Comparisons of Urinary and Sexual Function Protection and Long-term Outcomes Between Laparoscopy-assisted and Open Pelvic Autonomic Nerve Preservation Total Mesorectum Excision for Male Mid-low Rectal Cancer Patients: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).
Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age from over 20 to under 60 years;
- •Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
- •Mid-low rectal cancer (distance from anal edge≤12cm);
- •cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
- •Expected curative resection through both L-PANP-TME and O-PANP-TME;
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- •ASA (American Society of Anesthesiology) score class I, II, or III;
- •Written informed consent;
- •Urinary and sexual function normal preoperatively
排除标准
- •Women during pregnancy or breast-feeding;
- •Severe mental disorder;
- •History of previous pelvic surgery;
- •Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
- •History of other malignant disease within past five years;
- •History of unstable angina or myocardial infarction within past six months;
- •History of cerebrovascular accident within past six months;
- •History of continuous systematic administration of corticosteroids within one month;
- •Contraindication of heart, brain, lung, etc dysfunction;
- •Requirement of simultaneous surgery for other disease;
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
- •Rectal cancer invades surrounding tissues;
- •Existence of genuine incontinence or severe stress incontinence preoperatively
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months
Urinary function
时间窗: 36 months
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
5-year disease free survival rate
时间窗: 60 months
Sexual function
时间窗: 36 months
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
次要结局
- Morbidity(36 months)
- 3-year overall survival rate(36 months)
- 3-year recurrence pattern(36 months)
- Mortality(36 months)
- 5-year overall survival rate(60 months)
- 5-year recurrence pattern(60 months)
研究者
Hongbo Wei
Chief of surgery
Third Affiliated Hospital, Sun Yat-Sen University