Psychological and Enterostomal Therapy Care

Cancer of Rectum Clinical Trial

— PROSPER  

Official title:

Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01403883
• Other study ID #: UK10005
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2010
• Last updated: January 15, 2015
• Start date: October 2011
• Est. completion date: February 2015

Study information

• Verified date: January 2015
• Source: Association de Recherche Experimentale et Clinique en Chirurgie Digestive
• Contact: Yves PANIS, PhD, MD
• Email: yves.panis[@]bjn.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer of Rectum

Intervention

Behavioral:
• Standard Care
Psychological & enterostomal therapy clinics on demand only
• Optimal care (Psychological and enterostomal therapy clinics)
Psychological clinics at D-45, D0, D45, D60, D90 enterostomal therapy clinics at D-45, D0, D45, D60

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Association de Recherche Experimentale et Clinique en Chirurgie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of Global Quality of life (SF36)		at Day45, Day0, Day45, Day60, Day90	No
Primary	Evolution of Psychological anxiety score (STAI/Beck)		at Day-45, Day0, Day45, Day60, Day90	No
Secondary	Evolution of Specific stoma score and stoma care learning		at Day-45, Day0, Day45, Day60, Day90	No
Secondary	Hospital stay		at Day90	No
Secondary	Overall morbidity		at Day45, Day60, Day90	No
Secondary	Specific stoma related morbidity		at Day45, Day60, Day90	No