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

NCT ID: NCT06664099

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-06-20

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One Anastomosis Gastric Bypass at 150 cm from Duodenojejunal Junction

Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 150 centimeters from the duodenojejunal junction. This approach aims to achieve weight loss while potentially minimizing nutritional deficiencies by utilizing a shorter bypass length. Postoperative outcomes will be monitored, focusing on weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers such as albumin, calcium, and iron levels.

Group Type: EXPERIMENTAL

One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction)

Intervention Type: PROCEDURE

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.

One Anastomosis Gastric Bypass at 170 cm from Duodenojejunal Junction

Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 170 centimeters from the duodenojejunal junction. This approach aims to balance effective weight loss and nutritional outcomes with an intermediate limb length. Postoperative outcomes will include measurements of weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers, such as albumin, calcium, and iron levels.

Group Type: EXPERIMENTAL

One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction)

Intervention Type: PROCEDURE

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.

One Anastomosis Gastric Bypass at 200 cm from Duodenojejunal Junction

Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 200 centimeters from the duodenojejunal junction. This approach prioritizes maximizing weight loss but may carry a higher risk of nutritional deficiencies due to the longer bypass length. Postoperative outcomes will be evaluated for weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers, including albumin, calcium, and iron levels.

Group Type: EXPERIMENTAL

One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 to 60 years.
• Body Mass Index (BMI) of 35 kg/m² or higher, or BMI of 30 kg/m² or higher with significant obesity-related comorbidities.
• Failed adequate conservative management (diet, exercise, and/or medication) for at least 6 months.
• Demonstrated psychological stability and motivation for surgery.
• Acceptance of the surgical risks associated with bariatric procedures.

Exclusion Criteria

• Prior abdominal exploratory surgery.
• Previous bariatric surgery.
• Pre-existing significant nutritional deficiencies.
• Pregnancy or current lactation.
• Severe, long-standing cardiac or pulmonary disease or other serious systemic illnesses.
• Active substance or alcohol abuse.
• Active gastric ulcer disease.
• Psychological instability.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abdelkarem Ahmed Abdelkarem Mohamed

Lecturer of General Surgery, Faculty of Medicine - Cairo University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-123-2023

Identifier Type: -

Identifier Source: org_study_id