Shi W K, Li Y H, Qiu X Y, Xiao Y, Zhou J L, Wu B, Lin G L
Department of General Surgery, Peking Union Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Department of Surgery, Peking Union Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2022 Apr 25;25(4):348-356. doi: 10.3760/cma.j.cn441530-20210808-00315.
To investigate quality of life (QoL) of patients with locally advanced rectal cancer (LARC) who underwent low anterior resection with protective stoma under neoadjuvant therapy mode, and to explore the changes of QoL of patients from before neoadjuvant therapy to 12 months after stoma reversal. A descriptive case series study was carried out. A retrospective study was performed on patients with mid and low LARC who received complete neoadjuvant long course radiotherapy and chemotherapy, followed by radical low anterior resection (LAR) combined with protective stoma at Peking Union Medical College Hospital from December 2017 to January 2020. Inclusion criteria: (1) patients with rectal MRI assessment of mT3-4b or mN1-2 without distant metastasis (M0) before neoadjuvant therapy; (2) distance from tumor lower margin to the anal verge <12 cm; (3) rectal adenocarcinoma confirmed by biopsy before neoadjuvant therapy; (4) complete cycle of neoadjuvant therapy; (5) patients undergoing radical LAR with sphincter preservation and protective ostomy; (6) patients receiving follow-up for more than 12 months after stoma reversal. Exclusion criteria: (1) patients as grade Ⅳ to Ⅴclassified by the American Society of Anesthesiologists (ASA); (2) patients with multiple primary colorectal cancer; (3) patients with history of other malignant tumors in the past 5 years; (4) patients of emergency surgery; (5) pregnant or lactating women; (6) patients with history of severe mental illness; (7) patients with contraindication of MRI, radiotherapy, chemotherapy, or surgical treatment. A total of 83 patients were enrolled, including 51 males and 28 females with median age of 59 years and mean BMI of (24.4±3.1) kg/m(2). EORTC QLQ-CR29, international erectile function index (IIEF), Wexner constipation score and low anterior resection syndrome (LARS) score were applied to investigate the QoL of the patients before neoadjuvant therapy, 3 and 12 months after ostomy reversal, including rectal anal function and sexual function. M (P25, P75) was used for the scores of the scale. (1) EORTC QLQ-CR29 score showed that before neoadjuvant therapy, before surgery, 3 months and 12 months after ostomy reversal, anxiety [64.4 (52, 0, 82.5), 75.3 (66.0, 89.5), 82.6 (78.5, 90.0), 83.6 (78.0, 91.0)] and concern about body image [76.8 (66.0, 92.0), 81.1 (76.5, 91.5), 85.5 (82.5, 94.0), 86.1 (82.0, 92.0)] were improved (all <0.01); pelvic pain [5.4 (2.0, 8.0), 5, 0 (2.0, 7.8), 3.9 (1.0, 5.0), 3.0 (1.0, 5.0)], urinary incontinence [15.7 (7.0, 22.0), 11.1 (0, 17.5), 10.0 (0, 17.0), 9.9 (0, 16.0)], impotence [14.3 (4.2, 19.0), 12.2 (0, 16.8), 5.6 (0, 10.0), 5.2 (0.2, 8.0)], urinate [26.4 (13.0, 38.5), 13.9 (0, 20.0), 13.4 (2.5, 21.5), 13.2 (2.0, 20.0)] and mucous bloody stool [4.7 (3.0, 6.0), 2.6 (0, 5.0), 2.2 (0, 5.0), 1.9 (0, 4.0)] were improved as well (all <0.01). The scores fluctuated in the improvement of male sexual function, abdominal pain, dry mouth, worry about body mass change, skin pain and dyspareunia, but the symptoms were significantly improved after ostomy reversal compared with before neoadjuvant therapy (all <0.05). There were no significant changes in female sexual function, dysuria, dysgeusia and fecal incontinence after ostomy reversal compared with before neoadjuvant therapy (all >0.05). (2) IIEF scale showed that all scores were similar before and after neoadjuvant therapy (all >0.05). (3) Rectal and anal function scale revealed that before neoadjuvant therapy, before operation, 3 months and 12 months after stoma reversal, gas incontinence [3.1 (0, 4.0), 2.3 (0, 4.0), 1.8 (0, 4.0), 1.2 (0, 3.0)] and urgent defecation [7.2 (0, 11.0), 5.2 (0, 11.0), 2.9 (0, 9.0), 1.7 (0, 0)] were improved (all <0.001). In terms of improving incomplete emptying sensation, the symptoms fluctuated, but the symptoms improved significantly after ostomy reversal compared with before neoadjuvant therapy (all <0.05). While the symptoms of assistance with defecation [0 (0, 0), 0.7 (0, 1.0), 0.6 (0, 1.0), 0.7 (0, 1.0)] and defecation failure [0.2 (0, 0), 1.0 (0, 2.0), 0.8 (0, 1.5), 0.8 (0, 1.0)] showed a worsening trend (all <0.001). Stratified analysis was performed on patients with different efficacy of neoadjuvant therapy to compare the changes in QoL before and after neoadjuvant therapy. Patients with less sensitive and more sensitive neoadjuvant therapy showed similar changes in function and symptoms. Patients with less sensitive therapy showed significant improvement in dysuria, urinary incontinence, skin pain and dyspareunia (all <0.05), and the symptom of defecation frequency in more sensitive patients was significantly improved (<0.05). For patients with LARC, neoadjuvant radiochemotherapy combined with radical LAR and protective stoma can improve QoL in many aspects. It is noted that patients show a worsening trend in the need for assistance with defecation and in defecation failure.
探讨新辅助治疗模式下接受低位前切除术并带有保护性造口的局部晚期直肠癌（LARC）患者的生活质量（QoL），并探究患者从新辅助治疗前到造口还纳术后12个月生活质量的变化。开展了一项描述性病例系列研究。对2017年12月至2020年1月在北京协和医院接受完整新辅助长程放化疗，随后行根治性低位前切除术（LAR）并带有保护性造口的中低位LARC患者进行回顾性研究。纳入标准：（1）新辅助治疗前经直肠MRI评估为mT3-4b或mN1-2且无远处转移（M0）的患者；（2）肿瘤下缘距肛缘<12 cm；（3）新辅助治疗前行活检确诊为直肠腺癌；（4）完成新辅助治疗周期；（5）接受保留括约肌的根治性LAR及保护性造口术的患者；（6）造口还纳术后接受随访超过12个月的患者。排除标准：（1）美国麻醉医师协会（ASA）分级为Ⅳ至Ⅴ级的患者；（2）患有多发性原发性结直肠癌的患者；（3）过去5年内有其他恶性肿瘤病史的患者；（4）急诊手术患者；（5）孕妇或哺乳期妇女；（6）有严重精神疾病史的患者；（7）有MRI、放疗、化疗或手术治疗禁忌证的患者。共纳入83例患者，其中男性51例，女性28例，中位年龄59岁，平均BMI为（24.4±3.1）kg/m²。应用欧洲癌症研究与治疗组织生活质量问卷结直肠癌模块（EORTC QLQ-CR29）、国际勃起功能指数（IIEF）、韦克斯纳便秘评分和低位前切除综合征（LARS）评分来调查患者在新辅助治疗前、造口还纳术后3个月和12个月的生活质量，包括直肠肛门功能和性功能。量表评分采用M（P25，P75）表示。（1）EORTC QLQ-CR29评分显示，新辅助治疗前、手术前、造口还纳术后3个月和12个月，焦虑[64.4（52.0，82.5）、75.3（66.0，89.5）、82.6（78.5，90.0）、83.6（78.0，91.0）]和对身体形象的关注[76.8（66.0，92.0）、81.1（76.5，91.5）、85.5（82.5，94.0）、86.1（82.0，92.0）]均有所改善（均P<0.01）；盆腔疼痛[5.4（2.0，8.0）、5.0（2.0，7.8）、3.9（1.0，5.0）、3.0（1.0，5.0）]、尿失禁[15.7（7.0，22.0）、11.1（0，17.5）、10.0（0，17.0）、9.9（0，16.0）]、阳痿[14.3（4.2，19.0）、12.2（0，16.8）、5.6（0，10.0）、5.2（0.2，8.0）]、排尿[26.4（13.0，38.5）、13.9（0，20.0）、13.4（2.5，21.5）、13.2（2.0，20.0）]和黏液血便[4.7（3.0，6.0）、2.6（0，5.0）、2.2（0，5.0）、1.9（0，4.0）]也均有所改善（均P<0.01）。男性性功能、腹痛、口干、对体重变化的担忧、皮肤疼痛和性交困难在改善过程中评分有波动，但造口还纳术后与新辅助治疗前相比症状明显改善（均P<0.05）。造口还纳术后与新辅助治疗前相比，女性性功能、排尿困难、味觉障碍和大便失禁无明显变化（均P>0.05）。（2）IIEF量表显示，新辅助治疗前后所有评分均相似（均P>0.05）。（3）直肠肛门功能量表显示，新辅助治疗前、手术前、造口还纳术后3个月和12个月，气体失禁[3.1（0，4.0）、2.3（0，4.0）、1.8（0，4.0）、1.2（0，3.0）]和紧急排便[7.2（0，11.0）、5.2（0，11.0）、2.9（0，9.0）、1.7（0，0）]均有所改善（均P<0.001）。在改善排便不尽感方面，症状有波动，但造口还纳术后与新辅助治疗前相比症状明显改善（均P<0.05）。而辅助排便[0（0，0）、0.7（0，1.0）、0.6（0，1.0）、0.7（0，1.0）]和排便失败[0.2（0，0）、1.0（0，2.0）、0.8（0，1.5）、0.8（0，1.0）]的症状呈恶化趋势（均P<0.001）。对新辅助治疗疗效不同的患者进行分层分析，比较新辅助治疗前后生活质量的变化。新辅助治疗敏感性较低和较高的患者在功能和症状方面的变化相似。敏感性较低的患者排尿困难、尿失禁、皮肤疼痛和性交困难有显著改善（均P<0.05），敏感性较高的患者排便频率症状有显著改善（P<0.05）。对于LARC患者，新辅助放化疗联合根治性LAR和保护性造口可在多个方面改善生活质量。需要注意的是，患者在辅助排便需求和排便失败方面呈恶化趋势。
