Effect of a Post-operative Protocol of Early Mobilization... | NCT04795609

Studies
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.

NCT04795609

Sponsor

Instituto do Cancer do Estado de São Paulo

Status

Unknown status

Last Update Posted

Mar 12, 2021Actual

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

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

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

Mar 10, 2021

First Submission Date that Met QC Criteria

Mar 10, 2021

First Posted Date

Mar 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2021

Last Update Posted Date

Mar 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional group	Active Comparator	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).
Control group	No Intervention	Bed restriction strategy for 5 days

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).	Other	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.

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Hospital stay.	Hospital Stay.	30 days.
Postoperative complications.	Incidence of postoperative complications using the Clavien-Dindo classification.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caio Araujo, MD	Contact	+5511973692436		caio.araujo@hc.fm.usp.br

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caio Araujo	Recruiting	São Paulo		01246-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D000099090	Surgical Procedures, Colorectal
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative