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| ID | Type | Description | Link |
|---|---|---|---|
| AMO nr. 04/074 |
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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.
This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not.
The research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before.
The aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INRA | Experimental | Patients treated for medical refractory Ulcerative Colitis |
|
| IPAA | Active Comparator | Patients treated for medical refractory Ulcerative Colitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ileal Neo Rectal Anastomosis | Procedure | Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis |
| Measure | Description | Time Frame |
|---|---|---|
| functional outcome | after surgery: 3 months, 6 months, 12 months and yearly afterwards | |
| Quality of life and Health Status | after surgery: 3 months, 6 months, 12 months and yearly afterwards |
| Measure | Description | Time Frame |
|---|---|---|
| histo-pathologic results | after surgery: 3 months, 6 months, 12 months and yearly afterwards | |
| endoscopic results | after surgery: 3 months, 6 months, 12 months and yearly afterwards | |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| JT Heikens, MD | St Elisabeth Hospital, Tilburg, The Netherlands | Principal Investigator |
| D de Jong, MD, PhD | University Medical Centre St Radboud, Nijmegen, The Netherlands | Study Chair |
| JLJM Teepen, MD, PhD | St Elisabeth Hospital, Tilburg, The Netherlands | Study Chair |
| JHJM van Krieken, MD, PhD | University Medical Centre St Radboud, The Netherlands | Study Chair |
| HG Gooszen, MD, PhD | University Medical Centre St Radboud, Nijmegen, The Netherlands | Study Chair |
| J de Vries, Md, PhD | St Elisabeth Hospital, Tilburg, The Netherlands | Study Chair |
| CJHM van Laarhoven, MD, PhD | University Medical Centre St Radboud, The Netherlands | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre St Radboud | Nijmegen | Gelderland | 6500 HB | Netherlands | ||
| St Elisabeth Hospital |
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| Ileal Pouch Anal Anastomosis | Procedure | Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis |
|
| morbidity and mortality |
| after surgery: 3 months, 6 months, 12 months and yearly afterwards |
| ano-rectal physiology | after surgery: 3 months, 6 months, 12 months and yearly afterwards |
| Tilburg |
| North Brabant |
| 5022 GC |
| Netherlands |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D016737 | Proctocolectomy, Restorative |
| ID | Term |
|---|---|
| D003082 | Colectomy |
| D000099090 | Surgical Procedures, Colorectal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000078542 | Proctectomy |
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