Incisional HerniaEVENTESTNCT07192978
Does Preoperative Physical Activity Predict Postoperative Complications After Incisional Hernia Repair ?
An observational study of Incisional Hernia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to 9 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years old) operated on at the HUS between January 6, 2021 and October 24, 2024
Who may be able to join
- 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
Who cannot join
- Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de cchirurgie générale & digestive - CHU de Strasbourg - France
Strasbourg, 67091
Benoit Romain, 33 3.88.12.89.37, benoit.romain@chru-strasbourg.fr
Benoit Romain, MD, PhD
About this study
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.
- Conditions
- Incisional Hernia
- Keywords
- Incisional Hernia, Laparotomy, Comprehensive Complication Index, Clavien-Dindo classification
- Medical subject headings
- Incisional Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start9 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completion9 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192978
- Sponsor's protocol ID
- 9768
- Acronym
- EVENTEST
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preoperative Physical Activity Predict Postoperative Complications After Incisional Hernia Repair ?
- ClinicalTrials.gov ID
- NCT07192978
- Acronym / sponsor ID
- EVENTEST / 9768
- Conditions
- Incisional Hernia
- Keywords
- Incisional Hernia, Laparotomy, Comprehensive Complication Index, Clavien-Dindo classification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 9 Sep 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years old) operated on at the HUS between January 6, 2021 and October 24, 2024
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications according to the Comprehensive Complication Index (CCI)
Time frame: Day 1 postoperatively
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit Romain, MD, PhD (33 3.88.12.89.37, benoit.romain@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications according to the Comprehensive Complication Index (CCI) (time frame: Day 1 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.