An interventional study of One Anastomosis Gastric Bypass and Duodenojejunostomy in Superior Mesenteric Artery Syndrome, Duodenal Obstruction and Weight Loss, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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:
The main questions this study will answer are:
Participants will:
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Gastrointestinal Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: One Anastomosis Gastric Bypass
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.
Procedure: Duodenojejunostomy
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.
Also known as: Mini Gastric Bypass
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.
Also known as: Duodenal Bypass
Improvement in Postprandial Symptoms Scores
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.
Time frame: 12 months
Change in Body Mass Index (BMI)
Change in BMI from baseline to 12 months postoperatively, used to assess nutritional recovery and weight regain after surgery.
Time frame: 12 months
Plan to share: Yes — De-identified individual participant data (IPD) related to primary and secondary outcome measures will be available to researchers upon reasonable request after the study is published. Data sharing will be considered for academic and clinical research purposes.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Starting 3 months after publication of the primary results and for up to 3 years after publication
Access criteria: De-identified individual participant data (IPD) and supporting documents such as the study protocol and statistical analysis plan will be available to qualified researchers, academic institutions, or healthcare professionals. These individuals must submit a written request with a sound scientific rationale for secondary analysis. Access will be granted at the discretion of the principal investigator. Approved users must sign a data use agreement to ensure confidentiality and appropriate use. All requests should be sent to the principal investigator's official institutional email address.
Ran from Mar 2024 to primary completion in Apr 2024, 1 month.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 1 month is below that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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