ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00716768
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Fizan Abdullah, MD, Ann & Robert H Lurie Children's Hospital of Chicago

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.


Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Laparoscopic Inguinal Hernia Repair Procedure: Open Inguinal Hernia Repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years of Age
Study Start Date : October 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716768


Locations
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Johns Hopkins University
Investigators
Principal Investigator: Fizan Abdullah, MD, PhD Johns Hopkins University

Responsible Party: Fizan Abdullah, MD, Associate Professor of Surgery, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT00716768     History of Changes
Other Study ID Numbers: NA_00010962
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by Fizan Abdullah, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
Laparoscopic
Inguinal Hernia
Infants

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