NCT05471999

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

May 9, 2023

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

July 20, 2022

Last Update Submit

May 8, 2023

Conditions

Small Bowel Perforations

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    death by SBP

    30 days

Secondary Outcomes (1)

  • Small bowel syndrome

    30 days

Study Arms (1)

Patients with SBP

OTHER
Procedure: surgery

Interventions

surgeryPROCEDURE

interventional or surgical treatment

Patients with SBP

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • small bowel perforation in adults

You may not qualify if:

  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • S. Bethge, Prof. Dr.

    Zentrum für klinische Studien der UNiversitätsklinik Tübingen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Retrospective data analysis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 25, 2022

Study Start

June 1, 2019

Primary Completion

February 15, 2022

Study Completion

March 1, 2022

Last Updated

May 9, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Methods would be shared

Shared Documents
STUDY PROTOCOL
Time Frame
6 months

Locations

DE(1)