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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | standard care of patient with psychological and enterostomal therapy clinic if necessary |
|
| Optimal care | Experimental | Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Behavioral | Psychological & enterostomal therapy clinics on demand only |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yves PANIS, PhD, MD | Contact | yves.panis@bjn.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Yves PANIS | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Beaujon | Recruiting | Clichy | 92110 | France |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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 |
|
| at Day45, Day60, Day90 |
| Specific stoma related morbidity | at Day45, Day60, Day90 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |