Ribaric G, D'Hoore A, Schiffhorst G, Hempel E
Clinical and Medical Affairs, Ethicon Endo-Surgery (Europe) GmbH, European Surgical Institute, Norderstedt/Hamburg, Germany,
Int J Colorectal Dis. 2014 May;29(5):611-22. doi: 10.1007/s00384-014-1836-8. Epub 2014 Feb 21.
Stapled transanal rectal resection (STARR) in patients with obstructive defecation syndrome (ODS) is limited by the capacity of the circular stapler used. This prospective cohort study was conducted to assess real-world clinical outcomes of STARR with the new CONTOUR® TRANSTAR™ device, shortly named TRANSTAR, at 12 months postoperatively.
From January 2009 to January 2011, consecutive patients who underwent TRANSTAR in 22 European colorectal centers were enrolled in the study. Functional outcomes and quality of life were assessed by the changes in a number of scoring systems (Knowles-Eccersley-Scott-Symptom (KESS) score, ODS score, St. Mark's score, Euro Quality of Life-5 Dimension (EQ-5D) score, and Patient Assessment of Constipation-Quality of Life (PAC-QoL) score), at 12 months as compared to baseline. All complications were recorded and analyzed.
A total of 100 patients (98% female), mean age 60 years, were entered in the study. Statistically significant improvements were seen in the KESS (median 18 vs. 6; p < 0.01), ODS (median 15 vs. 4; p < 0.01), and PAC-Qol scores (median 2.10 vs. 0.86; p < 0.01). St. Mark's and EQ-5D scores improved nonsignificantly. Complications were reported in 11 % of patients, including bleeding (5%), staple line complications (3%), urinary retention (2%), and persistent pain (1%). No major complications or mortality occurred.
TRANSTAR facilitated a tailored, real circumferential full-thickness rectal resection, leading to improved patient functional and quality of life outcomes at 12 months postoperatively. It represents a safe and effective treatment for ODS in local clinical practice, although the sustainability of real-world results needs to be proven in the long-term follow-up.
在患有排便梗阻综合征(ODS)的患者中,吻合器经肛门直肠切除术(STARR)受所用圆形吻合器容量的限制。本前瞻性队列研究旨在评估使用新型CONTOUR® TRANSTAR™装置(简称为TRANSTAR)进行STARR术后12个月的实际临床疗效。
2009年1月至2011年1月,在22个欧洲结直肠中心接受TRANSTAR手术的连续患者被纳入本研究。通过一些评分系统(诺尔斯 - 埃克斯利 - 斯科特症状(KESS)评分、ODS评分、圣马克评分、欧洲五维健康量表(EQ - 5D)评分和便秘患者生活质量评估(PAC - QoL)评分)在术后12个月与基线相比的变化,来评估功能结局和生活质量。记录并分析所有并发症。
共有100例患者(98%为女性),平均年龄60岁,进入本研究。KESS评分(中位数从18降至6;p < 0.01)、ODS评分(中位数从15降至4;p < 0.01)和PAC - Qol评分(中位数从2.10降至0.86;p < 0.01)有统计学意义的改善。圣马克评分和EQ - 5D评分有非显著性改善。11%的患者报告有并发症,包括出血(5%)、吻合口并发症(3%)、尿潴留(2%)和持续性疼痛(1%)。未发生重大并发症或死亡。
TRANSTAR有助于进行量身定制的、真正的全周直肠全层切除术,术后12个月患者的功能和生活质量得到改善。在当地临床实践中,它是一种安全有效的ODS治疗方法,尽管实际结果的可持续性需要长期随访来证实。