Comparing suture techniques to prevent incisional hernias after abdominal surgery
Suture Techniques to Reduce the Incidence of Incisional Hernia After Midline Laparotomy; Long-Term Follow-Up of the STITCH Trial
This study is testing two different stitching methods used during abdominal surgery to see which one better prevents hernias and how it affects patients' quality of life over ten years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 9 sites (Rotterdam, South-Holland and 8 other locations) |
| Trial ID | NCT06066385 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effects of two different fascia closure techniques used during abdominal surgery to prevent incisional hernias. It follows up on patients from a previous trial that compared small bites versus large bites for closing midline incisions. The primary goal is to determine if there is a significant difference in the incidence of incisional hernias between the two groups after 10 years. Additionally, the study will assess quality of life, body image, cosmetic results, and abdominal wall function through questionnaires and physical examinations.
Who should consider this trial
Good fit: Ideal candidates are patients who participated in the original STITCH trial and are still alive.
Not a fit: Patients who opted out of future follow-up studies in the original STITCH trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that significantly reduce the incidence of incisional hernias, enhancing patient outcomes.
How similar studies have performed: Previous studies have shown success with similar approaches in preventing incisional hernias, making this follow-up both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
In order to be eligible to participate in this study, a subject must meet the following criteria: * Available signed informed consent form for the original STITCH trial of the patients who are still alive. * Or if the patients has died, the medical records are reviewed. A potential subject who meets the following criteria will be excluded from participation in this study: - Patients that on the original informed consent form of the STITCH trial, checked the box that they did not want to be approached for future follow-up studies.
Where this trial is running
Rotterdam, South-Holland and 8 other locations
- Erasmus MC — Rotterdam, South-Holland, Netherlands (Recruiting)
- Meander Medical Center — Amersfoort, Netherlands (Recruiting)
- Rijnstate ziekenhuis — Arnhem, Netherlands (Recruiting)
- Red Cross Hospital — Beverwijk, Netherlands (Recruiting)
- Groene Hart Ziekenhuis — Gouda, Netherlands (Recruiting)
- Spaarne Gasthuis — Haarlem, Netherlands (Recruiting)
- Franciscus Gasthuis & Vlietland — Rotterdam, Netherlands (Recruiting)
- Prior Havenziekenhuis patients currently in the Erasmus MC — Rotterdam, Netherlands (Recruiting)
- Elisabeth-TweeSteden Ziekenhuis — Tilburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Pieter J Tanis — Erasmus Medical Center
- Study coordinator: Rudolf van den Berg
- Email: R.vandenBerg.4@Erasmusmc.nl
- Phone: 0107043683
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.