Morbidity After Surgical Treatment of Perforated Ulcer | NCT05489497

Studies
Morbidity After Surgical Treatment of Perforated Ulcer

NCT05489497

Sponsor

University of Monastir

Status

Completed

Last Update Posted

Aug 5, 2022Actual

Enrollment

116Estimated

Phase

Not provided

Conditions

Peptic Ulcer Perforation

Interventions

Primary closure with or without omental grafting

Countries

Not provided

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

Aug 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

Jan 1, 2010Actual

Primary Completion Date

May 1, 2021Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Aug 1, 2022

First Submission Date that Met QC Criteria

Aug 3, 2022

First Posted Date

Aug 5, 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

Aug 3, 2022

Last Update Posted Date

Aug 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The main objective of our study is to identify the risk factors for postoperative morbidity after surgical treatment of Perforated peptic ulcer

Detailed Description

the investigators conducted a retrospective study of 116 patients, operated on for a perforated peptic ulcer, carried out in the General Surgery Department of Taher Sfar University Hospital in Mahdia over a period of 11 years 6 months.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Primary closure with or without omental grafting	Procedure	Primary closure with or without omental grafting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative medical or surgical complication	the investigators determined the number of Participants With postoperative medical or surgical complication after surgical treatement of perforated ulcer	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent surgery for a perforated peptic ulcer in the General Surgery Department of Taher Sfar University Hospital in Mahdia, between January 1, 2010, and June 1, 2021, were included in this study.

Exclusion Criteria:

patients who have medical treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient who presented to tahar sfar hospital for perforated ulcer

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010439	Peptic Ulcer Perforation
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided