Revisional Bariatric Surgery Experience

Bariatric Surgery Clinical Trial

Official title:

Results of Revisional Bariatric Surgery: A Single Center Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983135
• Other study ID #: BakirkoySadiKGeneralSurgery
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2019
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Eating disorders,

• Alcoholic

• Cancer

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity Associated Disorder
• Revisional Bariatric Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss (kilograms)	Amount of weight loss (kilograms) before (Day of surgery) and after (At three years) revisional bariatric surgery	3 years
Secondary	Resolution of comorbidities	The pharmacological treatment status of comorbidities related to obesity of type 2 diabetes (T2DM) and hypertension and gastroesophageal reflux will be observed with questions about "did it stop after surgery (improvement), did the dose or number of medications used reduce (resolution), or were there no changes?"comorbidities at the end of follow-up	3 years