Leibl 1995.

Methods	Prospective randomised trial During the period May‐December 1993, 102 participants were allocated according to a randomisation plan to the Shouldice procedure (group A) or the laparoscopic procedure (group B).
Participants	102 participants with unilateral primary inguinal hernias Inclusion criteria Unilateral inguinal hernia (not reaching the scrotum). Exclusion criteria Participants after midline lower abdominal incision as a possible obstacle to a laparoscopic lower abdominal incision, participants with an increased risk of operation according to American Society of Anaesthesiology (ASA; > 2)
Interventions	Both procedures were performed under general anaesthesia (standardised ethrane‐narcosis). Shouldice procedure (48 people) The Shouldice‐reparation was conducted according to a technique reported by Schumpelick. A stat dose of antibiotics was provided for prophylaxis of infections due to implantation of extraneous material. Laparoscopic TAPP procedure (54 people) The laparoscopic intervention was always done in Trendelenberg position for a better exposure of the inguinal region. After siting of the pneumoperitoneum, a 10 mm 30°‐angled optic was inserted via infra‐umbilical access. On both sides of the navel, lateral of the rectus‐edge, a 12 mm‐operation port was inserted each.The operator was placed at the contralateral side, the camera was placed opposite. The preparation was started with a curved peritoneal incision above the hernia localization, which reached from the plica umbilicalis medialis to the spina iliaca. The incised peritoneum was removed from the inguinal region. The indirect hernia sac was always completely isolated from cremaster. After exact anatomic preparation, a 12 x 10 cm polypropylene mesh was inserted subperitoneal with driving under the cremaster, so a tension‐free reconstruction of the inguinal back wall with a complete cover of Hesselbach’s triangle was achieved. The inner inguinal ring was reconstructed and the mesh position was saved with 8‐10 titan clips. Afterwards, the closure of the peritoneal incision was done through a continuous suture.
Outcomes	Postoperative complications (e.g. hematoma), spontaneous micturition, use of painkillers, mobilisation, convalescence (especially duration of disability of work) and recurrence rate.
Notes	Test of statistical significance was done with the Wilcoxon‐test for unpaired samples and with Chi2 test
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participants were divided into groups “according to a randomisation plan”
Allocation concealment (selection bias)	Unclear risk	Not mentioned
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not directly mentioned; In the discussion section, the authors say that the non‐calculable bias of the subjective pain assessment and the prior‐informed expectations of the participants, especially towards the gentle minimal‐invasive method should not be underestimated.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned
Incomplete outcome data (attrition bias) All outcomes	Low risk	Median follow‐up: 16 months (13‐21): One drop out in the laparoscopic group due to death (myocardial infarct)
Selective reporting (reporting bias)	Low risk	Outcomes discussed.
Other bias	Low risk	Not described