The goal of this clinical trial is to evaluate whether a wearable-enabled prehabilitation and rehabilitation pathway can improve recovery and post-operative outcomes in adults undergoing surgery for pancreatic cancer or related pancreatic/periampullary conditions.
The main questions it aims to answer are:
Does a wearable-enabled prehabilitation and rehabilitation programme reduce post-operative complications within 30 and 90 days after surgery? Is the use of wearable devices and remote monitoring feasible, acceptable, and useful for patients and healthcare professionals during the perioperative pathway?
Researchers will compare patients receiving the wearable-enabled pathway with a matched historical control group who received standard care to determine whether the intervention is associated with improved surgical and recovery outcomes.
Participants will:
Provide informed consent and complete baseline assessments and questionnaires. Take part in the Greater Manchester Prehab4Cancer programme before surgery, including personalised exercise, nutritional support, and wellbeing support.
Wear a Corsano CardioWatch device to continuously monitor physiological and activity data.
Use home monitoring equipment, including weight scales and blood pressure monitoring devices.
Complete questionnaires and participant logs during prehabilitation and recovery.
Receive regular support from the research team during participation. Undergo pancreatic surgery and receive standard NHS perioperative care. Continue wearable monitoring and rehabilitation after hospital discharge. Be followed for up to 12 months after surgery using routine clinical data to assess recovery, complications, hospital utilisation, and survival.
Optionally participate in a focus group to discuss their experiences of wearable-enabled care.
Adult patients aged 18 years or older.
Able to provide informed consent.
Able to use the study devices independently or with support from a carer.
Clinically stable and considered suitable to participate in the prehabilitation and rehabilitation programme.
Unable or unwilling to provide informed consent.
Lacks capacity to provide informed consent.
Unstable angina pectoris.
Recent myocardial infarction.
Parallel
Corsano CardioWatch
DeviceA wearable monitoring device used throughout the perioperative pathway to collect continuous physiological and activity data, including measures such as physical activity, heart rate, respiratory rate, oxygen saturation, skin temperature, and sleep-related metrics.
Prehab4Cancer Programme
BehavioralA personalised prehabilitation and rehabilitation programme comprising exercise, nutritional support, and wellbeing support delivered before and after pancreatic surgery.
Post-operative complications
Occurrence of post-operative complications following pancreatic surgery.
All-cause mortality
All-cause mortality post-surgery
Days Alive and Out of Hospital (DAOH)
Number of days participants are alive and not admitted to hospital during the preoperative period (from enrolment to surgery) and during the postoperative recovery period. DAOH incorporates mortality, length of stay, and hospital readmissions into a single patient-centred outcome measure.
Length of Stay
Number of days spent in hospital during the index surgical admission following pancreatic resection.
Completeness of Wearable Data Collected via Corsano CardioWatch
Percentage of expected physiological and activity data points (heart rate, SpO2, activity, sleep) successfully captured and transmitted, relative to the total expected monitoring period. Unit: percentage
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Manchester University NHS Foundation Trust
Lead sponsor
Medtronic
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
