Morbid ObesitySADI vs CDNCT01685177
Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient
An observational study of Morbid Obesity, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to not given
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients attended in the Surgery Clinic with Morbid Obesity submitted to a sleeve gastrectomy and needing a second-step operation.
Inclusion Criteria: Morbid obesity with initial BMI over 50 submitted to Sleeve Gastrectomy more than 18 months earlier. Excess weight loss with the sleeve under 50%.
-
Exclusion Criteria: Mental retard, alcoholism, age over 60, concomitant neoplastic disease.
-
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Andrés Sánchez-Pernaute, PhD MD, +3413303184, pernaute@yahoo.com
About this study
Official title: Prospective Randomized Trial Comparing Single-Anastomosis Duodeno-Ileal Bypass With Standard Roux-en-Y Duodenal Switch as a Second Step After a Sleeve Gastrectomy in the Super-Morbid Obese Patient
Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least equally to standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid and long-term complications.
Read the detailed description
Sleeve gastrectomy is a restrictive operation for morbid obesity which has a 60% success rate in solving both morbid obesity and related co-morbidities, mainly diabetes mellitus. When the sleeve is not enough for the patient, due to alimentary habits or to an excessive initial BMI before surgery (usually over 50 - 55), a second-step operation should be performed to increase effectiveness. Some patients are submitted to a second restrictive operation, i.e.: a re-sleeve, a gastric plication or sleeve banding. Other group are offered a gastric bypass. And, finally, a subset of patients, generally those with higher initial BMI, are offered a malabsorptive operation. While re-sleeve is adequate for many patients, gastric bypass is not offering a greater weight loss rate, and it is a complex operation requiring sectioning of the sleeve and two anastomoses. We support the performance of malabsorptive operations which warrant a better weight loss result for "resistant" patients needing a second-step. As Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S) has behaved as a good primary operation for morbid obesity, we decided to test this one-loop reconstruction as a second step operation. Results will be compared to those obtained with a Roux-en-Y duodenal switch performed as a second step after a "failed" sleeve.
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, Sleeve gastrectomy, Duodenal Switch, SADI-S
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SADI | Patients submitted to a second-step operation after a failed sleeve on which a single-anastomosis duodena-ileal bypass at 250 cm from the cecum is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Excess weight loss based on an ideal BMI = 25. EWL will be compared at 2 and 5 years from the second operation.
Measured: 5 years from surgery
Secondary outcomes (1)
Postoperative complications and nutritional complications
Operative and postoperative complications (i.e.: leaks, bleeding, hernia...) will be recorded. Nutritional evolution (malnutrition) will be analyzed.
Measured: First 2 postoperative years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Sanchez-Pernaute, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685177
- Sponsor's protocol ID
- SADI-CD
- Acronym
- SADI vs CD
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2012
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.
PubMed 20798995Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.
PubMed 18040751Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.
PubMed 22963820
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Single-Anastomosis Duodeno-Ileal Bypass With Standard Roux-en-Y Duodenal Switch as a Second Step After a Sleeve Gastrectomy in the Super-Morbid Obese Patient
- ClinicalTrials.gov ID
- NCT01685177
- Acronym / sponsor ID
- SADI vs CD / SADI-CD
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, Sleeve gastrectomy, Duodenal Switch, SADI-S
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- Sep 2009
- First posted
- 14 Sep 2012 (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.
Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least equally to standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid and long-term complications.
Detailed description
Sleeve gastrectomy is a restrictive operation for morbid obesity which has a 60% success rate in solving both morbid obesity and related co-morbidities, mainly diabetes mellitus. When the sleeve is not enough for the patient, due to alimentary habits or to an excessive initial BMI before surgery (usually over 50 - 55), a second-step operation should be performed to increase effectiveness. Some patients are submitted to a second restrictive operation, i.e.: a re-sleeve, a gastric plication or sleeve banding. Other group are offered a gastric bypass. And, finally, a subset of patients, generally those with higher initial BMI, are offered a malabsorptive operation. While re-sleeve is adequate for many patients, gastric bypass is not offering a greater weight loss rate, and it is a complex operation requiring sectioning of the sleeve and two anastomoses. We support the performance of malabsorptive operations which warrant a better weight loss result for "resistant" patients needing a second-step. As Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S) has behaved as a good primary operation for morbid obesity, we decided to test this one-loop reconstruction as a second step operation. Results will be compared to those obtained with a Roux-en-Y duodenal switch performed as a second step after a "failed" sleeve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SADI | – | –Patients submitted to a second-step operation after a failed sleeve on which a single-anastomosis duodena-ileal bypass at 250 cm from the cecum is performed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients attended in the Surgery Clinic with Morbid Obesity submitted to a sleeve gastrectomy and needing a second-step operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight loss
Time frame: 5 years from surgery
Excess weight loss based on an ideal BMI = 25. EWL will be compared at 2 and 5 years from the second operation.
1 secondary outcome
Postoperative complications and nutritional complications
Time frame: First 2 postoperative years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Background: PubMed 20798995Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.
- Background: PubMed 18040751Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.
- Results publication: PubMed 22963820Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Hospital San Carlos, Madrid 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?
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 14 Sep 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrés Sánchez-Pernaute, MD PhD (+3413303184, pernaute@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 5 years from surgery). 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 NCT01685177, which also lists 3 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 14 Sep 2012.