Department of Urology, Wake Forest Baptist Health, Winston Salem, North Carolina.
Obstet Gynecol. 2022 Jan 1;139(1):97-106. doi: 10.1097/AOG.0000000000004629.
To compare postoperative gluteal and posterior thigh pain, device performance, and perioperative complications in women undergoing sacrospinous ligament fixation with an anchor-based compared with a suture-capturing device.
This was a single-center, patient-blinded, parallel, superiority trial of patients undergoing native-tissue pelvic organ prolapse repair through sacrospinous ligament fixation with an anchor-based compared with suture-capturing device using randomized-block randomization. The primary outcome was the increase in gluteal and posterior thigh pain from baseline to 1-week postoperation using the numerical rating scale. Pain was also assessed at postoperative day 1, week 6, and a summarized assessment for the first postoperative week. Intraoperative device performance, home opioid pain medication use, and changes in prolapse symptom scores were also analyzed. To provide 80% power to detect a pain difference of 2.5 points between the groups with an SD of 2.8 and a 15% dropout estimate using a two-sided 5% significance level, 24 patients were required per group. Analysis with Student's t test, Wilcoxon rank-sum tests, and Fisher exact tests were performed as well as an analysis of covariance for the primary outcome.
Between September 2018 and June 2020, 47 patients (24 anchor-based and 23 suture-capturing) were included in the study. There was no significant difference between the anchor-based and suture-capture groups in mean change in gluteal and posterior thigh pain from baseline to 1-week postoperation (-0.4, 95% CI -1.6 to 2.3). The highest pain increase from baseline during the first postoperative week was also similar between the two groups (up 4.00 and up 4.74, respectively) with no significant difference between the anchor-based and suture-capture groups (-0.7, 95% CI -1.4 to 2.8). There were no differences in changes in pain at any of the other timepoints, in opioid pain medication utilization, device performance, or in prolapse symptom scores.
An anchor-based device did not reduce postoperative gluteal and posterior thigh pain compared with a suture-based device after sacrospinous ligament fixation.
ClinicalTrials.gov, NCT03565640.
Supported by Neomedic via Adler Instruments. Neomedic provided funding for this principal investigator-initiated study. Funding went to providing small value gift cards to patients for study completion, office supplies for the study, and funding the data analysis collaboration with the Wake Forest Baptist Health CTSI Biostatistics Department. Neomedic did not have any direct role in study design, patient recruitment, study execution, data analysis, or manuscript writing or editing.
比较经骶棘韧带固定术采用锚定式与缝线捕捉式装置治疗女性患者术后臀腿疼痛、器械性能和围手术期并发症。
这是一项单中心、患者盲法、平行、优效性试验，纳入接受经骶棘韧带固定术治疗的患者，比较采用锚定式与缝线捕捉式装置治疗的患者术后臀腿疼痛、器械性能、围手术期并发症。主要结局是采用数字评分量表（NRS）评估患者术后 1 周内臀腿疼痛的增加程度。术后第 1 天、第 6 天和术后第 1 周进行疼痛评估。还分析了术中器械性能、家庭用阿片类止痛药使用情况和脱垂症状评分的变化。采用双侧 5%显著性水平和 15%失访率估计值，每组需要 24 例患者，以 80%的效能检测组间疼痛差异 2.5 分，组间 SD 为 2.8。采用 Student's t 检验、Wilcoxon 秩和检验、Fisher 确切概率检验以及协方差分析进行分析。
2018 年 9 月至 2020 年 6 月，共纳入 47 例患者（锚定式 24 例，缝线捕捉式 23 例）。锚定式组与缝线捕捉式组基线至术后 1 周时臀腿疼痛的平均变化值无显著差异（-0.4，95%CI -1.6 至 2.3）。两组在术后第 1 周内的最高疼痛增加值也相似（分别增加 4.00 和 4.74），组间无显著差异（-0.7，95%CI -1.4 至 2.8）。其他各时间点的疼痛变化、阿片类止痛药使用、器械性能或脱垂症状评分均无差异。
与缝线固定装置相比，经骶棘韧带固定术后，锚定式装置并未降低臀腿疼痛。
ClinicalTrials.gov，NCT03565640。
由 Neomedic 通过 Adler Instruments 提供支持。Neomedic 为这项由主要研究者发起的研究提供了资金。资金用于向患者提供完成研究的小价值礼品卡、研究用办公用品以及与维克森林浸信会健康 CTSI 生物统计学部门的数据分析合作提供资金。Neomedic 对研究设计、患者招募、研究执行、数据分析或手稿撰写或编辑没有任何直接作用。
