Comparison of One Anastomisis Gastric Bypass and Duodeno-Jejunostomy for Treating SMA Syndrome

Ain Shams University

Status: Completed

Conditions: Weight Loss; Gastrointestinal Disease; Duodenal Obstruction; Superior Mesenteric Artery Syndrome

Treatments: Procedure: One Anastomosis Gastric Bypass; Procedure: Duodenojejunostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06970093

11/2024

Details and patient eligibility

About

The goal of this clinical trial is to find out which surgery works better to treat people with a rare condition called Superior Mesenteric Artery Syndrome (SMAS). This condition causes the duodenum to be squeezed between two arteries, leading to severe nausea, vomiting, and weight loss. The researchers are comparing two types of surgery:

• One Anastomosis Gastric Bypass (OAGB)
• Duodeno-jejunostomy (DJ)

The main questions this study will answer are:

• Which surgery improves symptoms and nutritional status better?
• Which surgery leads to fewer complications and better quality of life?

Participants will:

• Be randomly assigned to one of the two surgeries
• Be followed for 12 months after the operation
• Complete follow-up visits and nutritional assessments
• Answer questions about their symptoms and overall well-being

Full description

Superior Mesenteric Artery Syndrome (SMAS) is a rare but serious condition where part of the small intestine (the duodenum) gets compressed between major blood vessels. This can cause severe digestive symptoms and weight loss. Surgery is often needed when other treatments do not work.

This prospective randomized controlled trial compares two surgical options to relieve the compression: One Anastomosis Gastric Bypass (OAGB) and Duodeno-jejunostomy (DJ). Both surgeries aim to improve food passage and relieve symptoms, but they work differently and have different effects on digestion and nutrition.

Participants will be randomly assigned to one of the two surgical procedures. The study will collect data before and after surgery on symptoms, nutritional status, complications, and quality of life. Follow-up will continue for 12 months.

The goal is to help surgeons and patients choose the most effective and safest surgical treatment for SMAS.

Enrollment: 20 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Superior Mesenteric Artery Syndrome (SMAS) based on symptoms and radiologic findings
• No prior gastric or intestinal surgery
• Willingness and ability to participate in follow-up for 12 months

Exclusion criteria

• Presence of other gastrointestinal pathologies mimicking SMAS
• Severe comorbidities contraindicating surgery (e.g., advanced cardiac or pulmonary disease)
• History of previous bariatric or upper GI surgery
• Refusal or inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

OAGB Surgery Group

Experimental group

Description:

Participants in this arm will undergo One Anastomosis Gastric Bypass (OAGB). The procedure involves creating a long gastric pouch and connecting it to a loop of the jejunum. This reroutes food to bypass the compressed duodenum, aiming to relieve symptoms of Superior Mesenteric Artery Syndrome (SMAS) while preserving nutritional status.

Treatment:

Procedure: One Anastomosis Gastric Bypass

Duodenojejunostomy Group

Active Comparator group

Description:

Participants in this arm will undergo Duodenojejunostomy (DJ), a surgical procedure in which a bypass connection is made between the duodenum and the jejunum. This relieves the duodenal compression caused by SMAS and restores normal food passage.

Treatment:

Procedure: Duodenojejunostomy