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Psychological and Enterostomal Therapy Care (PROSPER)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Association de Recherche Experimentale et Clinique en Chirurgie Digestive.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Association de Recherche Experimentale et Clinique en Chirurgie Digestive
ClinicalTrials.gov Identifier:
NCT01403883
First received: November 30, 2010
Last updated: January 15, 2015
Last verified: January 2015
  Purpose
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.

Condition Intervention
Cancer of Rectum Behavioral: Standard Care Behavioral: Optimal care (Psychological and enterostomal therapy clinics)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study

Further study details as provided by Association de Recherche Experimentale et Clinique en Chirurgie Digestive:

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

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

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403883

Contacts
Contact: Yves PANIS, PhD, MD yves.panis@bjn.aphp.fr

Locations
France
Hôpital Beaujon Recruiting
Clichy, France, 92110
Contact: Frederic Bretagnol, PhD-MD       frederic.bretagnol@bjn.aphp.fr   
Principal Investigator: Frédéric Bretagnol, PhD-MD         
Sponsors and Collaborators
Association de Recherche Experimentale et Clinique en Chirurgie Digestive
Investigators
Principal Investigator: Yves PANIS Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Association de Recherche Experimentale et Clinique en Chirurgie Digestive
ClinicalTrials.gov Identifier: NCT01403883     History of Changes
Other Study ID Numbers: UK10005
Study First Received: November 30, 2010
Last Updated: January 15, 2015

Keywords provided by Association de Recherche Experimentale et Clinique en Chirurgie Digestive:
Rectal cancer
Temporary stoma
Psychological disorders

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 21, 2017