A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Completion of transabdominal ISR
研究概览
简要总结
The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.
详细描述
The intersphincteric resection (ISR) for the treatment of distal rectal cancer has been a complex two-step surgical procedure consisting of transabdominal mobilization of the anorectum and transanal bowel resection with handsewn coloanal anastomosis. The availability of robotic systems may facilitate the transabdominal approach, simplify the surgical procedures, and achieve better anorectal function for patients with distal rectal cancer requiring an ISR. Consecutive 40 patients with distal rectal cancer undergoing the single-step robotic transabdominal ISR with the intent-to-treat principle will be recruited. The risk factors for a failed transabdominal ISR were identified from the prospectively maintained clinicopathologic data using univariate and multivariate analysis. The surgical outcomes, the anorectal function, and the tumor recurrence were compared between patients with a successful or failed robotic transabdominal ISR. The investigators believe that the present project can facilitate the development of the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer in our hospital and even in Taiwan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of ISR;
- •Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma;
- •Curative and elective surgery;
- •American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients;
- •Age between 20 and 75 years.
排除标准
- •cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs;
- •Evidence of distant metastasis;
- •Primary tumor mass≧8 cm in diameter;
- •Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ;
- •Previous major surgery of low upper abdomen;
- •The adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic lymph node dissection. (7) Patients with poor anorectal function (Wexner incontinence Score≧ 10)
结局指标
主要结局
Completion of transabdominal ISR
时间窗: About one week
1. The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis; 2. the proximal and distal stapled tissue doughnuts recovered from EEA device were intact; 3. A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen; 4. To define a successful transabdominal total ISR, besides the above-mentioned three criteria, the anastomotic site should be checked by immediate anoscopy to confirm the stapling line is approximately at the level of anal intersphincteric groove.
次要结局
- Circumferential resection margin (CRM)(About one week)
- Distal and proximal resection margin(About one week)
- Length of postoperative ileus(30 days)
- Degree of postoperative pain(After patients' discharge from hospital, an average of 7 days)
- Length of operation time(Through the completion of surgery, an average of 5 hours)
- Hospitalization(After patients' discharge from hospital, an average of 7 days)
- Intraoperative complications(Within 5 hours)
- The wound infection(30 days)
- Fecal incontinence(6 months)
- Acute anastomotic leakage(30 days)
- Questionnaire to assess disability(6 months)
- Chronic anastomotic leakage(6 months)