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

NCT00716768 | Completed

• 1 other identifier: NA_00010962
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Inguinal Hernia

Keywords

Laparoscopic; Inguinal Hernia; Infants

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable will be total dose of acetaminophen administered for pain management.

  2 years

Secondary Outcomes (1)

• Incidence of intraoperative complications: compromise of testicular vessels, perforation of abdominal viscera.

  2 years

Study Arms (2)

Laparoscopic Inguinal Hernia Repair

ACTIVE COMPARATOR

Procedure: Laparoscopic Inguinal Hernia Repair

Open Inguinal Hernia Repair

ACTIVE COMPARATOR

Procedure: Open Inguinal Hernia Repair

Interventions

Laparoscopic Inguinal Hernia Repair PROCEDURE

Laparoscopic Inguinal Hernia Repair

Laparoscopic Inguinal Hernia Repair

Open Inguinal Hernia Repair PROCEDURE

Open Inguinal Hernia Repair

Open Inguinal Hernia Repair

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Concomitant need for other intraabdominal procedure
• Prior inguinal hernia repair procedure
• 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)
• Liver Disease or contraindication to Tylenol, Midazolam, Fentanyl, or Marcaine.
• Irreducible inguinal hernia, as determined in the operating room prior to randomization and incision.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Johns Hopkins University: collaborator

Study Sites (2)

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fizan Abdullah, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (2)