Regain Rate According to gj Anastomosis Size in Gastric Bypass

December 9, 2022 updated by: ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital

The Effect of Gastrojejunostomy Diameters on Weight Loss in Patients Who Underwent Laparoscopic Roux n Y Gastric Bypass

Obesity has become an important medical and social problem in western countries today. Roux-en-Y gastric bypass (LRYGB) is the most commonly performed surgery for the treatment of morbid obesity in the United States. Recently, there has been a steady increase in the number of surgeons performing bariatric surgery. In 2008, approximately 344,000 bariatric procedures were performed worldwide, of which 220,000 were performed in the United States and Canada. Most of these surgeries were laparoscopic gastric bypass procedures.

There are many technical variations in the performance of the Roux-en-Y gastric bypass, especially when the approach is laparoscopic. Three techniques are commonly used when creating a gastrojejunostomy (GJ): hand-sewn, linear-staple, and circular-staple approaches. The effect of larger-caliber gastrojejunostomy on long-term weight loss is worrisome. Numerous recent reports describe the relationship between gastrojejunostomy enlargement and weight gain after gastric bypass, suggesting that this is a potentially valid concern.

In this study, we aim to determine the effect of this potential GJ enlargement on weight loss.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this prospective study, 118 patients who underwent laparoscopic Roux-en-Y gastric bypass using linear staples due to morbid obesity at Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included. The number of samples was calculated by performing impact power analysis. Informed consent form and voluntary consent form will be obtained from all patients.

In our clinic, patients who have undergone LRYGB operation are routinely performed esophagogastroscopy at the end of 1 year, as recommended in the guidelines, to detect any enlargement of the gastric pouch, any ulcers in the anatomical line, or any other pathology. In addition to this process, which is applied as a standard in this study, the measurement of the GJ diameter will be added to the process. In this study, the diameter of the gastrojejunal anastomosis will be measured during the esophago gastroscopy procedure for the patients who applied for the esophagogastroscopy procedure, which we routinely apply to all patients 1 year after the LRYGB operation. This procedure will not incur any additional cost to the routine esophagogastroscopy procedure.

At the end of the procedure, patients will be divided into 2 groups according to their GJ diameters. Those with a GJ diameter of less than 15 mm will be considered as group A, those with a GJ diameter over 15 mm will be considered as group B and evaluated for weight loss. Weight loss will be evaluated as EWL(% excess weight loss) and TWL(% total weight loss). The %TWL variable will be calculated with the formula: [(initial weight - current weight) / (initial weight)] × 100. The %EWL variable will be calculated by the formula: [(initial weight - current weight) / (initial weight - ideal weight)] × 100 The ideal weight for each patient was determined as the weight corresponding to a BMI of 25 kg/m2. The patients will be evaluated in terms of age, gender, comorbidities, preoperative BMI and postoperative BMI.

Esophagogastroscopy procedure: Upper endoscopy will be performed in a medium or deep sedation endoscopy unit. A standard endoscope will be used. The gastric pouch will be measured and examined for ulcers and additional pathologies. The gastrojejunostomy will then be measured using a pre-measured forceps. Patients will be discharged with instructions to maintain an analgesic for pain, proton pump inhibitors, sucralfate, and a clear liquid diet for the first 12 hours.

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34734
        • fatih sultan mehmet research and training hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who have undergone LRYGB operation in the last 15 months in our clinic

Exclusion Criteria:

- Patients who refused to undergo esophagogastroscopy Patients who had another abdominal operation after the operation Patients with gastric ulcer detected during esophagogastroscopy Patients with chronic analgesic use Patients with perioperative complications Patients who did not agree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: upper gi endoscopy after rygb gastric bypass / weight loss
In all patients undergoing RYGB gastric bypass and success > %50 EWL , an upper gastrointestinal endoscopy will be performed at the 1st postoperative year to measure the diameter of the gastrojejunostomy anastomosis.
Procedure: upper gi endoscopy
In all patients undergoing RYGB gastric bypass, an upper gastrointestinal endoscopy will be performed at the 1st postoperative year to measure the diameter of the gastrojejunostomy anastomosis.
Active Comparator: upper gi endoscopy after rygb gastric bypass / regain
In all patients undergoing RYGB gastric bypass and regain , an upper gastrointestinal endoscopy will be performed at the 1st postoperative year to measure the diameter of the gastrojejunostomy anastomosis.
Procedure: upper gi endoscopy
In all patients undergoing RYGB gastric bypass, an upper gastrointestinal endoscopy will be performed at the 1st postoperative year to measure the diameter of the gastrojejunostomy anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
regain by GJ anastomosis
Time Frame: 1 year
Determination of regain ratio according to anastomosis diameter in the 1st year after RYGB gastric bypass
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GJ anastomosis diameter
Time Frame: 1 year
Finding the average diameter of the gastrojejunostomy anastomosis, which is a critical point in weight loss in RYGB gastric bypass surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2022

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

January 15, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANILERGİNNNN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Patient information can be shared, especially if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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