Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands.
Ann Surg. 2022 Jul 1;276(1):38-45. doi: 10.1097/SLA.0000000000005353. Epub 2021 Dec 28.
To investigate the effects of PFR after LAR compared to usual care without PFR.
Functional complaints, including fecal incontinence, often occur after LAR for rectal cancer. Controversy exists about the effectiveness of PFR in improving such postoperative functional outcomes.
This was a multicenter, randomized controlled trial involving 17 Dutch centers. Patients after LAR for rectal cancer were randomly assigned (1:1) to usual care or PFR and stratified by sex and administration of neoadjuvant therapy. Selection was not based on severity of complaints at baseline. Baseline measurements were taken 3 months after surgery without temporary stoma construction or 6 weeks after stoma closure. The primary outcome measure was the change in Wexner incontinence scores 3 months after randomization. Secondary outcomes were fecal incontinence-related quality of life, colorectal-specific quality of life, and the LARS scores.
Between October 2017 and March 2020, 128 patients were enrolled and 106 randomly assigned (PFR n = 51, control n = 55); 95 patients (PFR n = 44, control n = 51) were assessable for final analysis. PFR did not lead to larger changes in Wexner incontinence scores in nonselected patients after LAR compared to usual care [PFR: -2.3, 95% confidence interval (CI) -3.3 to -1.4, control: -1.3, 95% CI -2.2 to -0.4, P = 0.13]. However, PFR was associated with less urgency at follow-up (odds ratio 0.22, 95% CI 0.06-0.86). Patients without near-complete incontinence reported larger Wexner score improvements after PFR (PFR: -2.1, 95% CI -3.1 to -1.1, control: -0.7, 95% CI -1.6 to 0.2, P = 0.045). For patients with at least moderate incontinence PFR resulted in relevant improvements in all fecal incontinence-related quality of life domains, while the control group deteriorated. These improvements were even larger when patients with near-complete incontinence were excluded. No serious adverse PFR-related events occurred.
No benefit was found of PFR in all patients but several subgroups were identified that did benefit from PFR, such as patients with urgency or with at least moderate incontinence and no near-complete incontinence. A selective referral policy (65%-85% of all patients) is suggested to improve postoperative functional outcomes for patients after LAR for rectal cancer.
Netherlands Trial Registration, NTR5469, registered on 3 September 2015.
研究 LAR 后与常规护理相比，行预防性肛门直肠指检（PFR）对患者的影响。
直肠癌患者行 LAR 后常出现功能障碍，包括粪便失禁。目前，对于 PFR 改善术后功能结局的效果仍存在争议。
这是一项多中心、随机对照试验，共纳入 17 个荷兰中心。LAR 术后直肠癌患者按 1:1 随机分为常规护理组或 PFR 组，并根据性别和新辅助治疗进行分层。入选时未基于基线时的严重程度进行选择。基线测量在无临时造口或造口关闭后 6 周进行。主要结局测量指标为随机分组后 3 个月时 Wexner 失禁评分的变化。次要结局指标包括粪便失禁相关生活质量、结直肠特异性生活质量和 LARS 评分。
2017 年 10 月至 2020 年 3 月期间，共纳入 128 例患者，其中 106 例患者被随机分配（PFR 组 51 例，对照组 55 例）；95 例患者（PFR 组 44 例，对照组 51 例）可进行最终分析。与常规护理相比，非选择性患者在 LAR 后行 PFR 并未导致 Wexner 失禁评分的更大变化[PFR：-2.3，95%置信区间（CI）-3.3 至-1.4，对照组：-1.3，95%CI-2.2 至-0.4，P=0.13]。然而，PFR 与随访时的紧迫性降低有关（比值比 0.22，95%CI 0.06-0.86）。无接近完全失禁的患者报告 PFR 后 Wexner 评分改善更大（PFR：-2.1，95%CI-3.1 至-1.1，对照组：-0.7，95%CI-1.6 至 0.2，P=0.045）。对于至少存在中度失禁的患者，PFR 导致所有与粪便失禁相关的生活质量领域均有明显改善，而对照组则恶化。当排除接近完全失禁的患者时，这些改善甚至更大。未发生与 PFR 相关的严重不良事件。
并非所有患者均从 PFR 中获益，但可识别出一些获益的亚组，如存在急迫感或至少存在中度失禁且无接近完全失禁的患者。建议采用选择性转诊策略（所有患者的 65%-85%）来改善直肠癌患者 LAR 术后的功能结局。
荷兰试验注册，NTR5469，于 2015 年 9 月 3 日注册。
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