NCT01876901

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Medium and Lower Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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

Timeline

• Start date: 2010-08-11
• Primary completion: 2017-05-09
• Completion: 2019-02-14
• First posted: 2013-06-13
• Last updated: 2025-09-04
• Results posted: 2021-08-04

Locations

9 sites across 1 country: France