Clinical trial NCT00716768: Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years
Official title: Randomized Controlled Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Laparoscopic
Inguinal Hernia
Infants
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2008-07-16
Enrollment: 42
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age less than 3 years (36 months) at the time of surgery
2. Reducible inguinal hernia

Exclusion Criteria:

1. Concomitant need for other intraabdominal procedure
2. Prior inguinal hernia repair procedure
3. Hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)
4. Liver Disease or contraindication to Tylenol, Midazolam, Fentanyl, or Marcaine.
5. Irreducible inguinal hernia, as determined in the operating room prior to randomization and incision.

Primary outcomes:
measure: The primary outcome variable will be total dose of acetaminophen administered for pain management.
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of intraoperative complications: compromise of testicular vessels, perforation of abdominal viscera.
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Fizan Abdullah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: