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 | Unknown DMC

• 1 other identifier: NP1561
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Hospital stay.

  30 days.

• Postoperative complications.

  30 days.

• Functional walking capacity, assessed by the 6-minute walk test.

  30 days.

• Incidence and intensity of fatigue measured by the Piper Revised Fatigue Scale.

  30 days.

• Quality of life measured by the EuroQol-5D-5L Questionnaire.

  30 days.

Study Arms (2)

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

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.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Caio Araujo

São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Caio Araujo, MD

CONTACT

+5511973692436; caio.araujo@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: March 9, 2020
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)