Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Brief Summary

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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

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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

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Morbid Obesity

Keywords

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Morbid obesity Sleeve gastrectomy Duodenal Switch SADI-S

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Andres Sanchez-Pernaute

Chief, Esophago-Gastric and Morbid Obesity Surgery Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clínico San Carlos

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Andrés Sánchez-Pernaute, MD PhD

Role: CONTACT

Phone: +3413303184

Email: [email protected]

Facility Contacts

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Andrés Sánchez-Pernaute, PhD MD

Role: primary

References

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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.

Reference Type BACKGROUND

PMID: 20798995 (View on PubMed)

Sanchez-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.