Comparing two minimally invasive repairs—ETEP versus SCOLA—for para‑umbilical hernia
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)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | King Edward Medical University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07434687 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lahore, Punjab Province
- 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
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.