Trial Information
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.
Inclusion Criteria:
- Age > 18 y
- Rectal adenocarcinoma (tumor height < 15 cm from the anal verge) with or without pre
operative radiochemotherapy.
- 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
Exclusion Criteria:
- Stage IV disease with synchronous hepatic or pulmonary metastases
- Colonic cancer > 16 cm
- Associated surgical procedure (Hepatic resection, small bowel resection subtotal
colectomy)
- Abdominal perineal resection
- Associated comorbidity
- Emergency surgery
- Psychological care refusal
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Evolution of Global Quality of life (SF36)
Outcome Time Frame:
at Day45, Day0, Day45, Day60, Day90
Safety Issue:
No
Principal Investigator
Frédéric Bretagnol
Investigator Role:
Principal Investigator
Investigator Affiliation:
AP-HP
Authority:
France: Ministry of Health
Study ID:
UK10005
NCT ID:
NCT01403883
Start Date:
July 2011
Completion Date:
September 2011
Related Keywords:
- Cancer of Rectum
- Rectal cancer
- Temporary stoma
- Psychological disorders
- Rectal Neoplasms