Try our beta test site

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Johns Hopkins University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Fizan Abdullah, MD, PhD, Johns Hopkins University Identifier:
First received: July 14, 2008
Last updated: January 31, 2013
Last verified: January 2013

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.

Condition Intervention
Inguinal Hernia
Procedure: Laparoscopic Inguinal Hernia Repair
Procedure: Open Inguinal Hernia Repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years of Age

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The primary outcome variable will be total dose of acetaminophen administered for pain management. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Incidence of intraoperative complications: compromise of testicular vessels, perforation of abdominal viscera. [ Time Frame: 2 years ]

Estimated Enrollment: 152
Study Start Date: October 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic Inguinal Hernia Repair Procedure: Laparoscopic Inguinal Hernia Repair
Laparoscopic Inguinal Hernia Repair
Active Comparator: Open Inguinal Hernia Repair Procedure: Open Inguinal Hernia Repair
Open Inguinal Hernia Repair


Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00716768

United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Fizan Abdullah, MD, PhD Johns Hopkins University
  More Information

Responsible Party: Fizan Abdullah, MD, PhD, Associate Professor of Surgery, Johns Hopkins University Identifier: NCT00716768     History of Changes
Other Study ID Numbers: NA_00010962 
Study First Received: July 14, 2008
Last Updated: January 31, 2013

Keywords provided by Johns Hopkins University:
Inguinal Hernia

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal processed this record on February 20, 2017