NCT07434687

Comparison of Extended Totally Extra-peritoneal Repair (ETEP) and Subcutaneous On-lay Endoscopic Approach (SCOLA) for Para-umbilical Hernia (PUH).

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if one of two surgical techniques works better for treating paraumbilical hernias in adult men and women between 18 and 65 years old. The main questions it aims to answer are: Does one technique lead to fewer complications after surgery, such as infection or fluid buildup (seroma)? Does one technique result in less pain or a shorter operating time? Researchers will compare the ETEP repair group to the SCOLA repair group to see if one method leads to better outcomes for patients. Participants will: Be randomly assigned to receive either the ETEP or SCOLA surgical repair. Have their surgery and recovery tracked by the research team. Attend follow-up visits for up to six months to check for any complications.

Conditions

• Paraumbilical Hernia

Interventions

Type	Name	Description
PROCEDURE	Extended Totally Extra Peritoneal Repair	The eTEP (Extended Totally Extra-Peritoneal) approach is a minimally invasive "keyhole" surgery for repairing hernias like paraumbilical hernias. Its core principle is to access the area behind the abdominal muscles without entering the main abdominal cavity. The surgeon creates a workspace between the muscle and its inner lining. A key step is crossing behind the midline to access both sides of the abdomen. The hernia is pushed back into place, and the inner lining is closed. A standard, low-cost mesh is then placed in this space behind the muscles to reinforce the abdominal wall, where it is held in place by natural pressure. Key advantages include using inexpensive mesh without risky bowel contact, potentially leading to less pain. The main challenges are a steep learning curve and longer initial operating times due to the technically complex dissection in a confined space.
PROCEDURE	Subcutaneous On-Lay Endoscopic Approach	The Subcutaneous Onlay Endoscopic Approach (SCOLA) is a minimally invasive technique for repairing hernias near the belly button. In this approach, the surgeon works in the fatty layer between the skin and the abdominal muscles. After pushing the hernia back into place, the hole in the abdominal wall is stitched closed. A large mesh is then placed in this fatty layer, just in front of the muscles, to act as a strong reinforcement patch. The main benefit is that the mesh never touches the internal organs, eliminating the risk of bowel complications. However, creating this space under the skin carries a significant risk of fluid buildup (seroma), which often requires a temporary drain after surgery.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Pakistan