Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study
The aim of the study is to asses the benefit of an optimal and specific care concerning the
temporary stoma in patients operated for rectal cancer surgery in term of psychological and
enterostomal therapy effect.
This study is a monocentric and randomized trial.
- Age > 18 y
- Rectal adenocarcinoma (tumor height < 15 cm from the anal verge) with or without pre
- Open or laparoscopic rectal excision with partial or total meso rectal excision with
sphincter preservation by colo rectal or colo anal anastomosis.
- Temporary stoma.
- Patient consent
- Patient with national health affiliation
- Stage IV disease with synchronous hepatic or pulmonary metastases
- Colonic cancer > 16 cm
- Associated surgical procedure (Hepatic resection, small bowel resection subtotal
- Abdominal perineal resection
- Associated comorbidity
- Emergency surgery
- Psychological care refusal
Type of Study:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Evolution of Global Quality of life (SF36)
Outcome Time Frame:
at Day45, Day0, Day45, Day60, Day90
France: Ministry of Health
- Cancer of Rectum
- Rectal cancer
- Temporary stoma
- Psychological disorders
- Rectal Neoplasms