NCT01403883

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

November 30, 2010

Last Update Submit

January 15, 2015

Conditions

Cancer of Rectum

Keywords

Rectal cancerTemporary stomaPsychological disorders

Outcome Measures

Primary Outcomes (2)

  • Evolution of Global Quality of life (SF36)

    at Day45, Day0, Day45, Day60, Day90

  • Evolution of Psychological anxiety score (STAI/Beck)

    at Day-45, Day0, Day45, Day60, Day90

Secondary Outcomes (4)

  • 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

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

Behavioral: Standard Care

Optimal care

EXPERIMENTAL

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

Behavioral: Optimal care (Psychological and enterostomal therapy clinics)

Interventions

Standard CareBEHAVIORAL

Psychological \& enterostomal therapy clinics on demand only

Standard care
Optimal care (Psychological and enterostomal therapy clinics)BEHAVIORAL

Psychological clinics at D-45, D0, D45, D60, D90 enterostomal therapy clinics at D-45, D0, D45, D60

Optimal care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsMental Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Yves PANIS

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves PANIS, PhD, MD

CONTACT

yves.panis@bjn.aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

July 27, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

FR(1)