NCT07434687|Recruiting
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Sponsor study identifier
interventional
86
1 country
1
Study Start
November 1, 2023
Actual (reported)Primary Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2023
Actual (reported)November 23, 2025
Actual (reported)February 25, 2026
Actual (reported)August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Operative Time
Operative time will include time from the first incision to approximation of skin by skin stapler.
4 hours
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.
4 hours
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.
6 months
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.
1 month
Hernial contents
Hernial contents will include fat, omentum or bowel.
4 hours
Divarication of recti
Divarication of recti An inter recti distance more than 2cm will be considered as diastasis of recti.
4 hours
Postoperative pain
Postoperative pain Postoperative pain will be assessed by the visual analogue score( 0-10) with zero showing no pain and 10 showing maximum pain.
6 month
Rescue analgesia
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.
1 month
Drain out put
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.
1 month
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.
King Edward Medical University/Mayo Hospital Lahore
Lahore, Punjab Province, 54000, Pakistan
Ahmed U Qureshi, FCPS
King Edward Medical University
First Submitted
November 23, 2025
First Posted
February 25, 2026
Study Start
November 1, 2023
Actual (reported)Primary Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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Study Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 25, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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