Hawaii 1994.
Methods | Randomisation was provided by an independent computer consultant using a table of random numbers. The nurse co‐ordinator prepared sequentially numbered, sealed envelopes containing the operation to be performed. The surgeon was unaware of the sequence of procedures. An envelope was opened by the patient during the clinic visit prior to surgery. | |
Participants | 100 patients between 20 and 70 years of age who were referred with symptomatic inguinal hernias and were suitable for general anaesthesia and able to tolerate a pneumoperitoneum. Direct, indirect, recurrent and bilateral hernias were acceptable for inclusion. Patients with paediatric, femoral or incarcerated hernias were excluded. The prior removal of a non perforated appendix was acceptable, but any other lower abdominal surgery excluded the patient from participation. | |
Interventions | Laparoscopic versus open mesh inguinal herniorrhaphy. Laparoscopic group: (n=48) repair performed by the TAPP technique. Open group: (n=52) repairs performed in a tension‐free manner similar to that described by Lichtenstein. Most of the procedures were performed using local anaesthetic with sedation. Spinal anaesthesia used in two cases and general anaesthesia in 3 cases | |
Outcomes | Included data items:
Operation time (minutes)
Conversions
Discharge time (hours)
Time to return to work (days)
Complications
Pain persisting longer than 3 months
Hernia recurrence
Time to return to work (days: stratified data) Other data items: 'Straight leg raises' performance Hospital costs |
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Notes | Published abstract and full text available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |