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.
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Caio AraujoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Interventional group
Control group
Arm Description
Early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care
Bed restriction strategy for 5 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hospital stay.
Hospital Stay.
Postoperative complications.
Incidence of postoperative complications using the Clavien-Dindo classification.
Functional walking capacity, assessed by the 6-minute walk test.
Functional walking capacity, assessed by the 6-minute walk test.
Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
Quality of life measured by the EuroQol-5D-5L Questionnaire.
Quality of life measured by the EuroQol-5D-5L Questionnaire.
Incidence of deep venous thrombosis.
Incidence of deep venous thrombosis.
Full Information
NCT ID
NCT04795609
First Posted
March 10, 2021
Last Updated
March 10, 2021
Sponsor
Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04795609
Brief 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.
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Active Comparator
Arm Description
Early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Bed restriction strategy for 5 days
Intervention Type
Other
Intervention Name(s)
Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Capacity of functional walking.
Description
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.
Secondary Outcome Measure Information:
Title
Hospital stay.
Description
Hospital Stay.
Time Frame
30 days.
Title
Postoperative complications.
Description
Incidence of postoperative complications using the Clavien-Dindo classification.
Time Frame
30 days.
Title
Functional walking capacity, assessed by the 6-minute walk test.
Description
Functional walking capacity, assessed by the 6-minute walk test.
Time Frame
30 days.
Title
Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
Description
Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
Time Frame
30 days.
Title
Quality of life measured by the EuroQol-5D-5L Questionnaire.
Description
Quality of life measured by the EuroQol-5D-5L Questionnaire.
Time Frame
30 days.
Title
Incidence of deep venous thrombosis.
Description
Incidence of deep venous thrombosis.
Time Frame
30 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caio Araujo, MD
Phone
+5511973692436
Email
caio.araujo@hc.fm.usp.br
Facility Information:
Facility Name
Caio Araujo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caio Araujo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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