Duodenal Obstruction, Gastrointestinal Disease, Superior Mesenteric Artery Syndrome, Weight Loss
Conditions
Keywords
Superior Mesenteric Artery Syndrome, SMAS, OAGB, One Anastomisis Gastric Bypass, Duodenojejunostomy, Gastrc Bypass, Intestinal Obstruction, Malnutrition, Minimally invasive surgery, Quality of Life, Randomized Controlled Trial
Brief summary
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
Detailed 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.
Interventions
PROCEDUREOne Anastomosis Gastric Bypass
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.
PROCEDUREDuodenojejunostomy
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to undergo either One Anastomosis Gastric Bypass (OAGB) or Duodenojejunostomy (DJ). Each participant receives one type of surgery, and outcomes are assessed after 12 months of follow-up.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Postprandial Symptoms Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | 12 months | Change in BMI from baseline to 12 months postoperatively, used to assess nutritional recovery and weight regain after surgery. |
Countries
Egypt
Outcome results
None listed