- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00597194
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Helsinki, Finland, 000290
- Hospital for Children and Adolescents
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: OH
Inguinal hernia operated using a classic open herniotomy(OH)
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Hernia repair laparoscopically (LH) or by open operation (OH)
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Active Comparator: LH
Laparoscopic herniorraphy (LH) for inguinal hernia
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Hernia repair laparoscopically (LH) or by open operation (OH)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
recovery after inguinal hernia surgery = time to restore normal activities after surgery
Time Frame: one week
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one week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
degree of postoperative pain
Time Frame: 3 days
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3 days
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duration of surgery and hospital stay
Time Frame: 1 day
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1 day
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long term surgical result
Time Frame: 2 years
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2 years
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Collaborators and Investigators
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 216L2002
- T 1040L0007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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