A Phase 2 interventional study of Shared Decision Making using a Patient Decision Aid. in Shared Decision Making, Colonic Polyp and Decision Aids, sponsored by Vejle Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Vejle Hospital · Phase 2, Interventional, and Supportive care
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 110 is below the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Vejle Hospital is the lead sponsor of 95 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care.
Other: Shared Decision Making using a Patient Decision Aid.
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.
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.
Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.
Time frame: 30 days
Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.
Time frame: 45 days
Number of patients with postoperative morbidity 30 days after surgery
Time frame: 30 days postoperatively
Number of patients with postoperative mortality 30 days after surgery
Time frame: 30 days postoperatively
Number of patients with postoperative morbidity 90 days after surgery
Time frame: 90 days postoperatively
Number of patients with postoperative mortality 90 days after surgery
Time frame: 90 days postoperatively
Number of patients with recurrence 3 years after cancer diagnosis
Time frame: 3 years
Overall survival 3 years after cancer diagnosis
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after clinical encounter
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Vejle Hospital