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

NCT01685177 | Unknown

• 1 other identifier: SADI-CD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Morbid Obesity

Keywords

Morbid obesity; Sleeve gastrectomy; Duodenal Switch; SADI-S

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Excess weight loss based on an ideal BMI = 25. EWL will be compared at 2 and 5 years from the second operation.

  5 years from surgery

Secondary Outcomes (1)

• Postoperative complications and nutritional complications

  First 2 postoperative years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients attended in the Surgery Clinic with Morbid Obesity submitted to a sleeve gastrectomy and needing a second-step operation.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 20798995 BACKGROUND

• 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.

  PMID: 18040751 BACKGROUND

• Sanchez-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.

  PMID: 22963820 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Fat, liver tissue

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrés Sánchez-Pernaute, MD PhD

CONTACT

+3413303184; pernaute@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Esophago-Gastric and Morbid Obesity Surgery Unit

Study Record Dates

• First Submitted: September 9, 2012
• First Posted: September 14, 2012
• Study Start: September 1, 2009
• Last Updated: September 14, 2012

Record last verified: 2012-09

Locations

ES (1)