对于接受新辅助化疗、放疗或放疗后临床完全缓解的直肠癌患者，观察等待治疗方法与更好的生活质量和功能结果有关。然而，有关这两个参数的前瞻性数据很少。为了前瞻性地评估随后进行观察等待治疗的患者的生活质量、功能结果，包括肠道、泌尿和性功能。共纳入278名接受新辅助化疗、放疗或放疗后临床完全或近完全缓解的直肠癌患者，其中包括单中心研究(2014年3月至2017年10月)和持续进行的多中心研究(自2017年9月起)。患者通过观察等待方法进行观察。残留病变或复发的情况下，可以进行额外的局部切除或全周围切除。对于至少有24个月随访的患者，数据的分析时间为2021年4月1日至2021年8月27日。使用European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30(EORTC-QLQ-C30)、EORTC-QLQ-CR38或EORTC-QLQ-CR29及36-Item Short-Form Health Survey评估生活质量。问卷和36-Item Short-Form Health Survey的得分范围为0-100分。对于一些量表，高分表示较高的功能水平，而对于其他量表，则表示较高的投诉和症状。使用低前切除综合征评分、Vaizey大小便失禁评分、国际前列腺症状评分、国际勃起功能指数和女性性功能指数评估功能结果。在纳入的278名患者中，187名患者为男性(67%),中位年龄为66岁(34-85岁)。在前24个月中，221名患者(80%)通过观察等待方法进行观察，无需手术，18名患者(6%)接受额外的局部切除，39名患者(14%)接受全周围切除。总体而言，通过观察等待方法进行观察的患者报告了良好的生活质量，随时间的变化有限。在3个月时，221名患者中有56名(25.3%)报告存在严重的肠道功能障碍，在12个月时，53名患者(24.0%)报告存在此问题，在24个月时，55名患者(24.9%)报告存在此问题。在24个月时，151名男性患者中有48名(31.8%)报告存在严重的勃起功能障碍。对于女性患者，性满意度和总的性功能在随访期间下降。接受局部切除的患者报告有更多的肠道功能障碍(18名患者中有10名[55.6%])，而没有接受手术的患者则相对较少。然而，生活质量得分是可比较的。全周围切除后，患者在几个生活质量分项得分方面表现更差。本研究结果表明，接受观察等待方法的直肠癌患者具有良好的生活质量，但一些患者报告存在肠道和性功能障碍。当患者需要手术时，生活质量和功能结果会恶化。这些数据将有助于日常护理中向患者说明接受观察等待方法应该期望的情况。

A watch-and-wait approach for patients with rectal cancer and a clinical complete response after neoadjuvant chemoradiotherapy or radiotherapy is associated with better quality of life and functional outcome. Nevertheless, prospective data on both parameters are scarce.To prospectively evaluate quality of life and functional outcome, including bowel, urinary, and sexual function, of patients following a watch-and-wait approach.A total of 278 patients with rectal cancer and a clinical complete response or near-complete response after neoadjuvant chemoradiotherapy or radiotherapy were included in 2 prospective cohort studies: a single-center study (March 2014 to October 2017) and an ongoing multicenter study (from September 2017). Patients were observed by a watch-and-wait approach. Additional local excision or total mesorectal excision was performed for residual disease or regrowth. Data were analyzed between April 1, 2021, and August 27, 2021, for patients with a minimum follow-up of 24 months.Quality of life was evaluated with the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), EORTC-QLQ-CR38, or EORTC-QLQ-CR29 and 36-Item Short-Form Health Survey. The score for the questionnaires and 36-Item Short-Form Health Survey ranges from 0 to 100. For some scales, a high score indicates a high level of functioning, and for others it indicates a high level of complaints and symptomatology. Functional outcome was assessed by the Low Anterior Resection Syndrome score, Vaizey incontinence score, International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index.Of 278 patients included, 187 were male (67%), and the median age was 66 years (range, 34-85 years). In the first 24 months, 221 patients (80%) were observed by a watch-and-wait approach without requiring surgery, 18 patients (6%) underwent additional local excision, and 39 patients (14%) underwent total mesorectal excision. In general, patients observed by a watch-and-wait approach reported good quality of life, with limited variation over time. At 3 months, 56 of 221 patients (25.3%) reported major bowel dysfunction; at 12 months, 53 patients (24.0%) reported it; and at 24 months, 55 patients (24.9%) reported it. At 24 months, 48 of 151 male patients (31.8%) reported severe erectile dysfunction. For female patients, sexual satisfaction and overall sexual function decreased during follow-up. Patients who underwent local excision reported more major bowel dysfunction (10 of 18 patients [55.6%]) compared with those without additional surgery. Quality-of-life scores, however, were comparable. After total mesorectal excision, patients scored significantly worse on several quality-of-life subscales.Results of this study suggest that patients with rectal cancer who were observed by a watch-and-wait approach had good quality of life, with some patients reporting bowel and sexual dysfunction. Quality of life and functional outcome deteriorated when patients required surgery. These data will be useful in daily care to counsel patients on what to expect from a watch-and-wait approach.