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

NCT06664099 | Completed

• 1 other identifier: MD-123-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Keywords

One Anastomosis Gastric Bypass; Duodenojejunal Junction; Weight Loss Surgery; Bariatric Surgery; Nutritional Deficiency; Obesity Treatment; Postoperative Nutrition

Outcome Measures

Primary Outcomes (4)

• Percentage of Total Weight Loss

  This outcome measures the percentage of total weight loss achieved by participants one year after undergoing One Anastomosis Gastric Bypass at specified lengths (150 cm, 170 cm, or 200 cm from the duodenojejunal junction). Total weight loss is calculated as the percentage change in body weight from the initial weight measured preoperatively. This measure provides insight into the effectiveness of different bypass lengths in achieving weight loss in patients with obesity.

  12 months post-surgery

• Incidence of Nutritional Deficiency in Albumin

  This outcome measures the incidence of albumin deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Albumin deficiency is defined as serum albumin levels below 3.0 g/dL, indicating a risk of protein malnutrition. This outcome will help assess the nutritional impact of different bypass lengths.

  12 months post-surgery

• Incidence of Nutritional Deficiency in Calcium

  This outcome measures the incidence of calcium deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Calcium deficiency is defined as serum calcium levels below 8.5 mg/dL, which can indicate a risk of bone health complications and overall nutritional deficiency. This measure will evaluate the impact of different bypass lengths on calcium levels.

  12 months post-surgery

• Incidence of Nutritional Deficiency in Iron

  This outcome measures the incidence of iron deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Iron deficiency is defined as serum iron levels below 50 µg/dL, indicating a risk of anemia and associated health complications. This outcome will help assess the influence of different bypass lengths on iron absorption and nutritional status.

  12 months post-surgery

Secondary Outcomes (2)

• Remission Rate of Type 2 Diabetes Mellitus

  12 months post-surgery

• Improvement in Hypertension

  12 months post-surgery

Study Arms (3)

One Anastomosis Gastric Bypass at 150 cm from Duodenojejunal Junction

EXPERIMENTAL

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.

Procedure: One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction)

One Anastomosis Gastric Bypass at 170 cm from Duodenojejunal Junction

EXPERIMENTAL

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.

Procedure: One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction)

One Anastomosis Gastric Bypass at 200 cm from Duodenojejunal Junction

EXPERIMENTAL

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.

Procedure: One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)

Interventions

One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction) 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 150 cm from Duodenojejunal Junction

One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction) 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 170 cm from Duodenojejunal Junction

One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction) 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.

One Anastomosis Gastric Bypass at 200 cm from Duodenojejunal Junction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Obesity; Malnutrition; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery, Faculty of Medicine - Cairo University, Egypt

Model Details: This study uses a parallel design to compare the outcomes of One Anastomosis Gastric Bypass at three different distances (150 cm, 170 cm, and 200 cm) from the duodenojejunal junction in separate groups to assess weight loss and nutritional deficiency.

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: June 20, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD and supporting information will be available starting 12 months after study completion and will be accessible for 5 years.
• Access Criteria: Data will be available to qualified researchers upon request. Requests for access must include a research proposal and demonstrate ethical approval for the proposed analysis. Access to the IPD and supporting documents will be granted via a secure data-sharing platform following approval.

Locations

EG (1)