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患者报告腹腔镜和开放直肠癌手术治疗后的泌尿生殖系统功能障碍的随机试验(COLOR II)。

Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II).

机构信息

Scandinavian Surgical Outcomes Research Group, Department of Surgery, Sahlgrenska University Hospital/Östra, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden; Department of Surgery, Alingsås Hospital, Alingsås, Sweden.

出版信息

Br J Surg. 2014 Sep;101(10):1272-9. doi: 10.1002/bjs.9550. Epub 2014 Jun 12.

Abstract

BACKGROUND

This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer.

METHODS

Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaire before surgery, and after 4 weeks, 6, 12 and 24 months. Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning, sexual enjoyment, male and female sexual problems, and micturition symptoms.

RESULTS

Of 617 randomized patients, 385 completed this phase of the trial. Their mean age was 67·1 years. Surgery caused an anticipated reduction in genitourinary function after 4 weeks, with no significant differences between laparoscopic and open approaches. An improvement in sexual dysfunction was seen in the first year, but some male sexual problems persisted. Before operation 64·5 per cent of men in the laparoscopic group and 55·6 per cent in the open group reported some degree of erectile dysfunction. This increased to 81·1 and 80·5 per cent respectively 4 weeks after surgery, and 76·3 versus 75·5 per cent at 12 months, with no significant differences between groups. Micturition symptoms were less affected than sexual function and gradually improved to preoperative levels by 6 months. Adjusting for confounders, including radiotherapy, did not change these results.

CONCLUSION

Sexual dysfunction is common in patients with rectal cancer, and treatment (including surgery) increases the proportion of patients affected. A laparoscopic approach does not change this.

REGISTRATION NUMBER

NCT00297791 (http://www.clinicaltrials.gov).

摘要

背景

本文报道了腹腔镜与开腹直肠癌根治术随机对照试验后患者报告的性功能障碍和排尿症状。

方法

COLOR II 随机试验患者在术前和术后 4 周、6 个月、12 个月和 24 个月时完成欧洲癌症研究与治疗组织(EORTC)QLQ-CR38 问卷。使用各时间点从基线值变化的 100 分制调整均数差值,评估性功能、性享受、男性和女性性问题以及排尿症状领域的变化。

结果

617 例随机患者中,385 例完成了这一阶段的试验。他们的平均年龄为 67.1 岁。术后 4 周生殖泌尿系统功能出现预期下降,腹腔镜与开腹手术之间无显著差异。性功能障碍在第一年有所改善,但一些男性性问题仍持续存在。术前,腹腔镜组 64.5%的男性和开腹组 55.6%的男性报告有不同程度的勃起功能障碍。术后 4 周分别增加至 81.1%和 80.5%,12 个月时分别为 76.3%和 75.5%,两组间无显著差异。与性功能障碍相比,排尿症状受影响较小,且在 6 个月时逐渐恢复到术前水平。调整包括放疗在内的混杂因素后,这些结果并未改变。

结论

直肠癌患者性功能障碍常见,治疗(包括手术)会增加受影响的患者比例,腹腔镜手术并不能改变这一情况。

登记号

NCT00297791(http://www.clinicaltrials.gov)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7b9/4282093/29c9864cec9d/bjs0101-1272-f1.jpg

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