Does Preoperative Physical Activity Predict Postoperative... | NCT07192978

Studies
Does Preoperative Physical Activity Predict Postoperative Complications After Incisional Hernia Repair ?

NCT07192978

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Sep 25, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Incisional Hernia

Interventions

Not provided

Countries

France

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 9, 2026Estimated

First Submitted Date

Sep 16, 2025

First Submission Date that Met QC Criteria

Sep 23, 2025

First Posted Date

Sep 25, 2025Actual

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

Sep 23, 2025

Last Update Posted Date

Sep 25, 2025Actual

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

Patients with abdominal wall incisional hernia often have numerous comorbidities, making management complex.

To date, no study has described the relationship between preoperative physical activity and the occurrence of complications, particularly severe ones, after incisional hernia repair.

The research hypothesis is that "patient fragility" related to physical inactivity and comorbidities is a poor prognostic factor for the occurrence of complications after incisional hernia repair and a source of more severe complications.

Detailed Description

Not provided

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications according to the Comprehensive Complication Index (CCI)	The Comprehensive Complication Index (CCI) Score takes into account all postoperative complications and allows them to be expressed by a score ranging from 0 (no complications) to 100 (death).	Day 1 postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Adult (≥18 years old)
Subject operated on at the HUS between January 6, 2021 and October 24, 2024
Midline eventration
Placement of a prosthetic reinforcement

Exclusion Criteria

- Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes

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

Adult (≥18 years old) operated on at the HUS between January 6, 2021 and October 24, 2024

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benoit Romain, MD, PhD	Contact	33 3.88.12.89.37		benoit.romain@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de cchirurgie générale & digestive - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided