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Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
CHU DE BORDEAUX - Hôpital Saint André
Bordeaux, Aquitaine, France
Institut Bergonié
Bordeaux, Aquitaine, France
CHU de GRENOBLE
Grenoble, Auvergne-Rhône-Alpes, France
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France
HOSPICES CIVILS DE LYON - Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, France
Clinique Du Tonkin
Villeurbanne, Auvergne-Rhône-Alpes, France
Institut Paoli Calmettes
Marseille, Bouche Du Rhône, France
Chu de Nancy
Nancy, Lorraine, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, Lorraine, France
Start Date
August 11, 2010
Primary Completion Date
May 9, 2017
Completion Date
February 14, 2019
Last Updated
September 4, 2025
124
ACTUAL participants
2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)
PROCEDURE
Colo-anal anastomosis (CAA)
PROCEDURE
Lead Sponsor
Institut Bergonié
Data Source & Attribution
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