Effect of a Post-operative Protocol of Early Mobilization on Functional Recovery and Postoperative Complications After Immediate Internal Pudendal Artery Perforator Flap Reconstruction for Irradiated Abdominoperineal Resection Defects: a Prospective, Randomized and Controlled Clinical Study.
NCT ID: NCT04795609
Last Updated: 2021-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2020-03-09
2022-07-01
Brief Summary
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We will perform a open label, parallel-arm, randomized trial in patients who underwent immediate internal pudendal artery perforator flap reconstruction for irradiated abdominoperineal resection defects in a tertiary university hospital.
Patients will be randomized to an early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care - bed restriction for 5 days. The primary outcome will be inability to walk without human assistance at postoperative day 5 or hospital discharge.The secondary outcomes will be incidence of surgical complications, ability of walk assessed for the 6-minute walk test, incidence and intensity of fatigue measured by Piper's Revised Fatigue Scale, improvement of quality of life measured by EuroQuol-5D-5L Questionnaire, Incidence of deep venous thrombosis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional group
Early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care
Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
1. Trunk control.
2. Orthostatism.
3. Walk training.
4. Aerobic exercises.
5. Muscle strengthening.
Control group
Bed restriction strategy for 5 days
No interventions assigned to this group
Interventions
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Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
1. Trunk control.
2. Orthostatism.
3. Walk training.
4. Aerobic exercises.
5. Muscle strengthening.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Agreement to participate and signature of the informed consent form by the patient and / or family.
Exclusion Criteria
2. Uncontrolled cardiac arrhythmia.
3. Symptomatic severe aortic stenosis or other symptomatic severe valve dysfunction.
4. Congestive heart failure NYHA III or IV.
5. Hemodynamic instability.
6. Venous thromboembolism.
7. Pericarditis, endocarditis or myocarditis.
8. Aortic dissection.
9. Septic shock.
10. Need for renal replacement therapy.
11. Thyrotoxicosis.
12. Presence of bone metastasis.
13. Osteomioarticular and neurological conditions that make it impossible to carry out the exercise program designed for this study.
14. Palliative procedures.
15. Inability to perform the exercises due to musculoskeletal or neurological changes.
18 Years
ALL
No
Sponsors
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Instituto do Cancer do Estado de São Paulo
OTHER
Responsible Party
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Locations
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Caio Araujo
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Caio Araujo, MD
Role: primary
Other Identifiers
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NP1561
Identifier Type: -
Identifier Source: org_study_id
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