Dietetics, as well as General Surgery, will be used for both.
The most relevant secondary objective is to compare quality of life, for which SF-12 questionnaires will be systematically administered, along with the most likely factors affecting it: resolution of comorbidities, symptoms of GERD, abdominal pain, dumping syndrome, hypoglycemia, diarrhea, and need for supplementation. Gastroscopy and esophageal pH-impedance measurement will also be performed before the operation and at 2 and 5 years post-surgery.
Other secondary objectives include comparing short-term complications and studying nutritional and metabolic deficits of both procedures in the medium and long term. For the study of morbidity and mortality, the electronic medical records of the patients will be used, classifying immediate postoperative events (up to 30 days post-intervention) according to the Clavien-Dindo classification. The analysis of comorbidity evolution will involve monitoring factors related to metabolic risk in these patients before the intervention and annually thereafter, utilizing the infrastructure of the patient follow-up protocol. Finally, the analysis of metabolic and nutritional deficits will be conducted through comparative analysis of the annual analytical data systematically collected during the follow-up of the intervened patients.
Main Hypothesis: The Single Anastomosis Duodeno-Ileal bypass (SADI-S) is associated with greater efficacy (higher percentage of weight loss) and similar safety (equal or lower percentage of serious complications) at two and five years post-surgery compared to gastric bypass (RY-GBP) in patients with grade III morbid obesity (BMI between 40 and 50 kg/m²).
Secondary Hypotheses:
- SADI-S is associated with lower incidence of digestive symptoms: dumping syndrome, hypoglycemia, and abdominal pain.
- SADI-S is associated with better quality of life than RY-GBP.
- RY-GBP is associated with a lower risk of GERD and a higher risk of anastomotic ulcer.
- The complication rates of both techniques in the immediate postoperative period (up to 30 days post-intervention) are similar.
- SADI-S achieves higher rates of resolution of metabolic syndrome comorbidities: type 2 diabetes mellitus (T2DM), hypertension (HT), dyslipidemia (DL), and sleep apnea (SA).
- Patients undergoing SADI-S and RY-GBP require similar supplementation to compensate for nutritional deficits in the short, medium, and long term.
- Baseline eating habits are related to weight loss at 2 and 5 years within each of the two patient groups.
- Differences in acid and bile reflux occur between the two techniques, which can be objectively measured with functional tests such as pH-metry, impedance measurement, and bilitec.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SADI-S | Experimental | Procedure: SADI-SThe complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of special technical diff |
| RY-GBP | Active comparator | Procedure: RY-GBPIn the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 40 - 50 Kg/m2
- Candidates to mixed bariatric surgery
Key exclusion criteria (5 listed)
- < 18 years.
- > 60 years.
- BMI < 40 Kg/m2
- BMI > 50 Kg/m2.
- Non-candidates to mixed bariatric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SADI-SIn the case of SADI-S, the complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of s | Procedure or surgery | SADI-S |
| RY-GBPIn the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications. | Procedure or surgery | RY-GBP |
Primary outcome
% of patients with Total weight loss at 2 years > 30%
Time frame: 2 years after intervention
% of patients with Total weight loss at 2 years > 30%
% of patients with Total weight loss at 5 years > 30%
Time frame: 5 years after intervention
% of patients with Total weight loss at 5 years > 30%
Short term postoperative complications
Time frame: From intervention to the end of the short term at 30 days after surgery.
Complications classified as Clavien-Dindo III or IV (requiring reintervention, endoscopic or radioguided interventional treatment, or admission to the ICU).
Middle to long-term postoperative complications
Time frame: From 30 days after intervention to the end of the study 5 years after the intervention.
In the medium to long term, any complication that requires reintervention, endoscopic or radioguided interventional treatment, ICU admission, maintained parenteral or enteral nutrition, or specific parenteral treatment is included. This encompasses complications attributable to bariatric surgery, such as intestinal obstruction, internal hernia, diarrhea, hypoglycemia, dumping syndrome, malnutrition, ulcer, and GERD. Reintervention due to incisional hernia, cholecystectomy, or causes unrelated to bariatric surgery is excluded.
9 secondary outcomes
Digestive symptoms at 2 years after surgery
Time frame: From the intervention up to 2 years after surgery
Digestive symptoms at 5 years after surgery
Time frame: From the 2nd year until the end of the follow-up 5 years after the intervention.
Endoscopic findings at 2 years
Time frame: From the intervention up to 2 years after surgery
Postoperative morbidity and mortality
Time frame: From the intervention up to 90 days after surgery
Resolution of metabolic comorbidities at 2 years
Time frame: From the intervention up to 2 years after surgery
Resolution of metabolic comorbidities at 5 years
Time frame: 5 years after intervention
Quality of life
Time frame: From the intervention to the end of the study 5 years after the intervention.
Metabolic and nutritional deficits at 2 and 5 years
Time frame: From the intervention to the end of the follow-up at 5 years after surgery.
Eating habits
Time frame: Before the intervention up to 5 years after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 19264574Arts J, Caenepeel P, Bisschops R, Dewulf D, Holvoet L, Piessevaux H, Bourgeois S, Sifrim D, Janssens J, Tack J. Efficacy of the long-acting repeatable formulation of the somatostatin analogue octreotide in postoperative dumping. Clin Gastroenterol Hepatol. 2009 Apr;7(4):432-7. doi: 10.1016/j.cgh.2008.11.025. Epub 2008 Dec 13.
- Background: PubMed 32457534Scarpellini E, Arts J, Karamanolis G, Laurenius A, Siquini W, Suzuki H, Ukleja A, Van Beek A, Vanuytsel T, Bor S, Ceppa E, Di Lorenzo C, Emous M, Hammer H, Hellstrom P, Laville M, Lundell L, Masclee A, Ritz P, Tack J. International consensus on the diagnosis and management of dumping syndrome. Nat Rev Endocrinol. 2020 Aug;16(8):448-466. doi: 10.1038/s41574-020-0357-5. Epub 2020 May 26.
- Background: PubMed 30251139Clapp B, Hahn J, Dodoo C, Guerra A, de la Rosa E, Tyroch A. Evaluation of the rate of marginal ulcer formation after bariatric surgery using the MBSAQIP database. Surg Endosc. 2019 Jun;33(6):1890-1897. doi: 10.1007/s00464-018-6468-6. Epub 2018 Sep 24.
- Background: PubMed 37838459Nandipati KC, Bremer KC. Bariatric Surgery Emergencies in Acute Care Surgery. Surg Clin North Am. 2023 Dec;103(6):1113-1131. doi: 10.1016/j.suc.2023.05.013. Epub 2023 Jul 1.
- Background: PubMed 27749997van Beek AP, Emous M, Laville M, Tack J. Dumping syndrome after esophageal, gastric or bariatric surgery: pathophysiology, diagnosis, and management. Obes Rev. 2017 Jan;18(1):68-85. doi: 10.1111/obr.12467. Epub 2016 Oct 17.
- Background: PubMed 38353898Pletch A, Lidor A. GERD after Bariatric Surgery: A Review of the Underlying Causes and Recommendations for Management. Curr Gastroenterol Rep. 2024 Apr;26(4):99-106. doi: 10.1007/s11894-024-00919-7. Epub 2024 Feb 14.
- Background: PubMed 28065734Olbers T, Beamish AJ, Gronowitz E, Flodmark CE, Dahlgren J, Bruze G, Ekbom K, Friberg P, Gothberg G, Jarvholm K, Karlsson J, Marild S, Neovius M, Peltonen M, Marcus C. Laparoscopic Roux-en-Y gastric bypass in adolescents with severe obesity (AMOS): a prospective, 5-year, Swedish nationwide study. Lancet Diabetes Endocrinol. 2017 Mar;5(3):174-183. doi: 10.1016/S2213-8587(16)30424-7. Epub 2017 Jan 6.
- Background: PubMed 33965067Syn NL, Cummings DE, Wang LZ, Lin DJ, Zhao JJ, Loh M, Koh ZJ, Chew CA, Loo YE, Tai BC, Kim G, So JB, Kaplan LM, Dixon JB, Shabbir A. Association of metabolic-bariatric surgery with long-term survival in adults with and without diabetes: a one-stage meta-analysis of matched cohort and prospective controlled studies with 174 772 participants. Lancet. 2021 May 15;397(10287):1830-1841. doi: 10.1016/S0140-6736(21)00591-2. Epub 2021 May 6.
- Background: PubMed 33295955Gronroos S, Helmio M, Juuti A, Tiusanen R, Hurme S, Loyttyniemi E, Ovaska J, Leivonen M, Peromaa-Haavisto P, Maklin S, Sintonen H, Sammalkorpi H, Nuutila P, Salminen P. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):137-146. doi: 10.1001/jamasurg.2020.5666.
- Background: PubMed 33432483Angrisani L, Santonicola A, Iovino P, Ramos A, Shikora S, Kow L. Bariatric Surgery Survey 2018: Similarities and Disparities Among the 5 IFSO Chapters. Obes Surg. 2021 May;31(5):1937-1948. doi: 10.1007/s11695-020-05207-7. Epub 2021 Jan 12.
- Background: PubMed 35731535Salminen P, Gronroos S, Helmio M, Hurme S, Juuti A, Juusela R, Peromaa-Haavisto P, Leivonen M, Nuutila P, Ovaska J. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2022 Aug 1;157(8):656-666. doi: 10.1001/jamasurg.2022.2229.
- Background: PubMed 36279044Lind RP, Ghanem M, Teixeira AF, Jawad MA, Osorio J, Lazzara C, Sobrino L, Ortiz-Ciruela D, de Gordejuela AGR. Single- Versus Double-Anastomosis Duodenal Switch: Outcomes Stratified by Preoperative BMI. Obes Surg. 2022 Dec;32(12):3869-3878. doi: 10.1007/s11695-022-06315-2. Epub 2022 Oct 24.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javier Osorio, PhD principal investigator
General & Digestive Surgery Department, ICMDM, Clinic Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SADI-S and RY-GBP in people with Obesity, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Osorio, PhD (+34932275400 ext. 5718, josorio@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with Total weight loss at 2 years > 30% (time frame: 2 years after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789965, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.