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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

January 8, 2008
January 16, 2008
October 2002
January 2007   (final data collection date for primary outcome measure)
recovery after inguinal hernia surgery = time to restore normal activities after surgery [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00597194 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Inguinal Hernia
Procedure: Hernia repair
Hernia repair laparoscopically (LH) or by open operation (OH)
  • Active Comparator: OH
    Inguinal hernia operated using a classic open herniotomy(OH)
    Intervention: Procedure: Hernia repair
  • Active Comparator: LH
    Laparoscopic herniorraphy (LH) for inguinal hernia
    Intervention: Procedure: Hernia repair

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
4 Months to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00597194
216L2002, T 1040L0007
No
Professor Christer Holmberg, Hospital for Children and Adolescents, Helsinki, Finland
Hospital for Children and Adolescents, Finland
Not Provided
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
Hospital for Children and Adolescents, Finland
December 2007

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