Preservation Versus Excision of Denonvilliers Fascia in Laparoscopic Pelvic Autonomic Nerve Preserving Surgery 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
- Sexual function
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. PANP (pelvic autonomic nerve preservation) 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 (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).
In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-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 L-PANP;
- •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
- •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
研究组 & 干预措施
Preservation of Denonvilliers Fascia
Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
干预措施: Preservation of Denonvilliers Fascia (Procedure)
Excision of Denonvilliers Fascia
Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
干预措施: Excision of Denonvilliers Fascia (Procedure)
结局指标
主要结局
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
5-year disease free survival rate
时间窗: 60 months
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
次要结局
- 3-year recurrence pattern(36 months)
- Morbidity(36 months)
- 3-year overall survival rate(36 months)
- 5-year overall survival rate(60 months)
- Mortality(36 months)
- 5-year recurrence pattern(60 months)
研究者
Hongbo Wei
Assistant to the Dean
Third Affiliated Hospital, Sun Yat-Sen University