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Effect of Impulsive Compression Treatment on Postoperative Complications After Open Peripheral Vascular
Tenna Klit1, Marie Dahl2, Kim Christian Houlind1
1Department of Vascular Surgery, Hospital Lillebaelt, University of Southern Denmark, Kolding, Denmark.
Insights
This study investigates if a foot pump can reduce leg swelling after critical leg ischemia (CLI) surgery. Early results suggest it may improve patient recovery and quality of life.
Area of Science:
- Vascular Surgery
- Medical Device Technology
- Postoperative Care
Background:
- Critical leg ischemia (CLI) necessitates lower extremity bypass surgery.
- Postoperative complications, primarily edema, affect 18% of patients, prolonging recovery.
- Preventing edema through early mobilization or venous pump stimulation is crucial.
Purpose of the Study:
- To assess if compression therapy with a foot pump reduces postoperative edema.
- To evaluate the impact on wound healing, ischemic ulcer healing, and hospitalization duration.
- To determine improvements in patients' subjective quality of life.
Main Methods:
- A randomized, unblinded prospective study comparing standard care with foot pump therapy.
- 50 patients per group, with edema measured at specific leg points preoperatively and postoperatively.
- Quality of life assessed using EQ-5D and VascuQol-6 questionnaires.
Main Results:
- Primary endpoint: at least 50% reduction in leg edema.
- Secondary endpoints: earlier patient mobilization and shorter hospital stays.
- Quality of life improvements measured by validated questionnaires.
Conclusions:
- Foot pumps have demonstrated efficacy in reducing edema and thrombosis in orthopedic surgery patients.
- This study is the first to investigate foot pump use in vascular patients undergoing bypass surgery.
- Further research is needed as no prior meta-analyses exist for this specific application.
Background:
In patients with critical leg ischemia (CLI), the standard operative choice is an in situ bypass to the lower extremity to improve the patients´ prognosis and quality of life. Postoperative complications after surgery occur in 18 % of the patients, prolonging hospitalization and convalescence. The main operative complication is edema. This can be prevented by early mobilization or stimulation of the natural venous pump in the leg.
Objective:
To investigate whether compression therapy with foot pump reduces postoperative edema, facilitates wound healing of the operation wounds, promotes healing of ischemic ulcers, and shortens hospitalization, increasing and improving the patient's subjective quality of life faster.
Methods:
The protocol is designed as a randomized, unblinded prospective study with 50 patients in each group. Standard postoperative routines after bypass surgery, including short-stretch bandaging of the operated legs, are compared to supportive stimulation of the venous pump by an impulsive compression foot pump. The postoperative edema of the leg is measured 10 cm below the patella and 8 cm proximal to the medial malleolus. Measurements are performed preoperatively, 1 and 4 days postoperatively and at discharge.
Results:
The primary endpoint is reduction of leg edema by at least 50%. The secondary endpoint includes earlier mobilization in the pump group and decreased length of stay in hospital. Quality of life is evaluated through the European Health Related Quality of Life Questionnaire 5 Dimensions (EQ-5D) and Vascular Quality of Life Questionnaire-6 (VascuQol-6) questionnaires. The start of the study is February 1, 2018, and the end of the study is February 1, 2020. First results will be available April 2020.
Conclusions:
In orthopedic surgery of the lower extremities, the use of foot pumps has shown a reduction of edema and thrombosis in risk patients. Although important positive effects may be expected after vein bypass surgery, no reports have yet investigated the use of the device in vascular-operated patients and no analysis or meta Cochrane reviews are available in this field.
Trial Registration:
ClinicalTrials.gov NCT03192982; https://clinicaltrials.gov/ct2/show/NCT03192982 (Archived by WebCite at http://www.webcitation.org/6xMZJ06dw).
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