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"Cryotherapy", or cold therapy, can include the use of gel packs, ice bags, ice baths, whole body chambers, and cold aerosol sprays. It is a popular non-drug treatment that can be used after a surgical operation, along with medication such as narcotics and anti-inflammatories for pain management. The application of ice packs on areas of injury has been used for many decades, as they can decrease both inflammation and pain. Other possible benefits include reduced blood flow, swelling, and tissue damage as well as muscle spasms. While there is some evidence to suggest that the use of ice packs is beneficial, this has not yet been implemented into practice, nor do any guidelines recommend the use of ice packs for pain management in surgical patients. In this trial, adult patients undergoing scheduled thoracoabdominal or groin surgery will be randomly assigned to apply ice packs over the largest closed surgical incision every 4 hours, at minimum, for 72 hours (while the patient is awake), along with standard of care, or to receive standard of care only. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest are quality of patient recovery, pain, length of hospital stay and medication use.
Background/rationale: To date, there is some evidence to suggest a benefit of cryotherapy application over closed post-operative incisions, however, this has not yet been implemented into practice. Furthermore, there are no clinical practice guidelines that recommend the application of cryotherapy for adjuvant pain management. Relevant randomized controlled trials (RCTs) in abdominal surgery demonstrate a possible advantage of cryotherapy application, when compared to no cryotherapy application. However, those RCTs were small and were restricted to gynecology procedures or emergent procedures. Therefore, the investigators aim to address this knowledge gap by assessing the benefit of applying cryotherapy post-operatively (along with standard of care approaches), compared to no cryotherapy, (i.e., standard of care, only) over closed incisions, across broad surgical specialties and procedures, to improve the quality of patient recovery in adult patients.
Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives:
Study design: This is a multicentre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial. Patients will be randomized to cryotherapy application or no cryotherapy application. If feasibility is demonstrated during the pilot trial, the investigators will plan to conduct a definitive trial. If there are only minimal changes to the protocol, the investigators will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy | Experimental | Cold therapy |
|
| No cryotherapy | No Intervention | Standard practices for pain management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Other | Application of cryotherapy (e.g. ice in resealable zipper storage bags, gel packs, ice packs) over largest closed incision in the post-operative period every 4 hours, at minimum, for up to 72 hours (while participant is awake and admitted to hospital). The cryotherapy should not be placed in direct contact with skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of accrual (one year) | Average number of patients enrolled per month across the 3 sites for the trial: feasible if 10 or more | 1 year |
| Proportion of participants who received the allocated intervention, across all sites | Feasible if >90% of patients receive correct intervention | 1 year |
| Proportion of complete data collection for patient-reported outcome surveys, across all sites | Feasible if >80% of data is collected | 1 year |
| Proportion of successful data linkage of patient-reported outcome data with Institute of Clinical Evaluative Sciences and National Surgical Quality Improvement Program dataset(s), across all sites | Feasible if linkage is possible in >90% of patients | 1 year |
| Estimation of Quality of Recovery (QoR) in patients treated with cryotherapy vs. no cryotherapy | Quality of patient recovery will be measured using the QoR-15 score at post-operative day 1 (POD1). The QoR-15 score ranges from 0-150 (the higher the score, the better the recovery). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Karanicolas, MD PhD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North York General Hospital | North York | Ontario | M2K 1E1 | Canada | ||
| The Ottawa Hospital |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Multi-centre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial
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|
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |