Comparing three surgical methods to prevent postoperative bulging after open repair of direct groin hernia

INTERVENTION: All participants undergo open minimally invasive preperitoneal repair of a unilateral direct inguinal hernia through a 3–4 cm transverse suprainguinal incision, under spinal anaesthesia unless otherwise indicated. A purpose‐made single‐layer monofilament polypropylene mesh (38 g/m², trimmed to a 14 × 9 cm oval with four memory‐recoil rings of No. 1 polydioxanone suture and a central pocket) is placed in the preperitoneal space, covering the direct, indirect, femoral and obturator orifices. The width of the direct defect is measured after the mesh has been placed. Up to this point the operation is identical in all three arms. Participants are then allocated to one of three arms: Arm 1 (control, n = 25): the stretched transversalis fascia is left untouched. Arm 2 (excision, n = 25): a single polyglactin stitch is passed through the stretched transversalis fascia and tied, and the fascia is then excised. Arm 3 (fixation, n = 25): the stretched transversalis fascia is retracted and fixed to Cooper's ligament with a polyglactin suture. The wound is then closed anatomically in all arms. Cefazolin 1 g is given intravenously 30 minutes before incision; intravenous tramadol is given at 0 and 8 hours postoperatively, and at 16 hours if required; a non‐steroidal anti‐inflammatory drug is prescribed for use as required during the first 10 postoperative days. Allocation was not randomised. Eligible participants were assigned to the three arms sequentially, in rotation according to the order in which they presented to the outpatient clinic, until each arm contained 25 participants. No random sequence or allocation concealment was used. The protocol approved by the ethics committee had specified allocation by sealed envelope, but this was not implemented in practice. Participants are assessed at 1 week and 1 month after surgery. Follow‐up ends at one month for those without a pseudohernia; those with a pseudohernia are reviewed every two weeks until the collection has regressed completely. CONDITION: Primary unilateral direct inguinal hernia ; Digestive System PRIMARY OUTCOME: Pseudohernia, defined as a clinically detectable postoperative bulge at the site of the repair, measured using physical examination by the operating surgeon at 1 week after surgery. Ultrasonography was requested only when physical examination was equivocal. INCLUSION CRITERIA: 1. Male sex 2. Aged 18 years or over 3. Primary unilateral direct inguinal hernia 4. Scheduled for elective repair 5. Written informed consent given The direct nature of the defect was confirmed intraoperatively SECONDARY OUTCOME: Haematoma, cord oedema, scrotal oedema and surgical site infection, each recorded as present or absent, measured using physical examination at 1 week and 1 month after surgery Operating time, measured in minutes from skin incision to completion of wound closure, measured using the operative record at the time of surgery Pain measured using patient report as present or absent at 1 week and 1 month after surgery Pseudohernia measured using physical examination by the operating surgeon at 1 month after surgery Size of the pseudohernia, measured using the maximum diameter of the palpable collection in centimetres by the operating surgeon at physical examination, at 1 week, at 1 month, and every 2 weeks thereafter until complete regression Time to complete regression of the pseudohernia, measured using the number of months from the date of surgery to the first review at which the collection was no longer detectable on physical examination, with reviews every 2 weeks