Eventration of the Abdominal WallDrain-IHRNCT05534503
Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?
An observational study of Eventration of the Abdominal Wall, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eventration of the Abdominal Wall
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2022to 10 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Adult patient (≥18 years old) operated on at HUS between 01/01/2018 and 12/31/2020
Who may be able to join
- Adult patient (≥18 years old)
- Patient operated on at HUS between 01/01/2018 and 12/31/2020
- Patient who has undergone surgical cure of anterior or lateral abdominal wall eventration of any width with placement during the procedure of a prosthetic mesh in a prefascial retromuscular position.
- Patient not objecting to the reuse of their data for scientific research purposes.
Who cannot join
- Patient who has expressed opposition to the reuse of his or her data for scientific research purposes.
- Particular clinical forms of the disease: absence of previous surgical intervention (and thus absence of ventration: umbilical hernia, diastasis)
- Absence of prosthesis during the operation or prosthesis placed in intraperitoneal position
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de chirurgie générale et digestive - CHU de Strasbourg - France
Strasbourg, 67091
Benoit ROMAIN, MD, PhD, 33 3 88 12 72 37, benoit.romain@chru-strasbourg.fr
Benoit ROMAIN, MD, PhD
About this study
Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.
- Conditions
- Eventration of the Abdominal Wall
- Keywords
- Eventration of the abdominal wall, Hernia, Drainage, Retromuscular position, Digestive surgery
- Medical subject headings
- Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
infection after drainage in contact with a retromuscular prosthesis
Measured: 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start31 Jul 2022
- Primary completion10 Sep 2022 (estimated)
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eventration of the Abdominal WallStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 113 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
- NCT05534503
- Sponsor's protocol ID
- 8704
- Acronym
- Drain-IHR
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 10 Sep 2022
- 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 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?
- ClinicalTrials.gov ID
- NCT05534503
- Acronym / sponsor ID
- Drain-IHR / 8704
- Conditions
- Eventration of the Abdominal Wall
- Keywords
- Eventration of the abdominal wall, Hernia, Drainage, Retromuscular position, Digestive surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 9 Sep 2022 (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.
Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) operated on at HUS between 01/01/2018 and 12/31/2020
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old)
- Patient operated on at HUS between 01/01/2018 and 12/31/2020
- Patient who has undergone surgical cure of anterior or lateral abdominal wall eventration of any width with placement during the procedure of a prosthetic mesh in a prefascial retromuscular position.
- Patient not objecting to the reuse of their data for scientific research purposes.
Key exclusion criteria (3 listed)
- Patient who has expressed opposition to the reuse of his or her data for scientific research purposes.
- Particular clinical forms of the disease: absence of previous surgical intervention (and thus absence of ventration: umbilical hernia, diastasis)
- Absence of prosthesis during the operation or prosthesis placed in intraperitoneal position
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
infection after drainage in contact with a retromuscular prosthesis
Time frame: 1 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
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. This study is not recruiting at the moment.
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 Eventration of the Abdominal Wall, 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 3 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: status not confirmed, as of the sponsor's last update on 10 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoit ROMAIN, MD, PhD (33 3 88 12 72 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?
infection after drainage in contact with a retromuscular prosthesis (time frame: 1 day after surgery). 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 10 Sep 2022.