Comparison of Weight Loss and Nutritional Deficiency After One Anastomosis Gastric Bypass at 150, 170, and 200 cm From the Duodenojejunal Junction

Summary

This study is a randomized clinical trial comparing the effects of One Anastomosis Gastric Bypass performed at three different distances from the duodenojejunal junction-150 centimeters, 170 centimeters, and 200 centimeters-on weight loss outcomes and nutritional status in patients with obesity. One Anastomosis Gastric Bypass is a type of bariatric surgery that combines aspects of a gastric sleeve and a traditional gastric bypass, aiming to achieve effective weight loss and improvement in health conditions associated with obesity.

The study will include 60 adult patients between 18 and 60 years old with a Body Mass Index of 35 kilograms per square meter or greater, or a Body Mass Index of 30 kilograms per square meter or greater with obesity-related health conditions, who have not achieved adequate results through diet, exercise, or medication. Participants will be randomly assigned to one of three groups, each undergoing One Anastomosis Gastric Bypass with a different limb length from the duodenojejunal junction: 150 centimeters, 170 centimeters, or 200 centimeters.

The primary outcomes measured will include the percentage of total weight loss, the percentage of excess weight loss, and postoperative nutritional status, particularly in terms of levels of albumin, calcium, iron, and ferritin. Secondary outcomes will assess the remission of health conditions related to obesity, including high blood pressure and type 2 diabetes mellitus, as well as patient quality of life following surgery.

By examining the impact of One Anastomosis Gastric Bypass at varying limb lengths on weight loss and nutritional deficiencies, this study aims to identify an optimal surgical approach that balances effective weight management and minimizes the risk of postoperative malnutrition. The findings will inform surgical decision-making and postoperative management strategies for individuals undergoing One Anastomosis Gastric Bypass.

Conditions

• Obesity
• Nutritional Deficiency
• Type 2 Diabetes Mellitus (T2DM)
• Bariatric Surgery (Gastric Bypass)

Interventions

PROCEDURE

One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction)

This intervention involves performing a One Anastomosis Gastric Bypass surgery with the bypassed length of the small intestine set at 150 centimeters from the duodenojejunal junction. This shorter limb length is designed to achieve weight loss while potentially reducing the risk of nutritional deficiencies. The procedure is performed laparoscopically, with the stomach divided to create a gastric tube attached to a loop of the small intestine. Postoperative outcomes will include assessments of weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers such as albumin, calcium, and iron.

PROCEDURE

One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction)

This intervention involves performing a One Anastomosis Gastric Bypass surgery with a bypassed length of 170 centimeters from the duodenojejunal junction, offering an intermediate limb length. This distance is intended to balance weight loss effectiveness with moderate risks of nutritional deficiencies. The laparoscopic procedure involves creating a gastric tube attached to a segment of the small intestine, bypassing the proximal portion. Outcomes monitored postoperatively include weight loss, percentage of total and excess weight loss, and nutritional parameters such as albumin, calcium, and iron levels.

PROCEDURE

One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)

This intervention consists of performing a One Anastomosis Gastric Bypass with the bypass length set at 200 centimeters from the duodenojejunal junction. This longer bypass length is designed to maximize weight loss outcomes but may carry a higher risk of nutritional deficiencies. The procedure is done laparoscopically, where the stomach is divided, creating a tube that is joined to the small intestine at the specified length. Postoperative assessments will focus on weight loss effectiveness, total and excess weight loss percentages, and the risk of nutritional deficiencies by measuring markers such as albumin, calcium, and iron.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2024-06-20

Completion

2024-06-20

Countries

• Egypt

Study Locations