Comparing two techniques for closing wounds after abdominal surgery
A Randomized, Controlled Trial Comparing Wound COmplications in Elective Midline Laparotomies After FAscia Closure Using Two Different Techniques of Running Sutures: COFACTOR-trial
This study is testing a new way to close wounds after abdominal surgery to see if it reduces the chance of developing hernias compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American University of Beirut Medical Center Academic / other |
| Locations | 1 site (Beirut, Beirut) |
| Trial ID | NCT03527433 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of a new closure technique for abdominal surgery wounds compared to the traditional method. It is designed as a randomized, controlled, patient and assessor-blinded trial, focusing on the primary endpoint of incisional hernia occurrence one year post-surgery. The study will be conducted at the American University of Beirut Medical Center, which is a tertiary referral center. Prior to the main trial, a pilot study will assess feasibility, patient adherence, and the reliability of randomization and blinding.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective laparotomy through a midline incision.
Not a fit: Patients undergoing emergency surgery or those with prior midline laparotomy or existing hernias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced wound complications and improved recovery outcomes for patients undergoing abdominal surgery.
How similar studies have performed: Previous studies have shown promising results with similar closure techniques, but this trial aims to provide higher quality evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Signed Informed Consent * Undergoing an elective laparotomy through a midline incision * Undergoing a midline laparoscopic procedure (midline laparoscopic extraction site) Exclusion Criteria: * Emergency surgery * Laparotomy through an incision other than midline * Previous midline laparotomy * Presence of incisional or ventral hernia at time of laparotomy * Incisional hernia repair * Laparotomy surgery during pregnancy
Where this trial is running
Beirut, Beirut
- American University of Beirut Medical Center — Beirut, Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Eman Sbaity, MD — American University of Beirut Medical Center
- Study coordinator: Eman Sbaity, MD
- Email: es25@aub.edu.lb
- Phone: +(961)76-110882
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.