Regain Rate According to gj Anastomosis Size in Gastric Bypass

NCT05655975 | Unknown DMC

• 1 other identifier: ANILERGİNNNN
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Morbid; Anastomosis; Roux-en-y Anastomosis Site

Keywords

morbid obesity; Roux n Y gastric bypass; anastomosis diameter; regain; weight loss

Outcome Measures

Primary Outcomes (1)

• regain by GJ anastomosis

  Determination of regain ratio according to anastomosis diameter in the 1st year after RYGB gastric bypass

  1 year

Secondary Outcomes (1)

• GJ anastomosis diameter

  1 year

Study Arms (2)

upper gi endoscopy after rygb gastric bypass / weight loss

ACTIVE COMPARATOR

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

upper gi endoscopy after rygb gastric bypass / regain

ACTIVE COMPARATOR

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

Interventions

upper gi endoscopy PROCEDURE

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.

upper gi endoscopy after rygb gastric bypass / regain; upper gi endoscopy after rygb gastric bypass / weight loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss

Interventions

Endoscopy, Digestive System

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

ANIL ERGİN

CONTACT

+905342245364; dranilergin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The surgeon who will perform the endoscopy after the Roux nY gastric bypass will not know the preoperative body measurements of the patient and the post-operative weight loss, and the patient who has undergone endoscopy will not know the diameter of the gastrojejunostomy anastomosis. Only the person collecting the data of the study will be able to see these results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Uzman Doktor

Model Details: All patients undergoing Roux nY gastric bypass will have their anastomotic diameter measured by performing an upper gastrointestinal endoscopy postoperatively. The effect of anastomosis diameter on weight loss will be investigated. All patients will be compared by recording their %EWL, height, weight and BMI values during endoscopy.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: December 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: January 15, 2024
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

TU (1)