Comparing two minimally invasive repairs—ETEP versus SCOLA—for para‑umbilical hernia
Official title: Comparison of Extended Totally Extra Peritoneal Repair (ETEP) and Subcutaneous Onlay Endoscopic Approach (SCOLA) for the Treatment of Para Umbilical Hernias (PUH) in Terms of Intraoperative Factors(Operative Time, Hernial Contents, Divarication of Recti, Conversion to Any Other Technique) and Postoperative Complications( Surgical Site Infection, Seroma Formation, Postoperative Pain, Rescue Analgesia, Drain Output)
Run by King Edward Medical University · NCT07434687 · Data updated 2026-11-12
This compares two surgical methods, ETEP and SCOLA, to see which leads to fewer complications and less pain for adults aged 18–65 with para‑umbilical hernias.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | King Edward Medical University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | August 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT07434687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with uncomplicated para‑umbilical hernias, a defect ≤5 cm, and who are fit for elective surgery are the ideal candidates.
✕Probably not a fit
Patients with defects >5 cm, complicated or obstructed hernias, previous midline laparotomy, need for abdominoplasty, or high cardiac risk are excluded and therefore unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–65 with uncomplicated para‑umbilical hernias are randomly assigned to receive either an Extended Totally Extra‑peritoneal (ETEP) repair or a Subcutaneous On‑lay Endoscopic (SCOLA) repair, with surgeons and perioperative teams recording operative time and immediate outcomes. The trial tracks postoperative complications such as infection and seroma, measures pain, and follows recovery during scheduled visits for up to six months. Key exclusion criteria include hernia defects larger than 5 cm, complicated or obstructed hernias, prior midline laparotomy, requirement for abdominoplasty, or intermediate-to-high cardiac risk. Results will compare complication rates, pain scores, and operative metrics between the two groups to determine which technique offers better short‑term recovery.
Why it matters
Potential benefit: If one approach produces fewer complications or less pain, patients could recover faster and need fewer follow‑up procedures or interventions.
How similar studies have gone: Both ETEP and SCOLA have been used safely in surgical series and some comparative reports exist, but high‑quality randomized head‑to‑head trials for para‑umbilical hernias are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults of the age group from 18 to 65 years * Patients of both genders admittes with the diagnosis of para-umbilical Hernias through the outdoor department, documented on clinical examination by a consultant general surgeon. Exclusion Criteria: * Patients with a hernial defect more than 5cm, documented in the perioperative findings * Patients with complicated hernias, including irreducible and obstructed varieties, documented on clinical findings. * Patients who require abdominoplasty, opinion given by the operative surgeon. * Patients with intermediate to high risk of MACE during the surgery, documented on the fitness form filled by the cardiology team. * Patients with previous midline incision or laparotomy, documented on clinical examination.
Where it's running
-
King Edward Medical University/Mayo Hospital Lahore
Lahore, Punjab Province, Pakistan Recruiting
Study contacts
- Study coordinator: Kashaan Azeem, MBBS
- Email: Kashanazeem15@gmail.com
- Phone: +923488676336
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.