Comparing short stitch and traditional suture techniques after liver surgery
Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial
This study is testing whether a new short stitch method for closing the abdomen after liver surgery can help prevent hernias better than the traditional suture technique.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04982653 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two surgical closure techniques, short stitch suture and traditional suture, in preventing incisional hernias following liver tumor surgeries. The primary objective is to determine if the small bites abdominal wall closure reduces the risk of hernia development compared to the conventional method. Secondary objectives include assessing short-term outcomes, hernia rates in different patient subgroups, and the impact on quality of life post-surgery. Patients will be randomized into two groups and followed up for a year to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective hepatectomy due to malignant liver conditions.
Not a fit: Patients with pre-existing abdominal hernias or a history of mesh placement at prior surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of incisional hernias in patients undergoing liver surgery.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promising results in other surgical fields with different closure techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing hepatectomy for malignant diagnosis (primary or secondary) from 5/1/2021 through 11/1/2024 will be eligible for inclusion in this study * Elective surgery * Age \>= 18 * Planned midline laparotomy incision or inverted-L incision Exclusion Criteria: * Pre-existing abdominal hernia * History of mesh placement at prior laparotomy * Pregnant women
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Timothy E Newhook, MD — M.D. Anderson Cancer Center
- Study coordinator: Timothy E Newhook, MD
- Email: TNewhook@mdanderson.org
- Phone: 713-792-6940
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.