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Cola

Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.

Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.

After surgical resection, the colon is exteriorized through the anus and attached to the buttock.

By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation

2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)

After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.

In the absence of fistula, the patient will reoperation for stoma closure of its branch

Colo-anal anastomosis (CAA)

EVRARD Serge, PU-PH

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.

Two multicenter parallel single-arm phase II trials.

One trial assessing 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.

One trial assessing colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)

Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.

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.

Number of patients with stomata bypass (preventive or therapeutic) at each time of follow-up after surgery (2SCA or CAA).

A stomata bypass is the result of a surgical operation in which a damaged part is removed from the ileum (ileostomy) or colon (colostomy) and the cut end diverted to an artificial opening in the abdominal wall.

Post-operative morbidity was assessed in terms number of patients with at least one surgical complications related to treatment and related to a serious adverse event.

Postoperative mortality was defined by the number of patients who deceased (all cause mortality) during the first 30 days after surgery (2SCA or CAA).

Progression-free survival (PFS) was defined as the time from the date of surgery and the date of the earliest of the following events:

* The patient's death, whatever the cause,
* Local progression or remotely.

Progression was defined as clinical or radioglogical progression. Radiological progression was defined Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"

1-year and 2-year progression-free rates were estimated.

The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20).

The rate of patients with anal incontinence (score \>=5) at 6 months was reported.

The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20).

The rate of patients with anal incontinence (score \>=5) at 12 months was reported.

The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20).

The rate of patients with anal incontinence (score \>=5) at 24 months was reported.

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. 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.

The effectiveness of the CAA surgery will be evaluated in terms of absence of fistula requiring stoma diversion. Similarly to 2SCA group, 53 CAA eligible and evaluable patients will be required. If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the CAA is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients CAA.

Institut Bergonié

Only Serious Adverse events were collected following NCI-CTCAE (3.0).

Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.

2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.

After surgical resection, the colon is exteriorized through the anus and attached to the buttock.

By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation

2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)

Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.

In the absence of fistula, the patient will reoperation for stoma closure of its branch

Colo-anal Anastomosis (CAA)

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

France

Region of Enrollment

Eligible patient (without major protocole deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively.

Pr Simone Mathoulin-Pelissier

Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure.

Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA

30 days

1 year

2 years

Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively.

Stomata Bypass (Preventive or Therapeutic)

Post-operative Morbidity

Postoperative Mortality

1-year PFS

2-years PFS

Progression-free Survival

Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively and who responded to the questionnaire.

Number of Participants With Anal Incontinence at 6 Months

Number of Participants With Anal Incontinence at 12 Months

Number of Participants With Anal Incontinence at 24 Months

Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.

In the absence of fistula, the patient will reoperation for stoma closure of its branch.

Eligible patient (without major protocol deviation) which was operated with complete CAA procedure.

Spots Global Cancer Trial Database for medium and lower rectal cancer