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SMAS: a Prospective Study in a Single Institution

NCT ID: NCT03416647

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Superior Mesenteric Artery Syndrome

Keywords

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Superior Mesenteric Artery Syndrome Chronic duodenal obstruction Duodenojejunostomy Wilkie's syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SMAS patients

Group Type EXPERIMENTAL

Duodenojejunostomy

Intervention Type PROCEDURE

Duodenojejunostomy with or without duodenal resection

Interventions

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Duodenojejunostomy

Duodenojejunostomy with or without duodenal resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Padova

OTHER

Sponsor Role lead

Responsible Party

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Angelica Ganss

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelica Ganss, M.D.

Role: PRINCIPAL_INVESTIGATOR

General Surgery Unit

Locations

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General Surgery Unit

Padua, PD, Italy

Site Status

Countries

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Italy

References

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Ganss A, Rampado S, Savarino E, Bardini R. Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution. J Gastrointest Surg. 2019 May;23(5):997-1005. doi: 10.1007/s11605-018-3984-6. Epub 2018 Oct 5.

Reference Type DERIVED
PMID: 30291587 (View on PubMed)

Other Identifiers

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AOPadova

Identifier Type: -

Identifier Source: org_study_id