Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia, laparoscopic repair, open repair, randomized
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
Sites / Locations
- Hospital for Children and Adolescents
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
OH
LH
Arm Description
Inguinal hernia operated using a classic open herniotomy(OH)
Laparoscopic herniorraphy (LH) for inguinal hernia
Outcomes
Primary Outcome Measures
recovery after inguinal hernia surgery = time to restore normal activities after surgery
Secondary Outcome Measures
degree of postoperative pain
duration of surgery and hospital stay
long term surgical result
Full Information
NCT ID
NCT00597194
First Posted
January 8, 2008
Last Updated
January 16, 2008
Sponsor
Hospital for Children and Adolescents, Finland
1. Study Identification
Unique Protocol Identification Number
NCT00597194
Brief Title
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
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital for Children and Adolescents, Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia, laparoscopic repair, open repair, randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OH
Arm Type
Active Comparator
Arm Description
Inguinal hernia operated using a classic open herniotomy(OH)
Arm Title
LH
Arm Type
Active Comparator
Arm Description
Laparoscopic herniorraphy (LH) for inguinal hernia
Intervention Type
Procedure
Intervention Name(s)
Hernia repair
Intervention Description
Hernia repair laparoscopically (LH) or by open operation (OH)
Primary Outcome Measure Information:
Title
recovery after inguinal hernia surgery = time to restore normal activities after surgery
Time Frame
one week
Secondary Outcome Measure Information:
Title
degree of postoperative pain
Time Frame
3 days
Title
duration of surgery and hospital stay
Time Frame
1 day
Title
long term surgical result
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antti I Koivusalo, MDPhD
Organizational Affiliation
Hospital for Children and Adolescents,Helsinki,Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mikko P Pakarinen, MD PhD
Organizational Affiliation
Hospital for Children and Adolescents,Helsinki,Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Risto J Rintala, Professor
Organizational Affiliation
Hospital for Children and Adolescents,Helsinki,Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christer Holmberg, Professor
Organizational Affiliation
Hospital for Children and Adolescents,Helsinki,Finland
Official's Role
Study Director
Facility Information:
Facility Name
Hospital for Children and Adolescents
City
Helsinki
ZIP/Postal Code
000290
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17235721
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.
Results Reference
background
PubMed Identifier
16862612
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.
Results Reference
background
PubMed Identifier
16769338
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.
Results Reference
background
PubMed Identifier
19117900
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.
Results Reference
derived
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Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
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