Trocar Site Incisional Hernia Prevention

Launched by HOSPITAL UNIVERSITARI JOAN XXIII DE TARRAGONA. · Jan 6, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at ways to prevent incisional hernias, which are bulges that can occur at the site of surgical cuts, after laparoscopic surgery (a type of minimally invasive surgery). Specifically, the study will compare two methods of closing the umbilical trocar site (the small cut made for inserting instruments during surgery): one method uses a special mesh to reinforce the area, while the other uses a standard closure device. Participants will be adult patients scheduled for elective laparoscopic gallbladder removal surgery and will be randomly assigned to one of the two groups. An ultrasound will be done 12 months after surgery to check for any hernias that may have developed.

To be eligible for this trial, participants must be adults undergoing the surgery at the hospital, and they should be in good health (not classified as very ill by the American Society of Anesthesiologists). Unfortunately, those who have allergies to the mesh materials, existing hernias, or are undergoing emergency surgery won't be able to participate. This study is important because it aims to find better ways to reduce the risk of hernias after surgery, which can affect about 30% of patients. Participants can expect to receive follow-up care and monitoring to ensure their health and safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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