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.

Rectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795609
• Other study ID #: NP1561
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2021
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Caio Araujo, MD
• Phone: +5511973692436
• Email: caio.araujo[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications
• Rectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Brazil	Caio Araujo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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