MRCmulticentre 1999.
Methods | Randomisation was performed by using a computer generated series of random numbers. The trial coordinator prepared sealed envelopes containing the operation to be performed. The envelopes were opened in the clinical centres. | |
Participants | Interim analysis of 120 patients aged between 46 and 77. Criteria for exclusion from randomisation included patient refused randomisation, surgeon had not completed 10 laparoscopic hernia repairs, patient medically unfit for general anaesthesia, had a previous midline or lower paramedian incision, an incarcerated hernia, an uncorrected coagulation disorder or is pregnant. | |
Interventions | Laparoscopic versus mixed open inguinal herniorrhaphy. Laparoscopic group: (n=60) A TEP technique was used. Open group: (n=60) Patients with unilateral primary hernias had a Lichtenstein whereas those with recurrent or bilateral hernias had an open preperitoneal mesh repair through a transverse lower abdominal incision. General anaesthesia was administered to all patients. | |
Outcomes | Included data items:
Operation time (minutes)
Conversions
Intraoperative complications
Return to usual activities (stratified data)
Sever groin pain (1 year)
Numbness (1 year)
Hernia recurrence Other data items: Return to work (days) Costs |
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Notes | There are 2 publications for this trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |