Psychological and Enterostomal Therapy Care

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01403883

Acronym

PROSPER

Enrollment

Registered

2011-07-27

Start date

2011-10-31

Completion date

2015-02-28

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Rectum

Keywords

Rectal cancer, Temporary stoma, Psychological disorders

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.

Interventions

BEHAVIORALStandard Care

Psychological & enterostomal therapy clinics on demand only

BEHAVIORALOptimal care (Psychological and enterostomal therapy clinics)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Contacts

Primary ContactYves PANIS, PhD, MD

yves.panis@bjn.aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026