Psychological and Enterostomal Therapy Care

Not Applicable

• Conditions: Cancer of Rectum
• Interventions: Behavioral: Optimal care (Psychological and enterostomal therapy clinics); Behavioral: Standard Care

• Registration Number: NCT01403883
• Lead Sponsor: Association de Recherche Experimentale et Clinique en Chirurgie Digestive

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal care	Optimal care (Psychological and enterostomal therapy clinics)	Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up
Standard care	Standard Care	standard care of patient with psychological and enterostomal therapy clinic if necessary

Primary Outcome Measures

Name	Time	Method
Evolution of Psychological anxiety score (STAI/Beck)	at Day-45, Day0, Day45, Day60, Day90
Evolution of Global Quality of life (SF36)	at Day45, Day0, Day45, Day60, Day90

Secondary Outcome Measures

Name	Time	Method
Evolution of Specific stoma score and stoma care learning	at Day-45, Day0, Day45, Day60, Day90
Hospital stay	at Day90
Overall morbidity	at Day45, Day60, Day90
Specific stoma related morbidity	at Day45, Day60, Day90

Trial Locations

Locations (1)

Hôpital Beaujon; 🇫🇷 Clichy, France