Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland.
Langenbecks Arch Surg. 2023 Sep 21;408(1):369. doi: 10.1007/s00423-023-03106-w.
The aim of this study was to analyze pain after surgery with the use of self-fixated meshes, which are commonly used as an alternative for sutured mesh in open inguinal hernia repair.
This prospective randomized clinical trial was conducted from November 2018 to March 2021, with a follow-up duration of 12 months. Male patients, aged 18-85, and suitable for day case surgery, were included. The patients received the self-adhesive Adhesix™ mesh or the self-gripping Progrip™ mesh in open inguinal hernia surgery. The primary outcome was the number of additional follow-up visits due to post-operative pain. Secondary outcomes included intensity of pain, quality of life measures, and complications.
Two hundred seventy patients were included in this trial, 132 with Adhesix™ (A group), and 138 with Progrip™ (P-group). All patients' medical records were reviewed 12 months after surgery, and 207 patients (76.2%) completed 12-month follow-up. The number of patients needing additional follow-up visits 3-12 months after surgery were comparable (A group 3/3.0%, P-group 6/5.6%). The numeric rating scale was low at 12 months after surgery (at rest A 0.21, P 0.34, at exercise A 0.78, P 0.90). The incidence of chronic pain, that is moderate or severe pain during exercise, was 5 patients (5.2%) with Adhesix™ and 8 patients (7.4%) with Progrip™ (P = 0.333). Two hernia recurrences (1.0%) were established, one in each group.
At 1 year after hernia surgery, the use of self-gripping and self-adhesive meshes lead to successful pain reduction and quality of life improvement.
com NCT03734224.
本研究旨在分析使用自固定补片（self-fixated meshes）后的疼痛情况，该补片通常作为开放式腹股沟疝修补术中缝合补片的替代物。
这是一项前瞻性随机临床试验，于 2018 年 11 月至 2021 年 3 月进行，随访时间为 12 个月。纳入适合日间手术、年龄在 18-85 岁的男性患者。患者接受自粘 Adhesix™补片或自扣 Progrip™补片的开放式腹股沟疝修补术。主要结局是因术后疼痛而需要额外随访的次数。次要结局包括疼痛强度、生活质量测量和并发症。
本试验共纳入 270 例患者，其中 132 例使用 Adhesix™（A 组），138 例使用 Progrip™（P 组）。所有患者的病历均在术后 12 个月进行了回顾，207 例（76.2%）患者完成了 12 个月的随访。术后 3-12 个月需要额外随访的患者人数相当（A 组 3/3.0%，P 组 6/5.6%）。术后 12 个月时，数字评分量表（numeric rating scale）较低（休息时 A 组 0.21，P 组 0.34，运动时 A 组 0.78，P 组 0.90）。慢性疼痛（即运动时中度或重度疼痛）的发生率为 5 例（5.2%）Adhesix™组和 8 例（7.4%）Progrip™组（P=0.333）。确立了 2 例疝复发（1.0%），每组各 1 例。
疝手术后 1 年，使用自扣和自粘补片可成功减轻疼痛，改善生活质量。
com NCT03734224。
