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| ID | Type | Description | Link |
|---|---|---|---|
| 15/LO/1038 | Other Identifier | NRES London City Road & Hampstead |
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This is an observational study, which aims to assess how physical activity levels following surgical procedures correlate with patient recovery and length of hospital stay, as well as the utility of this physical activity data to the postoperative surgical team. Surgical teams frequently enquire about their patients' physical activity levels on postoperative ward rounds. Although this information is often provided anecdotally by nursing staff and junior doctors, there are no objective data made available to the clinician. Such data has the potential to supplement other observations (e.g. heart rate, blood pressure, temperature) to help gain an impression of a patient's recovery and physical status, this in turn could provide evidence to help facilitate early discharge as well as to predict medium to longterm outcomes. Advances in wearable technology allow the investigators to collect detailed information with regard to activity with minimal disruption.
Recent literature has shown that these wristworn sensors can feasibly be worn in hospital pre and postoperatively, with evidence of a correlation between the amount of steps taken postoperatively and the length of hospital stay. This study will provide further evidence for the usability and utility of wearable sensors in the inpatient surgical setting. It will provide supporting evidence for surgeons to confidently analyse and assess patients in hospital, allowing for safe and expedient discharge home as well as identify highrisk patients who are likely to require extra support and surveillance in the community setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity sensor (3 axis accelerometer) | Device | Patient cohort will wear the activity sensor from pre-admission clinic until discharge after surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total Activity Pre-op | 2-3 weeks | |
| Length of Hospital Stay | hospital stay (through hospital stay, approximately to 35 days) | |
| Time Spent in Light Activity - Pre-op | Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed. | 2-3 weeks |
| Time Spent in Moderate Activity - Preop | Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed. | 2-3 weeks |
| Time Spent in Vigorous Activity - Pre-op | Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed. | 2-3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Re-admission at Day 30 | 30 days after surgery | |
| Number of Participants With Complications up to 6 Weeks Post Discharge | up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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patients due for elective surgical procedures will be recruited from outpatient general surgical clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mary's Hospital | London | Not in US/Canada | W2 1NY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Cohort | Normal healthy cohort not undergoing colorectal surgical management |
| FG001 | Patients Wearing WAM Pre-op and Post-op on the Ward | Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge |
| FG002 | Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Only 28 patients in the Pre-op/post-op group completed the study, 10 participants did not have full data available for analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Cohort | Normal healthy cohort not undergoing colorectal surgical management |
| BG001 | Patients Wearing WAM Pre-op and Post-op on the Ward | Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Activity Pre-op | Posted | Mean | Standard Deviation | minutes of activity per 24 hour period | 2-3 weeks |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Cohort | Normal healthy cohort not undergoing colorectal surgical management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Aliza Abeles | Imperial College London | 07834987667 | aliza.abeles@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2016 | Feb 16, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2016 | Feb 16, 2021 | ICF_001.pdf |
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| BG002 | Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
|
|
| Primary | Length of Hospital Stay | Posted | Median | Full Range | days | hospital stay (through hospital stay, approximately to 35 days) |
|
|
|
| Primary | Time Spent in Light Activity - Pre-op | Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed. | Posted | Mean | Standard Deviation | minutes of activity per 24 hour period | 2-3 weeks |
|
|
|
| Primary | Time Spent in Moderate Activity - Preop | Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed. | Posted | Mean | Standard Deviation | minutes of activity per 24 hour period | 2-3 weeks |
|
|
|
| Primary | Time Spent in Vigorous Activity - Pre-op | Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed. | Posted | Mean | Standard Deviation | minutes of activity per 24 hour period | 2-3 weeks |
|
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| Secondary | Number of Participants With Re-admission at Day 30 | Posted | Count of Participants | Participants | 30 days after surgery |
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| Secondary | Number of Participants With Complications up to 6 Weeks Post Discharge | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Patients Wearing WAM Pre-op and Post-op on the Ward | Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Male |
|