Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

This study has been completed.
Sponsor:
Information provided by:
Hospital for Children and Adolescents, Finland
ClinicalTrials.gov Identifier:
NCT00597194
First received: January 8, 2008
Last updated: January 16, 2008
Last verified: December 2007
  Purpose

We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.


Condition Intervention
Inguinal Hernia
Procedure: 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: Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

Resource links provided by NLM:


Further study details as provided by Hospital for Children and Adolescents, Finland:

Primary Outcome Measures:
  • recovery after inguinal hernia surgery = time to restore normal activities after surgery [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • degree of postoperative pain [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • duration of surgery and hospital stay [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • long term surgical result [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: October 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OH
Inguinal hernia operated using a classic open herniotomy(OH)
Procedure: Hernia repair
Hernia repair laparoscopically (LH) or by open operation (OH)
Active Comparator: LH
Laparoscopic herniorraphy (LH) for inguinal hernia
Procedure: Hernia repair
Hernia repair laparoscopically (LH) or by open operation (OH)

Detailed Description:

Background and objective : In adults the advantages laparoscopic inguinal hernia are less pain, shorter recovery, shorter sick leave and better cosmetic result. It is not known whether laparoscopic hernia repair produces similar results in children.The objective is to compare the duration of recovery, postoperative pain and long-term surgical results between day case laparoscopic and open inguinal hernia repair in children.

Key inclusion criteria: Children included in the study must be aged four months to sixteen years of age and not have undergone any previous surgery. Of male patients those with completely descended testes are accepted.

Study type: The study is randomized, single-blinded prospective comparison between laparoscopic and open day case inguinal hernia repair in children.

Target sample size: For the assumption that there is a difference of one day in time to restore normal activities after laparoscopic and open hernia repair, target sample size of 100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p < 0.05.

Recruitment status : From 10/ 2002 to 1/2007 89 patients (laparoscopic repair LH 47, open repair OH 42) are recruited. Primary outcome: The time to restore normal activity after surgery . Secondary Outcomes : The degree of postoperative pain, the duration of the operation, sick leave of parents, surgical result 6 months and 2 years after the repair.

  Eligibility

Ages Eligible for Study:   4 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral inguinal hernia
  • age age > 4 months, <16 years
  • fully descended testes
  • study consent signed

Exclusion Criteria:

  • previous abdominal or inguinal surgery
  • testes not fully descended
  • not healthy enough for day surgery
  • age < 4months or >16 years
  • study consent not signed
  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: NCT00597194

Locations
Finland
Hospital for Children and Adolescents
Helsinki, Finland, 000290
Sponsors and Collaborators
Hospital for Children and Adolescents, Finland
Investigators
Principal Investigator: Antti I Koivusalo, MDPhD Hospital for Children and Adolescents,Helsinki,Finland
Principal Investigator: Mikko P Pakarinen, MD PhD Hospital for Children and Adolescents,Helsinki,Finland
Principal Investigator: Risto J Rintala, Professor Hospital for Children and Adolescents,Helsinki,Finland
Study Director: Christer Holmberg, Professor Hospital for Children and Adolescents,Helsinki,Finland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Christer Holmberg, Hospital for Children and Adolescents, Helsinki, Finland
ClinicalTrials.gov Identifier: NCT00597194     History of Changes
Other Study ID Numbers: 216L2002, T 1040L0007
Study First Received: January 8, 2008
Last Updated: January 16, 2008
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Hospital for Children and Adolescents, Finland:
inguinal hernia
laparoscopic repair
open repair
randomized

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

ClinicalTrials.gov processed this record on October 20, 2014