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Regain Rate According to gj Anastomosis Size in Gastric Bypass

NCT ID: NCT05655975

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-01-15

Brief Summary

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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

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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.

Conditions

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Obesity, Morbid Anastomosis Roux-en-y Anastomosis Site

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

upper gi endoscopy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

upper gi endoscopy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ANIL ERGIN

Uzman Doktor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fatih Sultan Mehmet Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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ANIL ERGİN

Role: CONTACT

Phone: +905342245364

Email: [email protected]

Facility Contacts

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anıl ergin

Role: primary

Other Identifiers

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ANILERGİNNNN

Identifier Type: -

Identifier Source: org_study_id