Ancona 1998.
Methods | Patients were randomised by fax. Each centre participating in the study sent a randomisation form by fax to the co‐ordinating centre containing the information required for the patient to be randomised, according to a random number generator table. | |
Participants | 108 low‐risk patients classified as either ASA I or II. Patients were entered into the study with a diagnosis of primary or recurrent hernia. Patients with unilateral were included as well as patients with bilateral hernias. High‐risk patients (ASA III and IV) were not included, nor were pregnant patients or patients younger than 18 years of age. Patients with incarcerated hernias, congenital hernias, massive scrotal or sliding hernias, or with a history of multiple recurrent hernias were also excluded. Additional exclusion criteria were the presence of previous pelvic surgery, coagulation disorders and the presence of other abdominal diseases amenable to surgical treatment that could be performed laparoscopically during the same operation. Patients with a personal preference for one of the two procedures and those who had been referred from their general practitioner to receive a specific type of procedure were not included in the study. | |
Interventions | Laparoscopic versus open mesh inguinal herniorrhaphy. Laparoscopic group: (n=52) repair performed by the TAPP technique. All patients were given general anaesthesia. Open group: (n=56) primary inguinal hernias were repaired according to the technique described by Amid et al. Recurrent inguinal hernia repairs were repaired according to the technique described by Lichtenstein. 53 patients were given local anaesthesia, 1 patient was given general anaesthesia and 2 patients were given epidural anaesthesia. | |
Outcomes | Included data items:
Operation time (minutes)
Intraoperative complications
Conversions
Postoperative pain (day 1)
Postoperative complications
Mortality
Length of hospital stay (hours)
Time to return to work (days)
Hernia recurrence Other data items: Use of analgesia Time to return to sport (days) Theatre costs |
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Notes | There may be a 30 patient overlap with this trial and Parma 1997. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |