An interventional study of Laparoscopic Percutaneous Extraperitoneal Closure (LPEC) and Laparoscopic Intracorporeal Suture (LIS) in Inguinal Hernia, sponsored by Quaid-e-Azam Medical College. Recruiting at 1 site in Pakistan. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Quaid-e-Azam Medical College · Not applicable, Interventional, and Treatment
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.
567 studies on the registry are indexed under Hernia, Inguinal; 80 are open to participants now.
This study's planned enrollment of 412 is above the median of 90 across 420 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Quaid-e-Azam Medical College is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Children with unilateral or bilateral inguinal hernia will undergo laparoscopic hernia repair by the LPEC technique under general anesthesia.
Procedure: Laparoscopic Percutaneous Extraperitoneal Closure (LPEC)
Children with unilateral or bilateral inguinal hernia will undergo laparoscopic hernia repair by the LIS technique under general anesthesia.
Procedure: Laparoscopic Intracorporeal Suture (LIS)
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.
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).
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.
Time frame: From randomization till three months after surgery
Operating time
Time in minutes from skin incision to wound closure, recorded by the operation theater nurse in-charge using a stopwatch.
Time frame: From skin incision to wound closure on the day of surgery
Post-operative pain
Pain score on the FLACC scale (Face, Legs, Activity, Cry, Consolability; range 0 to 10, higher scores indicating more pain), assessed every 2 hours after surgery by a resident blinded to the surgical technique. The final score at 12 hours is used for analysis.
Time frame: From skin closure to 12 hours after postoperatively
Duration of hospital stay
Number of days from the day of surgery to the day of discharge. Children are discharged when pain free and mobile, as per hospital protocol.
Time frame: From the day of surgery to discharge within 1 to 3 days
Surgical wound infection
Number and percentage of children with surgical site infection, defined as signs of inflammation (fever, pain, redness), purulent discharge, or an organism identified from an aseptically obtained specimen from the surgical site.
Time frame: From wound closure to Within 30 days after surgery
Time to return to full activity
Time in days taken to return to all previously performed activities, recorded at weekly outpatient follow-up visits.
Time frame: From wound closure up to 3 months after surgery
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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