Comparing open and endoscopic techniques for hernia repair
Comparison of Open and Endoscopic Transversus Abdominis Release for Midline Incisional Ventral Hernia - a Randomized Controlled Trial
NA · City Clinical Hospital No.1 named after N.I. Pirogov · NCT06195332
This study is testing whether a traditional open surgery or a less invasive endoscopic surgery works better for fixing large hernias in people.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | City Clinical Hospital No.1 named after N.I. Pirogov (other) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06195332 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the early and long-term outcomes of two surgical techniques, open transversus abdominis release (TAR) and endoscopic TAR, for repairing large midline incisional ventral hernias. The endoscopic approach combines minimally invasive laparoscopic and extraperitoneal techniques, which have shown advantages in previous studies. This randomized trial is designed to fill the gap in existing literature, as no prior randomized studies have compared these two methods directly. The sample size is based on a pilot study that included 133 patients who underwent hernia repair using these techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with midline incisional hernias measuring between 8 to 12 cm in width, classified as ASA I-III, and eligible for minimally invasive repair.
Not a fit: Patients with primary or lateral hernias, or those who refuse to give informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical approach for repairing large incisional hernias, potentially leading to improved patient outcomes.
How similar studies have performed: Previous retrospective studies have indicated advantages of endoscopic TAR over open TAR, but this is the first randomized trial comparing these approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * midline incisional hernia * defect width from 8 till 12 cm * ASA I-III class * able to give informed consent * elective hernia repair * considered eligible for minimally invasive ventral hernia repair Exclusion Criteria: * primary ventral hernia * lateral hernia with/without midline * refuse to give informed consent
Where this trial is running
Moscow
- Clinical City Hospital #1 named after N.I. Pirogov — Moscow, Russia (RECRUITING)
Study contacts
- Study coordinator: Alexander Sazhin, professor
- Email: sazhin-av@yandex.ru
- Phone: +79163904180
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.
Conditions: Incisional Hernia of Midline of Abdomen, incisional hernia, eTEP, open TAR, endoscopic TAR, transversus abdominis release