Maki Jota, Mitoma Tomohiro, Ooba Hikaru, Nakato Hikari, Mishima Sakurako, Tani Kazumasa, Eto Eriko, Yamamoto Dan, Yamamoto Risa, Kai Kenji, Tamada Takashi, Akamatsu Kazuyo, Kawanishi Kunihiro, Masuyama Hisashi
Department of Obstetrics and Gynecology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences (Maki, Mitoma, Ooba, Nakato, Mishima, Tani, Eto, and Masuyama), Kita-ku, Okayama, Japan.
Department of Obstetrics and Gynecology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences (Maki, Mitoma, Ooba, Nakato, Mishima, Tani, Eto, and Masuyama), Kita-ku, Okayama, Japan.
Am J Obstet Gynecol MFM. 2024 Sep;6(9):101431. doi: 10.1016/j.ajogmf.2024.101431. Epub 2024 Jul 16.
The role of barbed sutures in preventing myometrial defects and enhancing postpartum outcomes after cesarean section (C-section) is uncertain.
This study compared clinical and ultrasonographic outcomes of uterine scar defects after C-section with barbed and conventional smooth thread sutures.
This was a multicenter, parallel-group, randomized, controlled clinical trial. Four obstetrics and gynecology departments across three Japanese healthcare regions were included. The participants were women requiring their first cesarean delivery between May 2020 and March 2023. Of the 1211 participants enrolled, 298 underwent C-section and 253 were followed up until July 2023. Participants with singleton pregnancies were randomly assigned (1:1 ratio) to receive either conventional or spiral thread sutures with a double-layer continuous suture. The study period comprised the time of consent to the 6- to 7-month examination. The primary endpoint was the rate of scar niches >2 mm evaluated using transvaginal ultrasonography at 6 to 7 months after surgery. Additional metrics included the total operative time, suture application time, operative blood loss, number of additional sutures required for hemostasis, maternal surgical complications, postoperative infections, surgeon's years of experience, and individual subscale scores.
All data of the 220 participants (barbed suture group: 110; conventional suture group: 110) were available, thus enabling a full analysis set. A comparison of the barbed and conventional suture groups, respectively, revealed the following: niche length, 2.45±1.65 mm (range: 1.0-6.7) vs 3.79±1.84 mm (range: 1.0-11.0) (P<.001); niche depth, 1.78±1.07 mm (range: 1.0-5.7) vs 2.70±1.34 mm (range: 1.0-7.3) (P<.001); residual myometrial thickness (RMT), 8.46±1.74 mm (range: 4.8-13.0) vs 7.07±2.186 mm (range: 2.2-16.2) (P<.001); and niche width, 1.58±2.73 mm (range: 0.0-14.0) vs 2.88±2.36 mm (range: 0.0-11.0) (P<.001), respectively. The barbed suture group exhibited no defects and an RMT <3 mm. Furthermore, the barbed suture group had a lower rate of uterine niches (29.1%; n=32/110) than the conventional suture group (68.2%; n=75/110). Secondary outcomes showed no significant differences in operative times, maternal surgical complications, or postoperative complications.
Double-layer barbed sutures during cesarean delivery may prevent C-section scar defects and postoperative complications. El resumen está disponible en Español al final del artículo.
倒刺缝线在剖宫产术后预防子宫肌层缺损及改善产后结局方面的作用尚不确定。
本研究比较了剖宫产术后使用倒刺缝线与传统光滑缝线时子宫瘢痕缺损的临床和超声检查结果。
这是一项多中心、平行组、随机对照临床试验。纳入了日本三个医疗区域的四个妇产科科室。参与者为2020年5月至2023年3月期间首次行剖宫产的女性。在纳入的1211名参与者中，298例行剖宫产，253名随访至2023年7月。单胎妊娠的参与者被随机分配（1:1比例）接受传统缝线或螺旋缝线双层连续缝合。研究期为从同意参与至术后6至7个月检查的时间段。主要终点是术后6至7个月经阴道超声检查评估的瘢痕凹陷>2 mm的发生率。其他指标包括总手术时间、缝线应用时间、术中失血量、止血所需额外缝线数量、产妇手术并发症、术后感染、外科医生的经验年限以及各个子量表评分。
220名参与者（倒刺缝线组：110名；传统缝线组：110名）的所有数据均可用，因此可以进行完整分析集。分别比较倒刺缝线组和传统缝线组，结果如下：瘢痕凹陷长度，2.45±1.65 mm（范围：1.0 - 6.7） vs 3.79±1.84 mm（范围：1.0 - 11.0）（P <.001）；瘢痕凹陷深度，1.78±1.07 mm（范围：1.0 - 5.7） vs 2.70±1.34 mm（范围：1.0 - 7.3）（P <.001）；残余子宫肌层厚度（RMT），8.46±1.74 mm（范围：4.8 - 13.0） vs 7.07±2.186 mm（范围：2.2 - 16.2）（P <.001）；以及瘢痕凹陷宽度，1.58±2.73 mm（范围：0.0 - 14.0） vs 2.88±2.36 mm（范围：0.0 - 11.0）（P <.001）。倒刺缝线组无缺损且RMT <3 mm。此外，倒刺缝线组的子宫瘢痕凹陷发生率（29.1%；n = 32/110）低于传统缝线组（68.2%；n = 75/110）。次要结局显示手术时间、产妇手术并发症或术后并发症无显著差异。
剖宫产术中使用双层倒刺缝线可能预防剖宫产瘢痕缺损及术后并发症。文章末尾提供了西班牙语摘要。
