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


N/A
18 Years
75 Years
Not Enrolling
Both
Cancer of Rectum

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Evolution of Global Quality of life (SF36)

Outcome Time Frame:

at Day45, Day0, Day45, Day60, Day90

Safety Issue:

No

Principal Investigator

Frédéric Bretagnol

Investigator Role:

Principal Investigator

Investigator Affiliation:

AP-HP

Authority:

France: Ministry of Health

Study ID:

UK10005

NCT ID:

NCT01403883

Start Date:

July 2011

Completion Date:

September 2011

Related Keywords:

  • Cancer of Rectum
  • Rectal cancer
  • Temporary stoma
  • Psychological disorders
  • Rectal Neoplasms

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