Status:
RECRUITING
Trocar Site Incisional Hernia Prevention
Lead Sponsor:
Hospital Universitari Joan XXIII de Tarragona.
Collaborating Sponsors:
Institut de Diagnostic per la Imatge
Institut Investigacio Sanitaria Pere Virgili
Conditions:
Incisional Hernia
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after l...
Detailed Description
OBJECTIVE To test the preventive effect of the placement of an onlay mesh at the time of umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery. The estimated ...
Eligibility Criteria
Inclusion
- Patients undergoing elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct, undergoing surgery in our hospital
- ASA (American Society of Anesthesiologists) \<IV
Exclusion
- Allergy or intolerance to any of the mesh components
- Patients presenting already primary or incisional hernia of the abdominal wall
- ASA ≥IV
- Intraoperative conversion to laparotomy
- Emergency surgery
- Pregnancy
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04699201
Start Date
March 2 2021
End Date
February 1 2025
Last Update
October 2 2024
Active Locations (2)
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1
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Tarragona, Spain, 43005
2
Pius, Hospital de Valls
Valls, Tarragona, Spain, 43800