NCT07915830 Comparing Two Laparoscopic Techniques for Hernia Repair in Children
| NCT ID | NCT07915830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Quaid-e-Azam Medical College |
| Condition | Inguinal Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 412 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2026-11-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 412 participants in total. It began in 2026-05-12 with a primary completion date of 2026-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: * unilateral or bilateral inguinal hernia * planned to undergo laparoscopic hernia repair Exclusion Criteria: * recurrent hernia * hernia after previous abdominal surgery * incarcerated hernia * coagulopathy * Associated undescended testes * Major congenital abdominal anomalies * Children with congenital heart disease * Cerebral palsy.
Contact & Investigator
Muhammad R Professor, FCPS
STUDY CHAIR
Quaid-e-Azam Medical College
Frequently Asked Questions
Who can join the NCT07915830 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 15 Years, studying Inguinal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07915830 currently recruiting?
Yes, NCT07915830 is actively recruiting participants. Contact the research team at iffat.fatima47@gmail.com for enrollment information.
Where is the NCT07915830 trial being conducted?
This trial is being conducted at Bahawalpur, Pakistan.
Who is sponsoring the NCT07915830 clinical trial?
NCT07915830 is sponsored by Quaid-e-Azam Medical College. The principal investigator is Muhammad R Professor, FCPS at Quaid-e-Azam Medical College. The trial plans to enroll 412 participants.