Inguinal Hernia Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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