Clinical trial NCT04795609: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection .
2. Age ≥ 18 years.
3. Agreement to participate and signature of the informed consent form by the patient and / or family.

Exclusion Criteria:

1. Acute myocardial infarction (in the last 30 days) or Unstable angina.
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.

Primary outcomes:
measure: Capacity of functional walking.
timeFrame: 5 days.
Secondary outcomes:
measure: Hospital stay.
timeFrame: 30 days.
measure: Postoperative complications.
timeFrame: 30 days.
measure: Functional walking capacity, assessed by the 6-minute walk test.
timeFrame: 30 days.
measure: Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
timeFrame: 30 days.
measure: Quality of life measured by the EuroQol-5D-5L Questionnaire.
timeFrame: 30 days.
measure: Incidence of deep venous thrombosis.
timeFrame: 30 days.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Caio Araujo
Study officials:
References: