Status:

UNKNOWN

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.

Lead Sponsor:

Instituto do Cancer do Estado de São Paulo

Conditions:

Rectal Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • Acute myocardial infarction (in the last 30 days) or Unstable angina.
  • Uncontrolled cardiac arrhythmia.
  • Symptomatic severe aortic stenosis or other symptomatic severe valve dysfunction.
  • Congestive heart failure NYHA III or IV.
  • Hemodynamic instability.
  • Venous thromboembolism.
  • Pericarditis, endocarditis or myocarditis.
  • Aortic dissection.
  • Septic shock.
  • Need for renal replacement therapy.
  • Thyrotoxicosis.
  • Presence of bone metastasis.
  • Osteomioarticular and neurological conditions that make it impossible to carry out the exercise program designed for this study.
  • Palliative procedures.
  • Inability to perform the exercises due to musculoskeletal or neurological changes.

Key Trial Info

Start Date :

March 9 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2022

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT04795609

Start Date

March 9 2020

End Date

July 1 2022

Last Update

March 12 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Caio Araujo

São Paulo, Brazil, 01246-000

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. | DecenTrialz