Psychological and Enterostomal Therapy Care (PROSPER)

January 15, 2015 updated by: Association de Recherche Experimentale et Clinique en Chirurgie Digestive

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clichy, France, 92110
        • Recruiting
        • Hopital Beaujon
        • Contact:
        • Principal Investigator:
          • Frédéric Bretagnol, PhD-MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care
standard care of patient with psychological and enterostomal therapy clinic if necessary
Behavioral: Standard Care
Psychological & enterostomal therapy clinics on demand only
Experimental: Optimal care
Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of Specific stoma score and stoma care learning
Time Frame: at Day-45, Day0, Day45, Day60, Day90
at Day-45, Day0, Day45, Day60, Day90
Hospital stay
Time Frame: at Day90
at Day90
Overall morbidity
Time Frame: at Day45, Day60, Day90
at Day45, Day60, Day90
Specific stoma related morbidity
Time Frame: at Day45, Day60, Day90
at Day45, Day60, Day90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association de Recherche Experimentale et Clinique en Chirurgie Digestive

Investigators

  • Principal Investigator: Yves PANIS, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UK10005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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