Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in International Index of Erectile Function [IIEF] score
研究概览
简要总结
This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years < age < 80 years
- •Matching the diagnostic criteria;
- •tumor located 3 cm from anal verge
- •Clinically diagnosed cT1-3N0-2 M0 lesions
- •Tumor size of 4 cm or less
- •ASA 1-3 scores;
- •ECOG score is 0-1;
- •Adequate preoperative sphincter function
排除标准
- •Requiring a Mile's procedure
- •Fecal incontinence;
- •Previous abdominal surgery
- •Severe mental disease.
- •Intolerance of surgery for severe comorbidities
- •Emergency operation due to complication
- •Pregnant woman or lactating woman
结局指标
主要结局
Change in International Index of Erectile Function [IIEF] score
时间窗: 18 months
Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED)
Change in Female Sexual Function Index [FSFI]
时间窗: 18 months
Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder.
Change in urinary function
时间窗: 6 months
The days of indwelling catheter after operation The overall efficiency of urination function
Change in FIQL scores
时间窗: 18 months
Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered
次要结局
未报告次要终点
研究者
Li Chuan
Principal Investigator
Southwest Hospital, China