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.

Instituto do Cancer do Estado de São Paulo

Status: Unknown

Conditions: Rectal Cancer

Treatments: Other: Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).

Study type: Interventional

Funder types: Other

Identifiers

NCT04795609

NP1561

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Interventional group

Active Comparator group

Description:

Early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care

Treatment:

Other: Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).

Control group

No Intervention group

Description:

Bed restriction strategy for 5 days