Coala Trial Gp 1997.

Methods	Randomisation by telephone, according to a computer‐generated list, in groups of 25 or 50 patients; within each of these groups, the maximal allowable difference in the number of patients assigned to the two treatments was 4. They were stratified according to the hospital and the type of hernia. Analysis by 'intention to treat'
Participants	994 patients over 20 years old, who presented with clinically diagnosed unilateral inguinal hernias (primary hernias or first recurrence) and were scheduled to undergo surgical repair with general anaesthesia were eligible. Exclusion criteria were an additional surgical intervention planned during the hernia repair; a history of extensive lower abdominal surgery, severe local inflammation, or radiotherapy; advanced pregnancy (>12 weeks' gestation); and previous participation in the study (contralateral hernia). Patients who were mentally incompetent or not able to speak Dutch were also excluded.
Interventions	Laparoscopic versus open non‐mesh inguinal herniorrhaphy Laparoscopic group (n=487) A TEP repair was performed. 481 patients had general while 6 had spinal anaesthesia. Open group: (n=507) Conventional anterior repair consisted of a reduction of the hernia, ligation of the hernial sac, if necessary and a reconstruction of the inguinal floor with nonabsorbable sutures, if necessary. A mesh prosthesis was not used unless adequate repair was otherwise not possible. 201 patients had general while 306 had spinal anaesthesia.
Outcomes	Included data items: Operation time (minutes) Conversions Intraoperative complications Length of hospital stay (days) Time to return to normal activity (days) Complications Hernia recurrence Mortality Other data items: Postoperative pain (day 1) Use of analgesia Time to return to work (days) Time to resumption of athletic activities (days) Activities of daily living score
Notes	There are multiple publications for this trial including a formal economic evaluation and learning curve assessment.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate