Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis? (Drain-IHR)

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 Overview

• Status: Recruiting
• Conditions: Eventration of the Abdominal Wall

• Study Type: Observational
• Enrollment (Anticipated): 113

Contacts and Locations

• Study Contact: Name: Benoit ROMAIN, MD, PhD; Phone Number: 33 3 88 12 72 37; Email: benoit.romain@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de chirurgie générale et digestive - CHU de Strasbourg - France
    • Contact: Benoit ROMAIN, MD, PhD; Phone Number: 33 3 88 12 72 37; Email: benoit.romain@chru-strasbourg.fr
    • Principal Investigator: Benoit Romain, MD, PhD
    • Sub-Investigator: Samer DIAB, MD
    • Sub-Investigator: Vincent LOUIS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patient (≥18 years old) operated on at HUS between 01/01/2018 and 12/31/2020

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
infection after drainage in contact with a retromuscular prosthesis	1 day after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2022
• Primary Completion (Anticipated): September 10, 2022
• Study Completion (Anticipated): September 10, 2022

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Drainage; Hernia; Digestive surgery; Eventration of the abdominal wall; Retromuscular position
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Musculoskeletal Abnormalities; Hernia; Gastroschisis
• Other Study ID Numbers: 8704

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No