SMAS: a Prospective Study in a Single Institution

January 24, 2018 updated by: Angelica Ganss, Azienda Ospedaliera di Padova

Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution

Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008 and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of SMAS were prospectively included in the study, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PD
      • Padova, PD, Italy, 35128
        • General Surgery Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (at least 2 of the following):

  • severe and frequent upper digestive symptoms (occurring at least once a week), associated to poor quality of life and refractory response to medical treatment;
  • a condition of underweight (BMI <18.5 kg/m2) associated with difficulty eating;
  • severe complications of SMAS (e.g. gastric perforation, acute pancreatitis, aspiration pneumonia);
  • suggestive findings of SMAS at barium swallow;
  • diagnostic aortomesenteric angle and distance at CT/MR angiography.

Exclusion Criteria:

  • inability to provide the informed consent;
  • malignancies;
  • bowel motility disorders;
  • severe psychiatric illness;
  • pregnancy;
  • impossibility to perform the required diagnostic workup.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMAS patients
Procedure: Duodenojejunostomy
Duodenojejunostomy with or without duodenal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom score
Time Frame: 47 months (IQR 34-72)
Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating)
47 months (IQR 34-72)
BMI
Time Frame: 47 months (IQR 34-72)
Body mass index
47 months (IQR 34-72)
Need for medical treatment
Time Frame: 47 months (IQR 34-72)
PPIs, prokinetic drugs
47 months (IQR 34-72)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Padova

Investigators

  • Principal Investigator: Angelica Ganss, M.D., General Surgery Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOPadova

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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