Common Limb Length in One-anastomosis Gastric Bypass

NCT04357119 | Unknown

• 1 other identifier: MD/16.05.65
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of the effect of the common limb length on the outcome of laparoscopic single anastomosis gastric bypass in morbidly obese patients. Two groups of patients: one group with a common limb length of about 200 cm distal to the ligament of Treitz and the second group with a common limb length of 300 cm proximal to the ileocecal valve. Groups are evaluated regarding percentage of excess weight loss, resolution of comorbidities, and long term complications.

Conditions

Obesity, Morbid; Weight Loss; Bariatric Surgery Candidate

Keywords

One-anastomosis gastric bypass; Common limb length; Bariatric surgery; Malnutrition

Outcome Measures

Primary Outcomes (3)

• the percentage of excess weight loss

  2 years

• the percentage of total body weight loss

  2 years

• resolution or improvement of comorbidities

  cessation of treatment or reduction of medications

  2 years

Secondary Outcomes (2)

• early postoperative morbidities

  3 months

• late complications

  2 years

Study Arms (2)

CL measured from Treitz ligament

ACTIVE COMPARATOR

A 14-16 cm long gastric tube is created using a 60 mm stapler starting on the lesser curvature at the crow's foot level. It is tailored following the edge of a 38F calibrating orogastric tube up to the angle of His. A loop gastroenterostomy is then created with the small bowel about 200 cm distal to the ligament of Treitz with the same stapler using a 60 mm blue cartridge

Procedure: One-anastomosis gastric bypass

CL measured from ileocecal valve

ACTIVE COMPARATOR

A 14-16 cm long gastric tube is created using a 60 mm stapler starting on the lesser curvature at the crow's foot level. It is tailored following the edge of a 38F calibrating orogastric tube up to the angle of His. A loop gastroenterostomy is then created with the small bowel about 300 cm proximal to the ileocecal valve with the same stapler using a 60 mm blue cartridge

Procedure: One-anastomosis gastric bypass

Interventions

One-anastomosis gastric bypass PROCEDURE

Laparoscopic single anastomosis gastric bypass is reported to be a safe alternative to LRYGB, showing comparable efficacy in weight reduction and resolution of metabolic complications with reduced surgical complications. The advantages with this technique as claimed by those speaking in favor of it are many: fewer sites for leakage and internal hernia, easier and faster to learn and perform, easy to reverse and revise, and with results at least comparable with the result following standard Roux-en-Y gastric bypass (RYGB). The length of the biliopancreatic limb in single anastomosis gastric bypass as reported by Rutledge is fixed 200 cm starting at the duodenojejunal junction, neglecting the length of the common limb. Because of deficient data regarding the effect of common limb length on the outcome of LSAGB, so a clinical trial shall add new knowledge regarding sufficient weight loss, rate of complications and the need for revision.

CL measured from Treitz ligament; CL measured from ileocecal valve

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis).
• Age between 18 and 60 years old.

You may not qualify if:

• Pregnancy or desire to be pregnant during the study.
• Abnormal findings on upper GI endoscopy.
• Presence of chronic diarrhea (≥ 3 liquid or loose stools per day, over a period of more than 4 weeks).
• Obesity due to organic disease e.g, cushing disease and hypothyroidism.
• Previous bariatric surgery.
• Coexisting severe hepatic, pulmonary, renal, cardiovascular, neurological and psychiatric diseases.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss; Malnutrition

Condition Hierarchy (Ancestors)

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

Study Officials

• Ashraf Shoma

  Head of Unit 7 , Department of Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of general surgery

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: September 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: August 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The data is panned to be published as a research paper in one of the journals concerned with obesity surgery
• Access Criteria: The data is planned to be available on the journal that the research paper will be submitted to