Effects of Complete Preservation Versus Partial Preservation of Denonvilliers' Fascia on Postoperative Urogenital Function in Locally Advanced Non-anterior Mid-low Rectal Cancer Patients：A Multicenter，Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Incidence of urinary dysfunction
研究概览
简要总结
Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of rectal adenocarcinoma;
- •Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);
- •Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
- •R0 surgical results is expected by transabdominal or transanal TME/TSME;
- •18 < age (years) < 71, informed consent;
- •Normal erection function (IIEF-5>21), ejaculation function grading as I level, FSFI > 26, normal urinary function (Bladder residual urine<100ml);
- •Preoperative ASA grade I ~ III, no serious systemic disease;
排除标准
- •Preoperatively confirmed peritoneum or distant metastasis;
- •Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;
- •With other malignant diseases;
- •With acute ileus, perforation or hemorrhage,need emergency surgery;
- •Critical organs dysfunction, unable to tolerate laparoscopic surgery;
- •With severe mental illness, cannot be evaluated;
结局指标
主要结局
Incidence of urinary dysfunction
时间窗: 1 month
IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function
Incidence of sexual dysfunction
时间窗: 1 month
IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function
次要结局
- Quality of life assessed with GIQLI questionnaires(9 months)
- 1-year local recurrence(1 year)
- Incidence of sexual dysfunction(9 months)
- 1-year overall survival rate(1 year)
- Positive Circumferential Resection Margin Rate(1 week)
- Incidence of urinary dysfunction(9 months)