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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Fizan Abdullah, MD, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00716768
First received: July 14, 2008
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of intraoperative complications: compromise of testicular vessels, perforation of abdominal viscera. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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 ClinicalTrials.gov identifier: NCT00716768

Contacts
Contact: Fizan Abdullah, MD, PhD 410.955.1983 fa@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Fizan Abdullah, MD, PhD    410-955-1983    fa@jhmi.edu   
Contact: Misty Grimes    410.955.1983    misty@jhmi.edu   
Principal Investigator: Fizan Abdullah, MD, PhD         
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Jeffrey Lukish, MD    410-955-5210    jlukish1@jhmi.edu   
Principal Investigator: Jeffrey Lukish, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Fizan Abdullah, MD, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Fizan Abdullah, MD, PhD, Associate Professor of Surgery, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00716768     History of Changes
Other Study ID Numbers: NA_00010962
Study First Received: July 14, 2008
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Laparoscopic
Inguinal Hernia
Infants

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 28, 2014