Inguinal HerniaNCT07915830
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
A study testing Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) and Laparoscopic Intracorporeal Suture (LIS) in people with Inguinal Hernia, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial summary
The purpose of this randomized controlled trial is to compare the outcomes of two laparoscopic techniques for repairing inguinal hernia in children: laparoscopic percutaneous extraperitoneal closure (LPEC) and laparoscopic intracorporeal suture (LIS). Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) and Laparoscopic Intracorporeal Suture (LIS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 sitePakistan
- Study dates
- 12 May 2026to 11 Nov 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- unilateral or bilateral inguinal hernia
- planned to undergo laparoscopic hernia repair
Who cannot join
- recurrent hernia
- hernia after previous abdominal surgery
- incarcerated hernia
- coagulopathy
- Associated undescended testes
- Major congenital abdominal anomalies
- Children with congenital heart disease
- Cerebral palsy.
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
Qauad-e-Azam Medical College
Bahawalpur, Punjab Province, 63100
Fatima A Principal Investigator, MBBS, +92 321 6381440, iffat.fatima47@gmail.com
Muhammad R Professor, FCPS, +92 333 6387466, mramzanbhutta@gmail.com
About this study
Official title: Comparative Study of Laparoscopic Percutaneous Extraperitoneal Closure Versus Laparoscopic Intracorporeal Suture in Pediatric Hernia Repair.
The purpose of this randomized controlled trial is to compare the outcomes of two laparoscopic techniques for repairing inguinal hernia in children: laparoscopic percutaneous extraperitoneal closure (LPEC) and laparoscopic intracorporeal suture (LIS). The study will be conducted in the Department of Pediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, and will enroll children aged 1 to 15 years of either gender who have a unilateral or bilateral inguinal hernia and are planned for laparoscopic repair. Children with recurrent, incarcerated, or previously operated hernias, coagulopathy, undescended testes, major congenital abdominal anomalies, congenital heart disease, or cerebral palsy will be excluded.
Participants will be randomly assigned, using sealed opaque envelopes, to one of two groups. Group A will undergo LPEC, in which the hernia sac is closed extraperitoneally with a needle passed percutaneously around the internal inguinal ring under laparoscopic view. Group B will undergo LIS, in which sutures are placed and tied entirely within the abdominal cavity. All operations will be performed by a single surgical team trained in both techniques.
Read more
The main outcome is hernia recurrence at 3 months. Secondary outcomes are operating time, post-operative pain (FLACC score at 12 hours, assessed by a resident blinded to the technique), hospital stay, wound infection within 30 days, other intra- and post-operative complications, and time to return to full activity. Children will be followed weekly in the outpatient clinic and assessed for recurrence at 3 months.
The study hypothesizes that recurrence at 3 months is higher with the intraperitoneal (LIS) approach than with the extraperitoneal (LPEC) approach.
- Conditions
- Inguinal Hernia
- Being tested
- Laparoscopic Percutaneous Extraperitoneal Closure (LPEC), Laparoscopic Intracorporeal Suture (LIS)
- Keywords
- Pediatric inguinal hernia, Laparoscopic hernia repair, Laparoscopic percutaneous extraperitoneal closure, LPEC, Laparoscopic intracorporeal suture, Hernia recurrence, Postoperative pain, FLACC scale, Children
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Percutaneous Extraperitoneal Closure (LPEC)Procedure or surgery
A laparoscope will be inserted through the umbilicus, and a needle with suture is passed percutaneously around the internal inguinal ring under direct laparoscopic vision. The hernia sac (processus vaginalis) is ligated extraperitoneally without opening the inguinal canal.
Laparoscopic Intracorporeal Suture (LIS)Procedure or surgery
Sutures will be placed and tied entirely within the abdominal cavity under laparoscopic visualization, using needle holders and graspers with instrument knot-tying (square or slip knots).
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) | Experimental | Children with unilateral or bilateral inguinal hernia will undergo laparoscopic hernia repair by the LPEC technique under general anesthesia. Receives: Procedure: Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) |
| Laparoscopic Intracorporeal Suture (LIS) | Active comparator | Children with unilateral or bilateral inguinal hernia will undergo laparoscopic hernia repair by the LIS technique under general anesthesia. Receives: Procedure: Laparoscopic Intracorporeal Suture (LIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
Number and percentage of children with recurrence of inguinal hernia on the operated side, assessed by clinical examination at the outpatient follow-up visit.
Measured: From randomization till three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start12 May 2026
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Arshad, Quaid-e-Azam Medical College
- Investigators
- Muhammad R Professor, FCPS, Study chair, Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915830
- Sponsor's protocol ID
- U1111-1348-8557
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Laparoscopic Percutaneous Extraperitoneal Closure Versus Laparoscopic Intracorporeal Suture in Pediatric Hernia Repair.
- ClinicalTrials.gov ID
- NCT07915830
- Acronym / sponsor ID
- U1111-1348-8557
- Conditions
- Inguinal Hernia
- Keywords
- Pediatric inguinal hernia, Laparoscopic hernia repair, Laparoscopic percutaneous extraperitoneal closure, LPEC, Laparoscopic intracorporeal suture, Hernia recurrence, Postoperative pain, FLACC scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 4 Nov 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 purpose of this randomized controlled trial is to compare the outcomes of two laparoscopic techniques for repairing inguinal hernia in children: laparoscopic percutaneous extraperitoneal closure (LPEC) and laparoscopic intracorporeal suture (LIS). The study will be conducted in the Department of Pediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, and will enroll children aged 1 to 15 years of either gender who have a unilateral or bilateral inguinal hernia and are planned for laparoscopic repair. Children with recurrent, incarcerated, or previously operated hernias, coagulopathy, undescended testes, major congenital abdominal anomalies, congenital heart disease, or cerebral palsy will be excluded.
Participants will be randomly assigned, using sealed opaque envelopes, to one of two groups. Group A will undergo LPEC, in which the hernia sac is closed extraperitoneally with a needle passed percutaneously around the internal inguinal ring under laparoscopic view. Group B will undergo LIS, in which sutures are placed and tied entirely within the abdominal cavity. All operations will be performed by a single surgical team trained in both techniques.
The main outcome is hernia recurrence at 3 months. Secondary outcomes are operating time, post-operative pain (FLACC score at 12 hours, assessed by a resident blinded to the technique), hospital stay, wound infection within 30 days, other intra- and post-operative complications, and time to return to full activity. Children will be followed weekly in the outpatient clinic and assessed for recurrence at 3 months.
The study hypothesizes that recurrence at 3 months is higher with the intraperitoneal (LIS) approach than with the extraperitoneal (LPEC) approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) | Experimental | Procedure: Laparoscopic Percutaneous Extraperitoneal Closure (LPEC)Children with unilateral or bilateral inguinal hernia will undergo laparoscopic hernia repair by the LPEC technique under general anesthesia. |
| Laparoscopic Intracorporeal Suture (LIS) | Active comparator | Procedure: Laparoscopic Intracorporeal Suture (LIS)Children with unilateral or bilateral inguinal hernia will undergo laparoscopic hernia repair by the LIS technique under general anesthesia. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- unilateral or bilateral inguinal hernia
- planned to undergo laparoscopic hernia repair
Key exclusion criteria (8 listed)
- recurrent hernia
- hernia after previous abdominal surgery
- incarcerated hernia
- coagulopathy
- Associated undescended testes
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 |
|---|---|---|
| Laparoscopic Percutaneous Extraperitoneal Closure (LPEC)A laparoscope will be inserted through the umbilicus, and a needle with suture is passed percutaneously around the internal inguinal ring under direct laparoscopic vision. The hernia sac (processus vaginalis) is ligated extraperitoneally without opening the inguinal canal. | Procedure or surgery | Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) |
| Laparoscopic Intracorporeal Suture (LIS)Sutures will be placed and tied entirely within the abdominal cavity under laparoscopic visualization, using needle holders and graspers with instrument knot-tying (square or slip knots). | Procedure or surgery | Laparoscopic Intracorporeal Suture (LIS) |
Primary outcome
Hernia recurrence
Time frame: From randomization till three months after surgery
Number and percentage of children with recurrence of inguinal hernia on the operated side, assessed by clinical examination at the outpatient follow-up visit.
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 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia
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Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
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Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
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Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
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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.
Muhammad R Professor, FCPS study chair
Quaid-e-Azam Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) and Laparoscopic Intracorporeal Suture (LIS) in people with Inguinal Hernia, run by Quaid-e-Azam Medical College 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 8 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 4 Nov 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 Fatima A Principal Investigator, MBBS (+92 321 6381440, iffat.fatima47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence (time frame: From randomization till three months after surgery). 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 4 Nov 2026.