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.
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.
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.
Parallel
Extended Totally Extra Peritoneal Repair
Procedure/SurgeryThe 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.
Subcutaneous On-Lay Endoscopic Approach
Procedure/SurgeryThe 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.
Operative Time
Operative time will include time from the first incision to approximation of skin by skin stapler.
Conversion to Any Other Procedure
If the operating surgeon has to shift the operative technique to IPOM or open hernia repair then this will be considered as conversion to any other procedure.
Seroma Formation
Collection of serous fluid at the operative site after hernia repair surgery within 30 days once the drains placed at the site of surgery would been out.
Surgical Site Infection
If a Patient presents with hyperemia and pus discharge from wound within 30 days of operation requiring opening of wound or change in antibiotics will be labeled as surgical site infection.
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