Trials / Completed
CompletedNCT00597194
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- Hospital for Children and Adolescents, Finland · Academic / Other
- Sex
- All
- Age
- 4 Months – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Hernia repair | Hernia repair laparoscopically (LH) or by open operation (OH) |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2007-01-01
- Completion
- 2007-01-01
- First posted
- 2008-01-17
- Last updated
- 2008-01-17
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT00597194. Inclusion in this directory is not an endorsement.