Duodenostomy to Treat Duodenal Perforation

May 6, 2022 updated by: Mario Pacilli, University of Foggia

Duodenostomy on Foley and Gastroenteroanastomosis: Treatment of Second Duodenal Part Perforation.

In this study the investigators focused on duodenal perforations, requiring a tube duodenostomy and have analyzed the main features, that have influenced the surgical choices. Five patients were enrolled. Most of duodenal perforations can successfully be managed by simple repair, while complicated procedures are needed for complex injuries. Tube duodenostomy is a damage control procedure, for large duodenal perforations when further repair techniques are not recommended due to the duodenal damage, hemodynamic instability of the patient or the absence of surgical expertise for complex reconstruction.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5

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
      • Foggia, Italy, 71122
        • Policlinico di Foggia

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

No older than 89 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In 2 cases a tube duodenostomy was executed, due to excessive size of perforation and extreme presence of intra-abdominal infections.

In addition, other cases of duodenal injury due to other causes were treated, 3 of these requiring a tube duodenostomy approach.

Description

Inclusion Criteria:

  • excessive size of perforation
  • extreme presence of intra-abdominal infections.

Exclusion Criteria:

  • patients treated by medical therapy, endoscopic techniques, o surgical approaches

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death of patient
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

University of Foggia

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 (Actual)

September 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UFoggia

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.

Clinical Trials on The Focus of Study is to Elucidate Which Are the Factors Requiring the Duodenostomy and Which Postoperative Course is for These Patients

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Drug Interventions

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Conditions

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