Revisional Bariatric Surgery Experience

NCT03983135 | Completed

• 1 other identifier: BakırkoySadiKGeneralSurgery
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision surgery types, indications of revision, outcomes of revisional surgery and follow-up data for comorbidities will investigated.

Conditions

Bariatric Surgery; Revisional Bariatric Surgery; Obesity Associated Disorder

Outcome Measures

Primary Outcomes (1)

• Weight loss (kilograms)

  Amount of weight loss (kilograms) before (Day of surgery) and after (At three years) revisional bariatric surgery

  3 years

Secondary Outcomes (1)

• Resolution of comorbidities

  3 years

Study Arms (1)

Study group

EXPERIMENTAL

Patients who undergo revisional bariatric surgery

Other: Laparoscopic mini gastric by-pass; Other: LaparoscopicRe-sleeve gastrectomy; Other: Laparoscopic Roux-en-Ygastric bypass

Interventions

Laparoscopic mini gastric by-pass OTHER

Adhesions will separated along the left edge of the stomach and the left lobe of the liver. The remnant stomach will transected at the incisura angularis level with 60 mm Endo-GIA stapler(ATW 35, EthiconEndo-SurgeryInc., Cincinnati, OH, USA). Later ante-cholic distal of the Treitz ligament hadgastro-jejunal anastomosisof nearly 150 cm jejunal loop performed with 44 mm Endo-GIA stapler. Routinely, the omentum will be divided in two and omentopexy will be performed around the anastomosis. The stapler line will supported by absorbable stitches.

Study group

LaparoscopicRe-sleeve gastrectomy OTHER

Adhesions will be separated with blunt and sharp dissections, then the remnant stomach will completely freed. Due to dilated antral pouch or fundus, the remnant stomach will resect as a tube stomach between the pillory and left crus with 60 mm Endo-GIA stapler accompanied by 36F bougie.

Study group

Laparoscopic Roux-en-Ygastric bypass OTHER

all adhesions will separated then after the stomach pouch will formed by the linear stapler, 100 cm of jejunum will transected from the Treitz ligament. Side-to-side gastrojejunostomy will performed for the distal jejunum with the linear stapler. The anterior face of the anastomosis will manually sutured. Proximal jejunum end hadside-to-side jejuno-jejunostomy performed 150 cm distal of the gastrojejunostomy anastomosis with linear stapler on the posterior wall and manual suturing of the anterior wall.

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 to 65 years old,
• Patients who undergo revisional bariatric surgery due to renewed weight gain, stenosis or alkaline reflux after primary bariatric surgery

You may not qualify if:

• Eating disorders,
• Alcoholic
• Cancer

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: June 12, 2019
• Study Start: March 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 12, 2019

Record last verified: 2019-06