Wilhelminenspital, Allgemein, Viszeral und Tumorchirurgie, Vienna, Austria.
Sigmund Freud Privat Universität, Med. Fakultät, Vienna, Austria.
Br J Surg. 2022 Aug 16;109(9):839-845. doi: 10.1093/bjs/znac194.
Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material.
A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8 mm every 5 mm, USP 2-0, single thread HR 26 mm needle) or long stitch technique (10 mm every 10 mm, USP 1, double loop, HR 48 mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome.
The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173).
The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov).
在腹部正中切开术后，切口疝仍然是一个常见的问题。本研究比较了使用超长效可吸收弹性缝线材料的短缝线与标准环缝法。
设计了一项前瞻性、多中心、平行组、双盲、随机对照优效性试验，适用于择期手术。通过计算机生成的序列将成年患者随机分配至筋膜缝合采用短缝线（每 5mm 缝 5-8mm，USP 2-0，单丝线 HR 26mm 针）或长缝线技术（每 10mm 缝 10mm，USP 1，双环，HR 48mm 针），缝线材料为聚 4-羟基丁酸酯（Monomax®）。术后 1 年通过超声评估切口疝为主要结局。
试验将 425 例患者随机分配至短缝线组（n=215）或长缝线组（n=210），其中 414 例（97.4%）完成 1 年随访。在短缝线组，筋膜的缝合缝线更多（46（12 个标准差）比 25（7 个标准差）；P<0.001），缝线与伤口长度的比例更高（5.3（2.2 个标准差）比 4.0（1.3 个标准差）；P<0.001）。术后 1 年，短缝线组 210 例中有 7 例（3.3%）和长缝线组 204 例中有 13 例（6.4%）发生切口疝（比值比 1.97，95%置信区间 0.77 至 5.05；P=0.173）。
1 年切口疝的发展率较低，短缝线与长缝线之间在临床方面无显著差异，但统计学上无差异。注册号：NCT01965249（http://www.clinicaltrials.gov）。
