Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years

Laparoscopic techniques have been applied widely to the management of various common
pediatric surgical diseases. Current evidence lacks sufficient quality to justify the
widespread adoption of the laparoscopic approach to the repair of inguinal hernias within
children. It is important to critically evaluate the efficiency and the potential risks of
these new techniques before they can supplant open techniques as the treatment modality of
choice. Numerous large case series of laparoscopic inguinal hernia repair have been reported
with average length of stay, complication rates, recurrence rates and pain management scores
that mirror those of open inguinal hernia repair. Only one randomized controlled trial has
been performed to compare the open versus laparoscopic technique which has not provided
answers regarding the potential benefits on young infants. Benefits of an open approach in
children includes a shorter operative time, while the laparoscopic procedure is associated
with less pain and a better cosmetic result.

This study will compare open versus laparoscopic repairs of inguinal hernias. The primary
outcome variable will be total dose of acetaminophen administered postoperatively for pain
management. Secondary outcome variables include 1) Incidence of intraoperative complications
such as compromise of testicular vessels, perforation of abdominal viscera; 2) Short-term
outcomes such as operative time, rate of conversion from open to laparoscopic procedure,
requirement for reoperation within 30 days, wound infection, acute hydroceles and
post-operative length of stay; 3) Long-term outcomes such as recurrent inguinal hernia,
testicular atrophy and; 4) Cost of hospitalization will be compared between the open and
laparoscopic groups.

Comparisons will be made in two groups of patients- patients with 1) unilateral hernias and
2) bilateral hernias and will last for 2 years. 102 patients in the unilateral arm and 50
patients in the bilateral arm will be randomized to each treatment group and each subject
will be followed for up to 12 months following the surgical intervention. Two study
evaluations by telephone (in addition to a single outpatient clinic visit already required as
part of standard post-operative care) will be required of each research subject and his/her
parent/guardian. The telephone evaluations will occur at 3 and 12 months following surgery.
The standard post-operative clinic visit is scheduled at 2 weeks following surgery.