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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
110
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
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