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Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy.
Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process.
This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared Decision Making (SDM) | Experimental | Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care. |
|
| Historical data arm | No Intervention | Historical data on the management of patients with an unexpected malignant colorectal polyp from February 2018 to the end of 2022 retrieved through the Danish Colorectal Cancer Group Database, the National Pathology database and the National Patient Register. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision Making using a Patient Decision Aid. | Other | The intervention comprises the surgeon actively using the tailored PtDA and SDM with the patient when deciding on the management of an unexpected malignant colorectal polyp. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data. | 45 days | |
| Number of patients with postoperative morbidity 30 days after surgery | 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helene Würtz, MD | Contact | +4579405623 | helene.juul.wurtz3@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Helene Würtz, MD | Vejle Hospital, Center for Shared Decision Making and Surgical Department | Principal Investigator |
| Karina D Steffensen, Prof PhD MD | Center For Shared Decision Making, Vejle Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37963688 | Derived | Wurtz HJ, Rahr HB, Lindebjerg J, Edwards A, Steffensen KD. Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study. BMJ Open. 2023 Nov 14;13(11):e073900. doi: 10.1136/bmjopen-2023-073900. |
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The study is a clinical multicenter, non-randomized, interventional phase II study. Three to five departments of colorectal surgery in Danish hospitals will be invited to participate in the study.
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| Number of patients with postoperative mortality 30 days after surgery | 30 days postoperatively |
| Number of patients with postoperative morbidity 90 days after surgery | 90 days postoperatively |
| Number of patients with postoperative mortality 90 days after surgery | 90 days postoperatively |
| Number of patients with recurrence 3 years after cancer diagnosis | 3 years |
| Overall survival 3 years after cancer diagnosis | 3 years |
| Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. | Score range 1-100. The higher the score, the better the quality of life. | 24 hours after clinical encounter |
| Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. | Score range 1-100. The higher the score, the better the quality of life. | 3 months after clinical encounter |
| Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire. | Score range 1-100. The higher the score, the better the quality of life. | 6 months after clinical encounter |
| Hans B Rahr, Prof Dr MD | Surgical Department, Vejle Hospital | Study Chair |
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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