Rectal CancerNCT04795609

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.

A study testing Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group). in people with Rectal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rectal Cancer
What is being tested?: Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteBrazil
Study dates: 9 Mar 2020to 1 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Caio Araujo, MD contact

+5511973692436

caio.araujo@hc.fm.usp.br

Brazil1 site, 1 recruiting

Caio Araujo
São Paulo, 01246-000
Caio Araujo, MD
Recruiting

Other trials in Brazil

About this study

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.

Conditions: Rectal Cancer
Being tested: Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).
1. Trunk control.
2. Orthostatism.
3. Walk training.
4. Aerobic exercises.
5. Muscle strengthening.

Study groups in NCT04795609
Study group	Role	What they receive
Interventional group	Active comparator	Early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 days.

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20201 Jul 2022

First posted12 Mar 2021
Study start9 Mar 2020
Primary completion31 Dec 2021 (estimated)
Study completion1 Jul 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04795609
Sponsor's protocol ID: NP1561
Status last verified: Mar 2021
First submitted: 10 Mar 2021
Last updated: 12 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Caio Araujo, MD

+5511973692436

caio.araujo@hc.fm.usp.br

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04795609
Acronym / sponsor ID: NP1561
Conditions: Rectal Cancer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 32 participants (estimated)
Lead sponsor: Instituto do Cancer do Estado de São PauloUniversity, hospital or other
Study start: 9 Mar 2020 (actual)
Primary completion: 31 Dec 2021 (estimated)
Study completion: 1 Jul 2022 (estimated)
First posted: 12 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Interventional group	Active comparator	Other: Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).Early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care
Control group	No intervention	–Bed restriction strategy for 5 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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). 1. Trunk control. 2. Orthostatism. 3. Walk training. 4. Aerobic exercises. 5. Muscle strengthening.	Other	Interventional group

Primary outcome

Capacity of functional walking.
Time frame: 5 days.
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.

6 secondary outcomes

Hospital stay.
Time frame: 30 days.
Postoperative complications.
Time frame: 30 days.
Functional walking capacity, assessed by the 6-minute walk test.
Time frame: 30 days.
Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.
Time frame: 30 days.
Quality of life measured by the EuroQol-5D-5L Questionnaire.
Time frame: 30 days.
Incidence of deep venous thrombosis.
Time frame: 30 days.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Caio Araujo, MD contact

+5511973692436

caio.araujo@hc.fm.usp.br

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Caio Araujo, MD (+5511973692436, caio.araujo@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Capacity of functional walking. (time frame: 5 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04795609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.