Clinical trial NCT00597194: Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Official title: Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: inguinal hernia
laparoscopic repair
open repair
randomized
Lead sponsor: Hospital for Children and Adolescents, Finland
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 89
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: recovery after inguinal hernia surgery = time to restore normal activities after surgery
timeFrame: one week
Secondary outcomes:
measure: degree of postoperative pain
timeFrame: 3 days
measure: duration of surgery and hospital stay
timeFrame: 1 day
measure: long term surgical result
timeFrame: 2 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Hospital for Children and Adolescents
Study officials:
affiliation: Hospital for Children and Adolescents,Helsinki,Finland
name: Antti I Koivusalo, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Children and Adolescents,Helsinki,Finland
name: Mikko P Pakarinen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Children and Adolescents,Helsinki,Finland
name: Risto J Rintala, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Children and Adolescents,Helsinki,Finland
name: Christer Holmberg, Professor
role: STUDY_DIRECTOR
References:
citation: Butler RE, Burke R, Schneider JJ, Brar H, Lucha PA Jr. The economic impact of laparoscopic inguinal hernia repair: results of a double-blinded, prospective, randomized trial. Surg Endosc. 2007 Mar;21(3):387-90. doi: 10.1007/s00464-006-9123-6. Epub 2007 Jan 19.
citation: Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
citation: Schier F. Laparoscopic inguinal hernia repair-a prospective personal series of 542 children. J Pediatr Surg. 2006 Jun;41(6):1081-4. doi: 10.1016/j.jpedsurg.2006.02.028.
citation: Koivusalo AI, Korpela R, Wirtavuori K, Piiparinen S, Rintala RJ, Pakarinen MP. A single-blinded, randomized comparison of laparoscopic versus open hernia repair in children. Pediatrics. 2009 Jan;123(1):332-7. doi: 10.1542/peds.2007-3752.