Retrospective Analysis on Small Bowel Perforations | NCT05471999

Studies
Retrospective Analysis on Small Bowel Perforations

NCT05471999

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

May 9, 2023Actual

Enrollment

270Actual

Phase

Not Applicable

Conditions

Small Bowel Perforations

Interventions

surgery

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Feb 15, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Jul 20, 2022

First Submission Date that Met QC Criteria

Jul 20, 2022

First Posted Date

Jul 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2023

Last Update Posted Date

May 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

270Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with SBP	Other		Procedure: surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure	interventional or surgical treatment	Patients with SBP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rate	death by SBP	30 days

Secondary Outcomes

Measure	Description	Time Frame
Small bowel syndrome	malabsorption	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

small bowel perforation in adults

Exclusion Criteria:

age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
S. Bethge, Prof. Dr.	Zentrum für klinische Studien der UNiversitätsklinik Tübingen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Tuebingen		Tübingen		72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Methods would be shared

Types

Study Protocol

Time Frame

6 months

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided