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NCT Number: NCT06970093

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

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

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Key information

Conditions

Superior Mesenteric Artery Syndrome Body Weight Body Weight Changes Digestive System Diseases Duodenal Diseases Duodenal Obstruction Gastrointestinal Disease Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One anastomosis gastric bypass

Procedure

Participants will undergo One Anastomosis Gastric Bypass (OAGB), a laparoscopic bariatric procedure that creates a long narrow gastric pouch and anastomoses it to a loop of jejunum approximately 150-200 cm from the ligament of Treitz. This bypasses the compressed duodenum to relieve symptoms of SMAS while promoting weight gain or nutritional restoration in undernourished patients.

Other names: Mini Gastric Bypass

Duodenojejunostomy

Procedure

Participants will undergo Duodenojejunostomy (DJ), a standard surgical procedure to bypass the compressed segment of the duodenum. It involves creating an anastomosis between the duodenum and the jejunum distal to the point of compression, allowing normal food passage and relieving symptoms of Superior Mesenteric Artery Syndrome.

Other names: Duodenal Bypass

Primary outcomes

  1. Improvement in Postprandial Symptoms Scores

    Time frame: 12 months

    Change in severity of postprandial symptoms (e.g., nausea, vomiting, early satiety, abdominal pain), assessed using standardized scoring tools: the Numeric Rating Scale (NRS) and the Visual Analog Scale (VAS).

    Both scales range from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe symptoms imaginable. Higher scores reflect worse symptom severity. The Functional Living Index-Emesis (FLIE) score used to assess nausea and vomiting improvement.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: 12 months

    Change in BMI from baseline to 12 months postoperatively, used to assess nutritional recovery and weight regain after surgery.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

One Anastomosis Gastric Bypass (OAGB) vs Duodeno-jejunostomy For Treatment of Superior Mesenteric Artery Syndrome: A Prospective Randomized Control Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 14, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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