Inguinal Hernia
Conditions
Keywords
inguinal hernia, laparoscopic repair, open repair, randomized
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.
Interventions
PROCEDUREHernia repair
Hernia repair laparoscopically (LH) or by open operation (OH)
Sponsors
Hospital for Children and Adolescents, Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
4 Months to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recovery after inguinal hernia surgery = time to restore normal activities after surgery | one week |
Secondary
| Measure | Time frame |
|---|---|
| degree of postoperative pain | 3 days |
| duration of surgery and hospital stay | 1 day |
| long term surgical result | 2 years |
Countries
Finland
Outcome results
None listed