Psychological and Enterostomal Therapy Care

NCT ID: NCT01403883

Last Updated: 2015-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Cancer of Rectum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard care

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

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Psychological \& enterostomal therapy clinics on demand only

Optimal care

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

Group Type EXPERIMENTAL

Optimal care (Psychological and enterostomal therapy clinics)

Intervention Type BEHAVIORAL

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

Interventions

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Standard Care

Psychological \& enterostomal therapy clinics on demand only

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association de Recherche Experimentale et Clinique en Chirurgie Digestive

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves PANIS

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Beaujon

Clichy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yves PANIS, PhD, MD

Role: CONTACT

Facility Contacts

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Frederic Bretagnol, PhD-MD

Role: primary

Other Identifiers

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UK10005

Identifier Type: -

Identifier Source: org_study_id

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