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Regain Rate According to gj Anastomosis Size in Gastric Bypass

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
upper gi endoscopy
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity, Morbid focused on measuring morbid obesity, Roux n Y gastric bypass, anastomosis diameter, regain, weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fatih Sultan Mehmet Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

upper gi endoscopy after rygb gastric bypass / weight loss

upper gi endoscopy after rygb gastric bypass / regain

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

GJ anastomosis diameter
Finding the average diameter of the gastrojejunostomy anastomosis, which is a critical point in weight loss in RYGB gastric bypass surgery

Full Information

First Posted
December 9, 2022
Last Updated
December 9, 2022
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05655975
Brief Title
Regain Rate According to gj Anastomosis Size in Gastric Bypass
Official Title
The Effect of Gastrojejunostomy Diameters on Weight Loss in Patients Who Underwent Laparoscopic Roux n Y Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Anastomosis, Roux-en-y Anastomosis Site
Keywords
morbid obesity, Roux n Y gastric bypass, anastomosis diameter, regain, weight loss

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
upper gi endoscopy after rygb gastric bypass / weight loss
Arm Type
Active Comparator
Arm Description
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.
Arm Title
upper gi endoscopy after rygb gastric bypass / regain
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
upper gi endoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
regain by GJ anastomosis
Description
Determination of regain ratio according to anastomosis diameter in the 1st year after RYGB gastric bypass
Time Frame
1 year
Secondary Outcome Measure Information:
Title
GJ anastomosis diameter
Description
Finding the average diameter of the gastrojejunostomy anastomosis, which is a critical point in weight loss in RYGB gastric bypass surgery
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANIL ERGİN
Phone
+905342245364
Email
dranilergin@gmail.com
Facility Information:
Facility Name
Fatih Sultan Mehmet Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
anıl ergin
Phone
+902165783000
Email
dranilergin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Patient information can be shared, especially if requested.

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Regain Rate According to gj Anastomosis Size in Gastric Bypass

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