Efficacy of Multimodal Prehabilitation of Liver Donors in enhancing Post Operative Recovery - A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To compare the peak ALT (Alanine Aminotransferase) between the two groups.
研究概览
简要总结
All individuals being worked up under the Department of Gastrointestinal Surgery and Multi-Visceral Organ Transplantation for Donor Hepatectomy will be recruited in the study after obtaining written informed consent.
Demographic details (Patient’s Name, Age, Phone number and Gender), and Anthropometric parameter (Height, Weight, BMI, Waist circumference) are recorded.
Patient comorbidities (diabetes, hypertension, dyslipidaemia and hypothyroidism) are documented.
Donors are randomly assigned to 2 groups using computer generated randomization to a study and a control arm by the randomization protocol explained above. Patients in the study arm are subjected to a minimum of 2 weeks of prehabilitation which include: - Tailored Monitored High Intensity Interval Training (HIIT) exercise, A high protein, low fat diet with total calorie intake equalling the basal requirement and education and encouragement to practice Inspiratory muscle training (IMT) and Incentive Spirometry (IS).
Baseline laboratory investigations include, CBC, LFT, RFT, Lipid profile, PT - INR, S.E and Liver regeneration markers.
Intra operatively, Wedge liver biopsy is taken in all the Graft livers during bench preparation. Following the Donor Hepatectomy, the donors are observed in the ICU for 3/4 days and later shifted to the ward. Routine labs including LFT and PT-INR are done daily, and they are usually discharged by day 6/7 in case of an uneventful post-op period.
Follow up is done after 14-21 days with routine labs and Plain CT to check for liver regeneration volumetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Voluntary healthy donors, between the age group of 18 to 60 years, having a body mass index (BMI) between 18 and 30 kg/m2, emotionally related to the patient, medically fit, and without any psychiatric illness, after being evaluated in a stepwise manner and deemed fit for donor hepatectomy through our institution’s protocol.
排除标准
- •Donors undergoing liver donation for emergency Liver Transplant are Excluded Donors with fatty liver with LAI 9Liver Spleen Attenuation index) Less than (-9) at any point during their donor workup.
结局指标
主要结局
To compare the peak ALT (Alanine Aminotransferase) between the two groups.
时间窗: 1 to 2 weeks
次要结局
- Time of Normalization of Serum Bilirubin and PT-INR between the two groups.(1 to 2 weeks)
- Peak AST (Aspartate Aminotransferases), PT-INR(Prothrombin Time - International Normalized ratio) , Serum Bilirubin between the two groups.(1 to 2 weeks)
- Liver volume regeneration between the two groups(2 to 3 weeks)
- Intraoperative liver biopsy (steatosis) between the two groups.(At surgery)
- Liver-regeneration markers between the two groups(At Donor workup and at post op day 3)
- Blood loss , Hospital stay , Complication rate post surgery (Clavien Dindo Classification)(1 to 2 weeks)
- Rates of early graft dysfunction in recipients (Olthoff criteria)(1 to 2 weeks)
研究者
Dr Vinaya Chandra C
Amrita Institute Of Medical Science
