Clinical trial NCT06664099: Comparison of Weight Loss and Nutritional Deficiency After One Anastomosis Gastric Bypass at 150, 170, and 200 cm From the Duodenojejunal Junction
Official title: Comparative Study Between One Anastomosis Gastric Bypass (OAGB) at Different Lengths of 150, 170, and 200 cm From the Duodenojejunal Junction Regarding Weight Loss and Nutritional Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Total Weight Loss
timeFrame: 12 months post-surgery
measure: Incidence of Nutritional Deficiency in Albumin
timeFrame: 12 months post-surgery
measure: Incidence of Nutritional Deficiency in Calcium
timeFrame: 12 months post-surgery
measure: Incidence of Nutritional Deficiency in Iron
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Remission Rate of Type 2 Diabetes Mellitus
timeFrame: 12 months post-surgery
measure: Improvement in Hypertension
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
References: