Psychological and Enterostomal Therapy Care

Study Overview
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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.

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

Conditions
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Cancer of Rectum

Intervention / Treatment
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* Behavioral: Standard Care
* Behavioral: Optimal care (Psychological and enterostomal therapy clinics)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>standard care of patient with psychological and enterostomal therapy clinic if necessary | Behavioral: Standard Care<br>* Psychological & enterostomal therapy clinics on demand only<br>|
| Experimental: Optimal care<br>Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up | Behavioral: Optimal care (Psychological and enterostomal therapy clinics)<br>* Psychological clinics at D-45, D0, D45, D60, D90 enterostomal therapy clinics at D-45, D0, D45, D60<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Temporary stoma, Psychological disorders