NCT07229703

Brief Summary

The goal of this observational study is to learn about the long-term effects of repair of burst abdomen by both primary repair and component separation. The main question it aims to answer is: Does component separation lower postoperative complications ?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

January 1, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

6 years

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Burst Abdomen

Keywords

tension sutureburst abdomen

Outcome Measures

Primary Outcomes (1)

  • wound infection

    30 days

Secondary Outcomes (1)

  • incisional hernia

    5 years

Study Arms (2)

component separation

management of burst abdomen by component separation

Procedure: component separation

primary repair

primary repair of burst abdomen

Procedure: primary repair for burst abdomen

Interventions

component separationPROCEDURE

component separation for management of burst abdomen

component separation
primary repair for burst abdomenPROCEDURE

management of burst abdomen by primary repair

primary repair

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\> 18 years with BA

You may qualify if:

  • adult patients (≥18 years) underwent PCS+TAR+MA or primary suture with tension sutures for complete burst abdomen

You may not qualify if:

  • \. BA grade 1B, 2, 3, and 4 (n=17),
  • \< 18 years (n=2)
  • Primary laparotomy performed through a non-midline incision (n=4)
  • Open abdomen (n=5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

January 1, 2014

Primary Completion

January 1, 2020

Study Completion

September 1, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share