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

Phase 2
18 Years
75 Years
Open (Enrolling)
Medium and Lower Rectal Cancer

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Trial Information

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

Inclusion Criteria:

- Histologically proven rectal adenocarcinoma.

- Medium or lower rectum tumour requiring removal of the entire rectum and its

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Main objective is to evaluate effectiveness of delayed coloanal anastomosis (ACAD) in the medium and lower rectal cancer treatment,

Outcome Description:

The primary endpoint was the effectiveness of the ACAD surgery evaluated in terms of absence of fistula requiring stoma diversion. We wish to highlight that the rate of patients with a fistula requiring stoma diversion is less than 15%, that is to say that the effectiveness of the ACAD rate is higher than 85%. Based on a one-sided binomial test with the null and alternative hypotheses respectively 85% 95% 53 ACAD eligible and evaluable patients will be required (one-sided type I error of 5% and 80% power). If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the ACAD is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients ACAD.

Outcome Time Frame:

Delayed coloanal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation

Safety Issue:


Principal Investigator


Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié


FRANCE : French Agency for Sanitary Safety of Health Products

Study ID:




Start Date:

May 2010

Completion Date:

May 2016

Related Keywords:

  • Medium and Lower Rectal Cancer
  • Rectal cancer
  • Coloanal anastomosis
  • Phase 2 clinical trial
  • Rectal Neoplasms