Paraumbilical Hernia
Conditions
Brief 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.
Interventions
PROCEDUREExtended 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.
PROCEDURESubcutaneous 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.
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | 4 hours | Operative time will include time from the first incision to approximation of skin by skin stapler. |
| Conversion to Any Other Procedure | 4 hours | 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 | 6 months | 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 | 1 month | 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. |
| Hernial contents | 4 hours | Hernial contents will include fat, omentum or bowel. |
| Divarication of recti | 4 hours | Divarication of recti An inter recti distance more than 2cm will be considered as diastasis of recti. |
| Postoperative pain | 6 month | Postoperative pain Postoperative pain will be assessed by the visual analogue score( 0-10) with zero showing no pain and 10 showing maximum pain. |
| Rescue analgesia | 1 month | Rescue analgesia Rescue analgesia will include injection nalbuphine 3mg given for breakthrough pain. VAS score more than 4 will be considered as breakthrough pain. It will be measured as rescue analgesia given or not. |
| Drain out put | 1 month | Drain output Drain output will include amount and type of fluid (blood, serous, serosanginous,). Drains will be removed when drain out will be less than 25ml over 24h. Drain output more than 100ml will be considered as high drain output and less than 100ml will be considered as low output. Drain out put will be measured as high output or low output. |
Countries
Pakistan
Contacts
CONTACTKashaan Azeem, MBBS
CONTACTAhmed U Qureshi, FCPS
STUDY_CHAIRAhmed U Qureshi, FCPS
King Edward Medical University
Outcome results
None listed