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.

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 Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caio Araujo, MD; Phone Number: +5511973692436; Email: caio.araujo@hc.fm.usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-000
    • Recruiting
    • Caio Araujo
    • Contact: Caio Araujo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional group; Early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care	Other: 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).; Trunk control.; Orthostatism.; Walk training.; Aerobic exercises.; Muscle strengthening.
No Intervention: Control group; Bed restriction strategy for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capacity 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.	5 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay.	Hospital Stay.	30 days.
Postoperative complications.	Incidence of postoperative complications using the Clavien-Dindo classification.	30 days.
Functional walking capacity, assessed by the 6-minute walk test.	Functional walking capacity, assessed by the 6-minute walk test.	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.	30 days.
Quality of life measured by the EuroQol-5D-5L Questionnaire.	Quality of life measured by the EuroQol-5D-5L Questionnaire.	30 days.
Incidence of deep venous thrombosis.	Incidence of deep venous thrombosis.	30 days.

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: NP1561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No