[评论]直肠癌术后行盆底康复的治疗效果:多中心FORCE研究的1年随访结果分析

[Comment]Pelvic floor rehabilitation after rectal cancer surgery one-year follow-up of a multicenter randomized clinical trial(FORCE trial)

目的评估在1年随访时间内于直肠低位前切除术后行盆底康复的治疗效果。背景数据直肠低位前切除术后,随着肠道通畅性的恢复,90%的患者会出现肛门直肠功能障碍,严重影响生活质量。然而,目前尚无标准化治疗。FORCE试验表明,与常规治疗相比,患者在采用盆底康复3个月治疗后,可以在大便失禁生活质量量表的部分条目得分和急便感改善方面获益。方法FORCE试验是一项多中心、双臂、随机临床试验。所有接受直肠低位前切除术治疗的患者均被随机分配接受常规治疗或标准化盆底康复计划。主要研究指标是Wexner大便失禁评分,次要研究指标包括低位前切除综合征评分、欧洲癌症研究和治疗组织生活质量量表评分以及健康和大便失禁相关生活质量。评估在随机分组前的基线期、术后3个月和1年的随访期间进行。结果共纳入86例患者,其中盆底康复组40例、对照组46例。与基线期相比,1年后盆底康复组和对照组的Wexner大便失禁评分比较差异无统计学意义(盆底康复组:-3.33,95%CI为-4.41~-2.26;对照组:-2.54,95%CI为-3.54~-1.54,P=0.30)。与3个月后随访结果相似,在基线期没有完全发生大便失禁的患者症状得到改善(盆底康复组:-2.82,95%CI为-3.86~-1.76;对照组:-1.43,95%CI为-2.36~-0.50,P=0.06)。与对照组相比,盆底康复组大便失禁生活质量量表的生活方式条目评分(0.51 vs.-0.13,P=0.03)和应对与行为条目评分增加(0.40 vs.-0.24,P=0.01)。结论在1年的随访时间内,大便失禁评分改善但没有统计学意义,与常规治疗相比,与大便失禁相关的生活质量改善与盆底康复相关。

Objective This study aims to evaluate the effects of pelvic floor rehabilitation(PFR)after low anterior resection(LAR)at one-year follow-up.Summary background data After LAR,with restoration of bowel continuity,up to 90%of patients develop anorectal dysfunction,significantly impacting their quality of life.However,standardized treatment is currently unavailable.The FORCE trial demonstrated the beneficial effects of PFR after three months regarding specific domains of the Fecal Incontinence QoL(FIQL)questionnaire and urgency compared to usual care.Methods The FORCE trial is a multicenter,two-arm,randomized clinical trial.All patients undergoing LAR were randomly assigned to receive either usual care or a standardized PFR program.The primary outcome measure is the Wexner incontinence score,and the secondary endpoints included the LARS score,the EORTC colorectal-specific QoL questionnaire,and health-and fecal incontinence-related QoL.Assessments were conducted at baseline before randomization,at three months and one-year follow-ups.Results A total of 86 patients were included(PFR:n=40,control:n=46).After one year,PFR did not significantly improve Wexner incontinence scores(PFR:-3.33;95%CI,-4.41 to-2.26;control:-2.54,95%CI,-3.54 to-1.54;P=0.30).Similar to the three-month follow-up,patients without near-complete incontinence at baseline showed sustained improvement in fecal incontinence(PFR:-2.82,95%CI,-3.86 to-1.76;control:-1.43,95%CI,-2.36 to-0.50;P=0.06).Significant improvement was reported in the FIQL domains Lifestyle(PFR:0.51,control:-0.13,P=0.03)and Coping and Behavior(PFR:0.40,control:-0.24,P=0.01).Conclusion At one-year follow-up,no significant differences were found in fecal incontinence scores;however,PFR was associated with improved fecal incontinence related QoL compared to usual care.