Preventing incisional hernias after laparoscopic surgery
Prevenció De L'Hèrnia Incisional Per Tròcar
This study is testing whether using a special mesh during laparoscopic surgery can help prevent hernias from forming at the surgery site compared to the usual stitching method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Hospital Universitari Joan XXIII de Tarragona. Academic / other |
| Locations | 2 sites (Tarragona, Tarragona and 1 other locations) |
| Trial ID | NCT04699201 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of using an onlay mesh compared to standard fascial closure techniques at the umbilical trocar site to prevent incisional hernias following laparoscopic cholecystectomy. Adult participants will be randomly assigned to either the mesh group or the control group, with abdominal ultrasound scans performed at 12 months post-surgery to assess for hernia formation. The study is designed to address the high prevalence of incisional hernias, which can occur in up to 30% of patients after laparoscopic procedures. By utilizing imaging techniques, the trial seeks to provide more accurate results regarding hernia detection.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective laparoscopic cholecystectomy without significant comorbidities.
Not a fit: Patients with existing hernias, severe comorbidities, or those undergoing emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of incisional hernias in patients undergoing laparoscopic surgery.
How similar studies have performed: While there are few studies on incisional hernia prevention, this trial employs a novel approach with imaging techniques that have not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tarragona, Tarragona and 1 other locations
- Hospital Universitari de Tarragona Joan XXIII — Tarragona, Tarragona, Spain (Recruiting)
- Pius, Hospital de Valls — Valls, Tarragona, Spain (Recruiting)
Study contacts
- Study coordinator: Joan Ferreres Serafini, MD
- Email: joanfs8@gmail.com
- Phone: (+34) 657920793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.