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

July 14, 2008
January 31, 2013
October 2007
January 2014   (final data collection date for primary outcome measure)
The primary outcome variable will be total dose of acetaminophen administered for pain management. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00716768 on ClinicalTrials.gov Archive Site
Incidence of intraoperative complications: compromise of testicular vessels, perforation of abdominal viscera. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years
Randomized Controlled Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years of Age

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Inguinal Hernia
  • Procedure: Laparoscopic Inguinal Hernia Repair
    Laparoscopic Inguinal Hernia Repair
  • Procedure: Open Inguinal Hernia Repair
    Open Inguinal Hernia Repair
  • Active Comparator: Laparoscopic Inguinal Hernia Repair
    Intervention: Procedure: Laparoscopic Inguinal Hernia Repair
  • Active Comparator: Open Inguinal Hernia Repair
    Intervention: Procedure: Open Inguinal Hernia Repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
June 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
up to 3 Years
Yes
Contact: Fizan Abdullah, MD, PhD 410.955.1983 fa@jhmi.edu
United States
 
NCT00716768
NA_00010962
No
Fizan Abdullah, MD, PhD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Fizan Abdullah, MD, PhD Johns Hopkins University
Johns Hopkins University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP