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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Helse Nord-Trøndelag HF | OTHER |
| St. Olavs Hospital |
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The Norwegian Stoma Trial is an open-label multicenter trial investigating the use of stomas, both diveriting and permanent, in the surgical treatment of rectal cancer. The objective is to compare the chosen strategy to surgical complications, health realted quality of life and length of stay.
In this national, multicenter study the study group will investigate whether patients with rectal adenocarcinoma undergoing a resection with an anastomosis will benefit from a diverting stoma or not, by studying how choice of surgery affects complications. In addition the study group will investigate complication rates and HRQoL among patients receiving a permanent colostomy and compare this to patients who have received an anastomosis. The investigators know that there are different approaches to the use of stomas (both permanent and diverting) between different hospitals. The investigators aim to discover potential differences in complication rates, length of stay and HRQoL among these patients and compare this to the chosen strategy. Health related quality of life will be measured using the EORTC CR 29 and EORTC CR 30 questionnares. Bowel function will also be monitored using the LARS (low anterior resection syndrome) score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal resection with diverting stoma | Patients operated for rectal cancer with rectal resection and diverting stoma. |
| |
| Rectal resection without diverting stoma | Patients operated for rectal cancer with rectal resection without diverting stoma. |
| |
| Rectal resection with primary colostomy | Patients operated for rectal cancer with rectal resection with primary colostomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal resection with diverting stoma | Procedure | Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications graded as Accordion grade 3 or more | The study group will investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have higher complication rates compared to patients who do not recieve a diverting stoma. | Measured one year after the primary surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total length of hospital stay | Number of days admitted at hospital. The study group will investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have a higher number of days admitted to hospital compared to patients who do not recieve a diverting stoma. | Measured one year after the primary surgery |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients undergoing a formal resection for rectal cancer will be asked to participate as long as they fit the eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Thomas Seeberg, MD, PhD | Contact | +4733342000 | ltseeberg@gmail.com | |
| Lars Grønvold, MD | Contact | +4733342000 | lagr1@siv.no |
| Name | Affiliation | Role |
|---|---|---|
| Lars Thomas Seeberg, MD, PhD | The Hospital of Vestfold | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asker og Baerum Hospital | Recruiting | Bærums verk | Gjettum | 1346 | Norway |
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| OTHER |
| Alesund Hospital | OTHER |
| Helse Fonna | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| Sorlandet Hospital HF | OTHER_GOV |
| Sykehuset Telemark | OTHER_GOV |
| Vestre Viken Hospital Trust | OTHER |
| Asker & Baerum Hospital | OTHER |
| Ullevaal University Hospital | OTHER |
| Oslo University Hospital | OTHER |
| Ostfold Hospital Trust | OTHER |
| University Hospital, Akershus | OTHER |
| Hamar Hospital | UNKNOWN |
| Gjøvik Hospital | UNKNOWN |
| Bodø Hospital | UNKNOWN |
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| Rectal resection without diverting stoma | Procedure | Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created |
|
| Rectal resection with permanent colostomy | Procedure | Patients in this group will receive a rectal resection and a permanent colostomy will be created |
|
| Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire | Generic health related quality of life is measured using the EORTC C30 questionnaire. Investigate whether patients receiving a rectal resection with a primary colostomy have poorer health related quality of life compared to patients receiving an anastomosis. | One year after the primary surgery |
| Bowel function measured by the Low Anterior Resection Syndrome (LARS) score | Bowel function is measured using the Low Anterior Resection Syndrome score. The score ranges from 0 to 42 points The higher the score, the worse the bowel function. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have higher LARS scores compared to patients who do not recieve a diverting stoma. | One year after the primary surgery |
| Surgical complications graded as Accordion grade 3 or more | Investigate whether patients receiving a rectal resection with a primary colostomy have lower complication rates compared to patients receiving an anastomosis | Measured one year after the primary surgery |
| Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire. | Generic health related quality of life is measured using the EORTC C30 questionnaire. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have poorer health related quality of life compared to patients who do not recieve a diverting stoma. | One year after the primary surgery |
| Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire | Disease specific health related quality of life measured by the EORTC CR29 questionnnaire. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have poorer health related quality of life compared to patients who do not recieve a diverting stoma. | One year after the primary surgery |
| Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire. | Disease specific health related quality of life measured by the EORTC CR29 questionnnaire. Investigate whether patients receiving a rectal resection with a primary colostomy have poorer health related quality of life compared to patients receiving an anastomosis. | One year after the primary surgery |
| Østfold Hospital Trust | Recruiting | Sarpsborg | Grålum | 1714 | Norway |
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| Akershus University Hospital | Recruiting | Oslo | Lørenskog | 1478 | Norway |
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| Ålesund Hospital | Recruiting | Ålesund | 6017 | Norway |
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| Haukeland University Hospital | Recruiting | Bergen | 5009 | Norway |
|
| Bodø Hospital | Recruiting | Bodø | 8005 | Norway |
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| Vestre Viken Hospital Trust | Recruiting | Drammen | 3004 | Norway |
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| Gjøvik Hospital | Recruiting | Gjøvik | 2819 | Norway |
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| Hamar Hospital | Recruiting | Hamar | 2318 | Norway |
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| Helse Fonna | Recruiting | Haugesund | 5528 | Norway |
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| Sorlandet Hospital HF | Recruiting | Kristiansand | 4615 | Norway |
|
| Helse Nord-Trøndelag HF | Recruiting | Levanger | 7600 | Norway |
|
| Ullevaal University Hospital | Recruiting | Oslo | 0450 | Norway |
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| Sykehuset Telemark | Recruiting | Skien | 3710 | Norway |
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| Helse Stavanger HF | Recruiting | Stavanger | 4019 | Norway |
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| University Hospital of North Norway | Recruiting | Tromsø | 9019 | Norway |
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| St. Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
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| Vestfold Hospital Trust | Recruiting | Tønsberg | 3103 | Norway |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078542 | Proctectomy |
| ID | Term |
|---|---|
| D000099090 | Surgical Procedures, Colorectal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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