Retrospective Analysis on Small Bowel Perforations (SBP)

May 8, 2023 updated by: University Hospital Tuebingen

Small Bowel Perforations: Etiology, Treatment and Outcome

A retrospective, monocentric, code-related data analysis of patients with small bowel perforations was performed for the period 2010 to 2019.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Analyzed parameters were etiology and timing of perforation, associated morbidity and mortality, type of therapy and its success, and long-term consequences for patients, such as the development of short bowel syndrome.

Study Type

Interventional

Enrollment (Actual)

270

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

  • Germany
      • Tuebingen, Germany, 72076
        • University Hospital Of Tuebingen

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • small bowel perforation in adults

Exclusion Criteria:

  • age < 18 years

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
Other: Patients with SBP
Procedure: surgery
interventional or surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rate
Time Frame: 30 days
death by SBP
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small bowel syndrome
Time Frame: 30 days
malabsorption
30 days

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Investigators

  • Study Chair: S. Bethge, Prof. Dr., Zentrum für klinische Studien der UNiversitätsklinik Tübingen

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)

June 1, 2019

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 489/2020BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Methods would be shared

IPD Sharing Time Frame

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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