Psychological and Enterostomal Therapy Care (PROSPER)

Association de Recherche Experimentale et Clinique en Chirurgie Digestive

Status: Unknown

Conditions: Cancer of Rectum

Treatments: Behavioral: Optimal care (Psychological and enterostomal therapy clinics); Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01403883

UK10005

Details and patient eligibility

About

In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard care

Active Comparator group

Description:

standard care of patient with psychological and enterostomal therapy clinic if necessary

Treatment:

Behavioral: Standard Care

Optimal care

Experimental group

Description:

Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up

Treatment:

Behavioral: Optimal care (Psychological and enterostomal therapy clinics)