Donovan Katherine F, Tomada Elisa Paoluzzi, Carmichael Heather, Ricardo Alison, Berger Natalie, Bonaccorso Antoinette, Alavi Karim, Zaghiyan Karen, Pigazzi Alessio, Sands Dana, DeBeche-Adams Theresa, Chadi Sami A, McLemore Elisabeth C, Marks John H, Maykel Justin A, Shawki Sherief F, Steele Scott R, Albert Matthew, Whiteford Mark H, Wexner Steven D, Sylla Patricia
Division of Colon and Rectal Surgery, Mount Sinai Hospital, 5 East 98th Street, Box 1259, New York, NY, 10029, USA.
Department of Biomedical Sciences, Humanitas University - Humanitas Research Hospital, Milan, Italy.
Surg Endosc. 2025 Aug 11. doi: 10.1007/s00464-025-11959-z.
BACKGROUND: Total mesorectal excision (TME) is known to adversely impact functional outcomes. In a recent Phase II multicenter prospective trial, significant decline in defecatory and sexual function and fecal incontinence-related quality of life (FIQL) was documented following transanal TME (taTME) for rectal cancer, with neoadjuvant treatment (NAT) identified as a predictor of worse function. However, the impact of NAT on baseline function is poorly understood. METHODS: Patients in a Phase II multicenter trial (NCT03144765) who underwent taTME with or without NAT completed validated functional questionnaires assessing fecal incontinence (FIQL, Wexner), defecatory function (COREFO), urinary function (IPSS), and sexual function (male: IIEF, female: FSFI). Data were collected pre-NAT, post-NAT, 3-4 months after ileostomy closure (FQ1), and 12-18 months post-taTME (FQ2). Paired t-tests or Wilcoxon tests compared scores between timepoints. RESULTS: Of 71 patients who received NAT, 10 completed both pre- and post-NAT surveys. Median age was 58 years [IQR 48-61], and 7 patients were male. Tumors were located a median 4.75 cm [IQR 4.0-6.0 cm] from the anal verge. Median baseline COREFO score was 38.1 [29.2-49.8], indicating baseline defecatory dysfunction. No significant differences were observed between pre- and post-NAT scores, though FIQL scores demonstrated a trend toward worse incontinence-related quality of life post-NAT (p = 0.06). Postoperatively, Wexner, FIQL, and COREFO worsened from baseline and post-NAT levels, with partial improvement at 18 months post-op, without returning to baseline. No differences were observed in IPSS scores. IIEF scores showed no new erectile dysfunction post-NAT, but low sample size precluded FSFI analysis. CONCLUSION: Defecatory, urinary, and sexual function were not significantly altered by NAT, though FIQL trends suggest worsening incontinence-related quality of life. Assessment of function and health-related quality of life at baseline and after each phase of therapy may help better inform patients about the impact of multimodal rectal cancer treatment.
背景：全直肠系膜切除术（TME）已知会对功能结局产生不利影响。在最近一项II期多中心前瞻性试验中，记录了直肠癌经肛门全直肠系膜切除术（taTME）后排便和性功能以及粪便失禁相关生活质量（FIQL）显著下降，新辅助治疗（NAT）被确定为功能较差的预测因素。然而，NAT对基线功能的影响了解甚少。 方法：一项II期多中心试验（NCT03144765）中接受或未接受NAT的taTME患者完成了经过验证的功能问卷，评估粪便失禁（FIQL、韦克斯纳）、排便功能（COREFO）、泌尿功能（IPSS）和性功能（男性：IIEF，女性：FSFI）。在新辅助治疗前、新辅助治疗后、回肠造口关闭后3 - 4个月（FQ1）以及taTME后12 - 18个月（FQ2）收集数据。采用配对t检验或威尔科克森检验比较各时间点的得分。 结果：在71例接受NAT的患者中，10例完成了新辅助治疗前和后的调查。中位年龄为58岁[四分位间距48 - 61岁]，7例为男性。肿瘤距肛缘的中位距离为4.75 cm[四分位间距4.0 - 6.0 cm]。COREFO基线中位得分为38.1[29.2 - 49.8]，表明存在基线排便功能障碍。新辅助治疗前和后的得分之间未观察到显著差异，尽管FIQL得分显示新辅助治疗后失禁相关生活质量有变差的趋势（p = 0.06）。术后，韦克斯纳、FIQL和COREFO得分较基线和新辅助治疗后水平恶化，术后18个月部分改善，但未恢复到基线水平。IPSS得分未观察到差异。IIEF得分显示新辅助治疗后无新的勃起功能障碍，但样本量小无法进行FSFI分析。 结论：新辅助治疗未显著改变排便、泌尿和性功能，尽管FIQL趋势表明失禁相关生活质量变差。在基线和每个治疗阶段后评估功能和健康相关生活质量可能有助于更好地告知患者多模式直肠癌治疗的影响。
Cochrane Database Syst Rev. 2021-2-3
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