Paraumbilical HerniaNCT07434687
Comparison of Extended Totally Extra-peritoneal Repair (ETEP) and Subcutaneous On-lay Endoscopic Approach (SCOLA) for Para-umbilical Hernia (PUH).
A study testing Extended Totally Extra Peritoneal Repair and Subcutaneous On-Lay Endoscopic Approach in people with Paraumbilical Hernia, run by King Edward Medical University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paraumbilical Hernia
- What is being tested?
- Extended Totally Extra Peritoneal Repair and Subcutaneous On-Lay Endoscopic Approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University/Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Ahmed U Qureshi, FCPS, +923144001410, ahmeduzairq@gmail.com
Kashaan Azeem, MS
About this study
Official title: 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)
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:
Read more
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
- Being tested
- Extended Totally Extra Peritoneal Repair, Subcutaneous On-Lay Endoscopic Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Totally Extra Peritoneal RepairProcedure or surgery
Also called ETEP
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.
Subcutaneous On-Lay Endoscopic ApproachProcedure or surgery
Also called SCOLA
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended Totally Extra Peritoneal Repair | Active comparator | Not described Receives: Procedure: Extended Totally Extra Peritoneal Repair |
| Subcutaneous OnLay endoscopic Approach | Active comparator | Not described Receives: Procedure: Subcutaneous On-Lay Endoscopic Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative time will include time from the first incision to approximation of skin by skin stapler.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Hernial contents
Hernial contents will include fat, omentum or bowel.
Measured: 4 hours
Divarication of recti
Divarication of recti An inter recti distance more than 2cm will be considered as diastasis of recti.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Nov 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraumbilical HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed U Qureshi, FCPS, Study chair, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434687
- Sponsor's protocol ID
- 340/RC/KEMU
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07434687
- Acronym / sponsor ID
- 340/RC/KEMU
- Conditions
- Paraumbilical Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Totally Extra Peritoneal Repair | Active comparator | Procedure: Extended Totally Extra Peritoneal Repair |
| Subcutaneous OnLay endoscopic Approach | Active comparator | Procedure: Subcutaneous On-Lay Endoscopic Approach |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended Totally Extra Peritoneal RepairAlso: ETEPThe 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 or surgery | Extended Totally Extra Peritoneal Repair |
| Subcutaneous On-Lay Endoscopic ApproachAlso: SCOLAThe 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. | Procedure or surgery | Subcutaneous OnLay endoscopic Approach |
Primary outcome
Operative Time
Time frame: 4 hours
Operative time will include time from the first incision to approximation of skin by skin stapler.
Conversion to Any Other Procedure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 hours
Hernial contents will include fat, omentum or bowel.
Divarication of recti
Time frame: 4 hours
Divarication of recti An inter recti distance more than 2cm will be considered as diastasis of recti.
Postoperative pain
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
Related trials for Paraumbilical Hernia
Not yet recruitingObservational study
Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair
Abdominal Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed U Qureshi, FCPS study chair
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Totally Extra Peritoneal Repair and Subcutaneous On-Lay Endoscopic Approach in people with Paraumbilical Hernia, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kashaan Azeem, MBBS (+923488676336, Kashanazeem15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: 4 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.