Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 18
- 主要终点
- Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA
研究概览
简要总结
Hypothesis:
In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65. Unlike colon cancer, technical management remains challenging with unresolved operating difficulties. Morbidity of surgical procedures remains high with a very large number of preventive or curative stoma derivations.
Reference in surgical treatment is total excision of the rectum and its mesentery, followed by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate of fistula that results is reported in the literature between 15 and 25%.
An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and mortality are reduced, and patient's quality of life greatly improved. Direct costs (consumables intraoperative, hospitalization, stoma complications) and indirect (pocket-fitting stoma) are greatly reduced.
This study is a multicentre, two arms, phase 2 clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven rectal adenocarcinoma.
- •Medium or lower rectum tumour requiring removal of the entire rectum and its mesorectum.
- •T1 N+ or T2 N+ or T3 N+ or T3 N0 and M0 tumour.
- •Age between 18 and 75 years .
- •Sphincter continence compatible with coloanal anastomosis.
- •Patients who received preoperative radiotherapy alone or chemotherapy and radiotherapy.
- •Patient affiliated to social security.
- •For patients of childbearing age, use of contraception.
- •Patient information and consent for study participation
排除标准
- •Other histology of rectal cancer.
- •T1 N0 or T2 N0 or T4 tumour.
- •Metastatic disease M
- •History of cancer except cervix in situ carcinoma or skin basal cell carcinoma.
- •Patient with psychological, social, family or geographical reasons who couldn't be treated or monitored regularly by the criteria of the study
- •Patients deprived of liberty or under guardianship.
- •Pregnant or nursing women.
结局指标
主要结局
Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA
时间窗: Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.
Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma (curatively for 2-stage CA or prophylactic-based for CA). AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. Assuming an efficacy rates of 85% (null hypothesis) and 95% (alternative hypothesis), and relied on a superiority test at the 5% significance level (one-sided) with 80% power, 53 eligible and assessable patients were required. Efficacy of the intervention was concluded if at least 49 patients had no symptomatic AL at day 30.
次要结局
- Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA(Colo-anal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.)
- Postoperative Mortality(From the date of surgery to 30 days after surgery (2SCA or CAA))
- Number of Participants With Anal Incontinence at 12 Months(At 12 months after surgery (2SCA or CAA))
- Stomata Bypass (Preventive or Therapeutic)(Presence of stomata bypass was evaluated at 30 days, 1 year and 2 years after surgery (2SCA or CAA))
- Post-operative Morbidity(During the 30 first days after surgery (2SCA or CAA))
- Number of Participants With Anal Incontinence at 6 Months(At 6 months after surgery (2SCA or CAA))
- Progression-free Survival(1 and 2 years after surgery (2SCA or CAA))
- Number of Participants With Anal Incontinence at 24 Months(At 24 months after surgery (2SCA or CAA))