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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Capacity of functional walking.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Capacity of functional walking.
时间窗: 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.
次要结局
- Incidence of deep venous thrombosis.(30 days.)
- Hospital stay.(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.)
- Postoperative complications.(30 days.)