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Article Abstract
Methods: This prospective, multi-centre RCT was conducted in accordance with the CONSORT guidelines for prospective, parallel group randomised studies. Adult patients undergoing elective laparoscopic surgery at two teaching hospitals in Dublin, Ireland were recruited and assigned to one of three closure methods (sutures (SU), staples (ST) or tissue glue (TG)) with primary outcome being cosmesis and secondary outcomes being closure speed, wound complications, cost effectiveness and sustainability outcomes being assessed by a blinded outcomes assessor.
Results: A total of 147 patients were recruited and randomised with a total of 138 being examined in the final analysis (SU = 48, ST = 63, TG = 27). Patient demographics were similar across all groups for gender, mean age, body mass index and American Society of Anaesthesiologists grade (all p > 0.050). For cosmesis, SU had the lowest overall mean observer (p < 0.001) and patient (p = 0.005) scar scores. Furthermore, when evaluating the breakdown for Observer Scar Score (OSS), SU had the lowest vascularity (p = 0.001), pigmentation (p = 0.006), thickness (p < 0.001), relief (p = 0.003) and pliability (p < 0.001). For patient scar score (PSS), SU had the lowest irregularity (p = 0.035). SU was the most cost-effective (p < 0.001) and had the lowest total produced non-recyclable waste (p < 0.001). ST had the shortest closure time (p < 0.001). Overall, there was a no difference in wound complication rates (SU = 6.3 %, ST = 6.4 %, TG = 18.5 %; p = 0.130).
Conclusion: In conclusion, SU was the most effective method for laparoscopic port site closure with regards to cosmesis, cost-efficiency and surgical sustainability. ST was the marginally quicker method of closure and demonstrated equipoise in terms of complication rate. We advocate for SU as the current 'gold standard' with reduced non-recyclable waste generated and a valuable training opportunity for junior trainees.
Trial Registration: ClinicalTrials.gov Identifier: NCT03843866.
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