Major abdominal oncology surgery is associated with substantial postoperative loss of functional capacity, and exercise may be an effective intervention to improve outcomes. The aim of this study was to assess efficacy, feasibility and safety of a supervised postoperative exercise programme in patients undergoing immediate internal pudendal artery perforator flap reconstruction for irradiated abdominoperineal resection defects. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
Caio Araujo
São Paulo, Brazil
RECRUITINGCapacity of functional walking.
Capacity of functional walking, assessed by the patient's ability to cross the hospital room or the ability to walk 3 meters independently on the 5th postoperative day.
Time frame: 5 days.
Hospital stay.
Hospital Stay.
Time frame: 30 days.
Postoperative complications.
Incidence of postoperative complications using the Clavien-Dindo classification.
Time frame: 30 days.
Functional walking capacity, assessed by the 6-minute walk test.
Functional walking capacity, assessed by the 6-minute walk test.
Time frame: 30 days.
Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
Time frame: 30 days.
Quality of life measured by the EuroQol-5D-5L Questionnaire.
Quality of life measured by the EuroQol-5D-5L Questionnaire.
Time frame: 30 days.
Incidence of deep venous thrombosis.
Incidence of deep venous thrombosis.
Time frame: 30 days.
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