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Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.
The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Krankenhaus Nordwest Concept | Experimental | specific preoperative education program realised by a specialized stoma-therapist containing individualized information on material maintenance, hygiene, nutrition, complications, activities of daily life and occupation |
|
| Standard concept | Experimental | standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education program | Other | Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points | 9-15 days after surgery |
| Quality of Life | Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points | 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Period of hospitalization | 9-15 days after surgery, 4 weeks after surgery | |
| Complication rates | 9-15 days after surgery, 4 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Berkhoff, MD | Contact | +49697601 | 4016 | berkhoff.stefan@khnw.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Nordwest | Recruiting | Frankfurt | 60488 | Germany |
No IPD will be shared
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Sana Klinikum | Recruiting | Offenbach | 63069 | Germany |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011314 | Preventive Health Services |