Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)
Condition: Medium and Lower Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA); Colo-anal anastomosis (CAA)
Intervention description: 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; 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rectal cancer; Coloanal anastomosis; Phase 2 clinical trial

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 .

          -  ASA ≤ 2.

          -  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

        Exclusion Criteria:

          -  Other histology of rectal cancer.

          -  T1 N0 or T2 N0 or T4 tumour.

          -  Metastatic disease M1.

          -  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.