ObesityMGBNCT02601092
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Mini Gastric Bypass
A study testing Mini Gastric Bypass and Roux-en-Y Gastric Bypass in people with Obesity and Bypass Complications, run by Spital Limmattal Schlieren at 1 site in Switzerland.
Trial summary
Several retrospective studies have shown same efficiency in regard to weight loss, with a lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to Roux-en-Y gastric bypass (LRYGB). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bypass Complications
- What is being tested?
- Mini Gastric Bypass and Roux-en-Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 35
- age > 18
Who cannot join
- malignancy
- lack of compliance
- BMI > 50
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Spital Limmattal
Schlieren, Canton of Zurich, 8952
Marko Kraljevic, MD, marko.kraljevic@gmail.com
Urs Zingg, MD, urs.zingg@spital-limmattal.ch
About this study
Official title: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Mini Gastric Bypass: A Randomized Controlled Trial
Several retrospective studies have shown same efficiency in regard to weight loss, with a lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial is to compare the two procedures in respect of excess weight loss, complications, operation time, length of stay and the metabolic impact on the hormonal brain-gut-axis.
Read the detailed description
Bariatric surgery, the only effective treatment for morbid obesity, has shown effective long term weight loss and good control of obesity related comorbidities in randomized controlled trials.
Obesity related diseases, such as hypertension, type 2 diabetes, dyslipidemia, osteoarthritis and various tumours, have a significant socio-economic impact, since the cost of the obesity epidemic is 5.7 billion Swiss francs yearly.
According to the current Swiss National Guidelines defined by the Swiss Group for Morbid Obesity surgical therapy is indicated in cases of BMI 35 kg/m2 or higher, showing better weight reduction and control of comorbidties than conservative therapy alone. Obesity reduces quality of life and life expectancy dramatically. Furthermore it has a significant impact on our economy. Bariatric surgery is likely to improve all of these negative impacts on society.
The most commonly performed procedures at present are laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG).
LRYGB is considered the golden standard in bariatric surgery, although little evidence is available to justify this standpoint. In fact, the choice of the surgical procedure depends more on patient factors such as present comorbidities and operative risk. Therefore, surgeons consult after a work up within a multidisciplinary team of caretakers such as nutritionists, endocrinologists and psychiatrists and chose a patient tailored approach. Recently, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity in addition to the standard available procedures for the treatment of morbid obesity. Therefore, it has been added by the Swiss Group for Morbid Obesity as a surgical option, which has to be evaluated in clinical trials.
Robert Rutledge, the pioneer of the LMGB, published in 2001 results of 1274 patients, who received surgical treatment with LMGB. After two years the patients showed an excess weight loss (EWL) of 77%. The rate of anastomotic leakage in the gastroenterostomy amounted 1.6%. The rate of mortality was 0.08%. Subsequently, Rutledge published in 2005 the results of 2410 patients with a follow up of 38.7 months. These cohort reached/achieved an EWL of 80% after a year and even after 5 years 5% of all these patients showed a weight rebound of maximum 10 kg. In fact, those results seemed superior to outcomes of the other standard bariatric procedures.
The rate of anastomotic leakage was 1.08%, mortality 0.08%. Long-term complications were ulcer disease (4%) and iron deficiency (5%). Both complications are also known in LRYGB with similar rates.
The first and only randomized controlled trial comparing the LRYGB to LMGB was carried out by Lee in 2005. With a group of 40 patients the effectiveness of LMGB was compared to the LRYGB. The authors found an EWL of 64.9% after one and 64.4% after two years, respectively, in patients having a LMGB accompanied by less complications and a shorter hospitalization time than in LRYGB. Patients with LRYGB had an EWL of 58.7% and 60%, respectively.
These results showed similar benefits of the LMGB compared to LRYGB. This is in accordance with the already mentioned observational studies.
- Conditions
- Obesity, Bypass Complications
- Being tested
- Mini Gastric Bypass, Roux-en-Y Gastric Bypass
- Keywords
- Mini Gastric Bypass, Roux-en-Y Gastric Bypass, RCT
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Gastric BypassProcedure or surgery
The mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine.
No drugs or devices will be used.
Roux-en-Y Gastric BypassProcedure or surgery
This variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients.
No drugs or devices will be used.
| Study group | Role | What they receive |
|---|---|---|
| Mini Gastric Bypass | Experimental | The mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine.
No drugs or devices will be used. Receives: Procedure: Mini Gastric Bypass |
| Roux-en-Y Gastric Bypass | Active comparator | This variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients.
No drugs or devices will be used. Receives: Procedure: Roux-en-Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess Weight Loss
Measured: 1 year postoperative
Secondary outcomes (10)
Early surgical complications
Measured: ≤ 30 days
Early non-surgical complications
Measured: ≤ 30 days
Operation time
Operation time measured in minutes for the primary procedure (e.g. LRYGB or LMGB)
Measured: intraoperative
Length of stay
Length of stay after the primary operation (e.g. LRYGB or LMGB)
Measured: up to 24 weeks
Subjective perception of the appetite and saturation
measured by questionnaires
Measured: 6 weeks, 1 and 3 years
Hormonal assay (Ghrelin)
measured in pg/ml
Measured: preoperative, 6 weeks, 1 and 3 years
Hormonal assay (GLP-1)
measured in pg/ml
Measured: preoperative, 6 weeks, 1 and 3 years
Hormonal assay (PYY)
measured in pg/ml
Measured: preoperative, 6 weeks, 1 and 3 years
Glucose homeostasis
Measured: preoperative, 6 weeks, 1 and 3 years
Lipid profile
LDL (mg/dl), HDL (mg/dl), triglycerides (mg/dl), total cholesterol (mg/dl)
Measured: preoperative, 6 weeks, 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startOct 2016
- Primary completionNov 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spital Limmattal Schlieren
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Kraljevic, MD, Spital Limmattal Schlieren
- Investigators
- Urs Zingg, MD, Principal investigator, Spital Limmattal Schlieren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601092
- Sponsor's protocol ID
- SLS-002
- Acronym
- MGB
- Status last verified
- Feb 2017
- First submitted
- 28 Sep 2015
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
PubMed 17715408Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
PubMed 17715409Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
PubMed 25105982Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
PubMed 11433900Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.
PubMed 15973097Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.
PubMed 16259892Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
PubMed 23011462Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3-60 month follow-up. Obes Surg. 2000 Jun;10(3):233-9. doi: 10.1381/096089200321643511.
PubMed 10929154Rutledge R. Similarity of Magenstrasse-and-Mill and Mini-Gastric bypass. Obes Surg. 2003 Apr;13(2):318. doi: 10.1381/096089203764467315. No abstract available.
PubMed 12740148Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. doi: 10.1097/01.sla.0000217592.04061.d5.
PubMed 17060766Delko T, Kraljevic M, Lazaridis II, Kostler T, Jomard A, Taheri A, Lutz TA, Osto E, Zingg U. Laparoscopic Roux-Y-gastric bypass versus laparoscopic one-anastomosis gastric bypass for obesity: clinical & metabolic results of a prospective randomized controlled trial. Surg Endosc. 2024 Jul;38(7):3875-3886. doi: 10.1007/s00464-024-10907-7. Epub 2024 Jun 3.
PubMed 38831218Kraljevic M, Delko T, Kostler T, Osto E, Lutz T, Thommen S, Droeser RA, Rothwell L, Oertli D, Zingg U. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial. Trials. 2017 May 22;18(1):226. doi: 10.1186/s13063-017-1957-9.
PubMed 28532499
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Mini Gastric Bypass: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02601092
- Acronym / sponsor ID
- MGB / SLS-002
- Conditions
- Obesity, Bypass Complications
- Keywords
- Mini Gastric Bypass, Roux-en-Y Gastric Bypass, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Spital Limmattal SchlierenUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Nov 2015 (estimated)
- 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.
Several retrospective studies have shown same efficiency in regard to weight loss, with a lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial is to compare the two procedures in respect of excess weight loss, complications, operation time, length of stay and the metabolic impact on the hormonal brain-gut-axis.
Detailed description
Bariatric surgery, the only effective treatment for morbid obesity, has shown effective long term weight loss and good control of obesity related comorbidities in randomized controlled trials.
Obesity related diseases, such as hypertension, type 2 diabetes, dyslipidemia, osteoarthritis and various tumours, have a significant socio-economic impact, since the cost of the obesity epidemic is 5.7 billion Swiss francs yearly.
According to the current Swiss National Guidelines defined by the Swiss Group for Morbid Obesity surgical therapy is indicated in cases of BMI 35 kg/m2 or higher, showing better weight reduction and control of comorbidties than conservative therapy alone. Obesity reduces quality of life and life expectancy dramatically. Furthermore it has a significant impact on our economy. Bariatric surgery is likely to improve all of these negative impacts on society.
The most commonly performed procedures at present are laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG).
LRYGB is considered the golden standard in bariatric surgery, although little evidence is available to justify this standpoint. In fact, the choice of the surgical procedure depends more on patient factors such as present comorbidities and operative risk. Therefore, surgeons consult after a work up within a multidisciplinary team of caretakers such as nutritionists, endocrinologists and psychiatrists and chose a patient tailored approach. Recently, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity in addition to the standard available procedures for the treatment of morbid obesity. Therefore, it has been added by the Swiss Group for Morbid Obesity as a surgical option, which has to be evaluated in clinical trials.
Robert Rutledge, the pioneer of the LMGB, published in 2001 results of 1274 patients, who received surgical treatment with LMGB. After two years the patients showed an excess weight loss (EWL) of 77%. The rate of anastomotic leakage in the gastroenterostomy amounted 1.6%. The rate of mortality was 0.08%. Subsequently, Rutledge published in 2005 the results of 2410 patients with a follow up of 38.7 months. These cohort reached/achieved an EWL of 80% after a year and even after 5 years 5% of all these patients showed a weight rebound of maximum 10 kg. In fact, those results seemed superior to outcomes of the other standard bariatric procedures.
The rate of anastomotic leakage was 1.08%, mortality 0.08%. Long-term complications were ulcer disease (4%) and iron deficiency (5%). Both complications are also known in LRYGB with similar rates.
The first and only randomized controlled trial comparing the LRYGB to LMGB was carried out by Lee in 2005. With a group of 40 patients the effectiveness of LMGB was compared to the LRYGB. The authors found an EWL of 64.9% after one and 64.4% after two years, respectively, in patients having a LMGB accompanied by less complications and a shorter hospitalization time than in LRYGB. Patients with LRYGB had an EWL of 58.7% and 60%, respectively.
These results showed similar benefits of the LMGB compared to LRYGB. This is in accordance with the already mentioned observational studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini Gastric Bypass | Experimental | Procedure: Mini Gastric BypassThe mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine. No drugs or devices will be used. |
| Roux-en-Y Gastric Bypass | Active comparator | Procedure: Roux-en-Y Gastric BypassThis variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients. No drugs or devices will be used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 35
- age > 18
Key exclusion criteria (3 listed)
- malignancy
- lack of compliance
- BMI > 50
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 |
|---|---|---|
| Mini Gastric BypassThe mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine. No drugs or devices will be used. | Procedure or surgery | Mini Gastric Bypass |
| Roux-en-Y Gastric BypassThis variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients. No drugs or devices will be used. | Procedure or surgery | Roux-en-Y Gastric Bypass |
Primary outcome
Excess Weight Loss
Time frame: 1 year postoperative
10 secondary outcomes
Early surgical complications
Time frame: ≤ 30 days
Early non-surgical complications
Time frame: ≤ 30 days
Operation time
Time frame: intraoperative
Length of stay
Time frame: up to 24 weeks
Subjective perception of the appetite and saturation
Time frame: 6 weeks, 1 and 3 years
Hormonal assay (Ghrelin)
Time frame: preoperative, 6 weeks, 1 and 3 years
Hormonal assay (GLP-1)
Time frame: preoperative, 6 weeks, 1 and 3 years
Hormonal assay (PYY)
Time frame: preoperative, 6 weeks, 1 and 3 years
Glucose homeostasis
Time frame: preoperative, 6 weeks, 1 and 3 years
Lipid profile
Time frame: preoperative, 6 weeks, 1 and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Results publication: PubMed 17715408Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
- Results publication: PubMed 17715409Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
- Results publication: PubMed 25105982Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
- Results publication: PubMed 11433900Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
- Results publication: PubMed 15973097Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.
- Results publication: PubMed 16259892Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.
- Results publication: PubMed 23011462Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
- Results publication: PubMed 10929154Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3-60 month follow-up. Obes Surg. 2000 Jun;10(3):233-9. doi: 10.1381/096089200321643511.
- Results publication: PubMed 12740148Rutledge R. Similarity of Magenstrasse-and-Mill and Mini-Gastric bypass. Obes Surg. 2003 Apr;13(2):318. doi: 10.1381/096089203764467315. No abstract available.
- Results publication: PubMed 17060766Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. doi: 10.1097/01.sla.0000217592.04061.d5.
- Derived from this study: PubMed 38831218Delko T, Kraljevic M, Lazaridis II, Kostler T, Jomard A, Taheri A, Lutz TA, Osto E, Zingg U. Laparoscopic Roux-Y-gastric bypass versus laparoscopic one-anastomosis gastric bypass for obesity: clinical & metabolic results of a prospective randomized controlled trial. Surg Endosc. 2024 Jul;38(7):3875-3886. doi: 10.1007/s00464-024-10907-7. Epub 2024 Jun 3.
- Derived from this study: PubMed 28532499Kraljevic M, Delko T, Kostler T, Osto E, Lutz T, Thommen S, Droeser RA, Rothwell L, Oertli D, Zingg U. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial. Trials. 2017 May 22;18(1):226. doi: 10.1186/s13063-017-1957-9.
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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. This study is not recruiting at the moment.
Urs Zingg, MD principal investigator
Spital Limmattal Schlieren
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Gastric Bypass and Roux-en-Y Gastric Bypass in people with Obesity and Bypass Complications, run by Spital Limmattal Schlieren at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Feb 2017. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marko Kraljevic, MD (+41 79 942 50 10, marko.kraljevic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess Weight Loss (time frame: 1 year postoperative). 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 NCT02601092, which also lists 12 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 27 Feb 2017.