低位直肠癌 2 阶段 Turnbull-Cutait 拉通结肠肛门吻合术的长期结果:一项随机临床试验。
Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial.
发表日期:2024 Jul 10
作者:
Sebastiano Biondo, Oriana Barrios, Loris Trenti, Eloy Espin, Francesco Bianco, Armando Falato, Silvia De Franciscis, Alejandro Solis, Esther Kreisler,
来源:
JAMA Surgery
摘要:
在接受低位直肠癌手术的患者中,与与转道回肠造口术和进一步回肠造口术逆转相关的标准手工缝制结肠肛门吻合术相比,2 期 Turnbull-Cutait 拉穿式手工缝制结肠肛门吻合术在术后发病率方面具有优势。 -这两种技术在直肠癌超低位直肠切除术后的长期结果。在这项随机多中心临床试验中,患者和外科医生都没有对技术进行盲法。患者在 3 个中心招募。接受超低位前直肠切除术需要手工缝制结肠肛门吻合术的患者被随机分配至两期Turnbull-Cutait拉通式手工缝制结肠肛门吻合术(n = 46)或标准手工缝制结肠肛门吻合术联合回肠转道造口术(n = 46) ).所有患者均接受超低位前切除术。分配到 2 阶段 Turnbull-Cutait 拉穿组的患者通过肛管接受了一段左结肠的外部取出。 6至10天后,切除外置结肠并进行延迟手工缝制结肠肛门吻合术。对于接受标准结肠肛门吻合术的患者,首次手术时采用转道回肠造口进行手工缝制结肠肛门吻合术。辅助治疗完成后约 6 至 8 个月安排回肠造口闭合。该研究旨在比较两组在术后 3 年的长期手术相关发病率、功能和肿瘤学结果方面的差异。数据分析时间为2018年10月1日至2021年10月31日。第一项研究中随机分配的92名患者被纳入为期3年的随访。两组的总体发病率显示,15名患者(16.3%)出现并发症,差异为6.52(95% CI,-8.93至21.79)。 2期Turnbull-Cutait拉穿组和手缝结肠肛管吻合组分别有9例患者(19.6%)和6例患者(13.0%)出现并发症,但差异无统计学意义(P = .57)。各组之间的肿瘤学结果具有可比性。使用 Wexner 失禁评分评估 CCA 组和 TCA 组的长期大便失禁情况分别为 10.9 (5.50-15.5) vs 13.0 (7.25-16.0; P = .92),低前切除综合征评分为 32.0 (21.0- 37.0) vs 34.0 (23.2-38.5; P = .76),结直肠功能结果评分为 38.5 (23.0-47.1) vs 40.8 (23.3-58.2; P = .30)。 在本研究中,经过 3 年随访在上升期,超低位直肠癌的 2 阶段 Turnbull-Cutait 吻合术可被视为一种手术替代方案,其具有避免临时造口的宝贵益处,在发病率、大便失禁、患者满意度、生活质量、与回肠造口手工缝制结肠肛门吻合术相比的肿瘤学结果。ClinicalTrials.gov 标识符:NCT01766661。
In patients operated on for low rectal cancer, 2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis provides benefits in terms of postoperative morbidity compared with standard hand-sewn coloanal anastomosis associated with diverting ileostomy and further ileostomy reversal.To compare long-term results of these 2 techniques after ultralow rectal resection for rectal cancer.In this randomized multicenter clinical trial, neither patients nor surgeons were blinded for technique. Patients were recruited in 3 centers. Patients undergoing ultralow anterior rectal resection needing hand-sewn coloanal anastomosis were randomly assigned to 2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis (n = 46) or standard hand-sewn coloanal anastomosis associated with diverting ileostomy (n = 46).All patients underwent ultralow anterior resection. Patients assigned to the 2-stage Turnbull-Cutait pull-through group underwent exteriorization of a segment of left colon through the anal canal. After 6 to 10 days, the exteriorized colon was resected and a delayed hand-sewn coloanal anastomosis performed. For patients assigned to standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy during the first operation. Ileostomy closure was scheduled after adjuvant treatment was completed in about 6 to 8 months.The study aimed to compare the differences between the 2 groups in terms of long-term surgery-related morbidity, functional, and oncological outcomes at 3 years postoperatively. Data were analyzed from October 1, 2018, through October 31, 2021.The 92 patients randomized in the first study were included for the 3-year follow-up. The overall morbidity rate in the 2 groups showed that 15 patients (16.3%) had complications with a difference of 6.52 (95% CI, -8.93 to 21.79). Nine patients (19.6%) and 6 patients (13.0%) in the 2-stage Turnbull-Cutait pull-through group and hand-sewn coloanal anastomosis group, respectively, had complications without statistically significant differences (P = .57). Oncological results were comparable between the groups. Long-term fecal continence in the CCA and TCA groups, respectively, assessed using the Wexner Incontinence Score was 10.9 (5.50-15.5) vs 13.0 (7.25-16.0; P = .92), Low Anterior Resection Syndrome score was 32.0 (21.0-37.0) vs 34.0 (23.2-38.5; P = .76), and Colorectal Functional Outcome score was 38.5 (23.0-47.1) vs 40.8 (23.3-58.2; P = .30).In this study, after a 3-year follow-up period, 2-stage Turnbull-Cutait anastomosis for ultralow rectal cancer could be considered as a surgical alternative that has the valuable benefit of avoiding a temporary stoma with similar results in terms of morbidity, fecal continence, patient satisfaction, quality of life, and oncological outcomes when compared with hand-sewn coloanal anastomosis with ileostomy.ClinicalTrials.gov Identifier: NCT01766661.