Evaluation of perioperative outcomes with enhanced recovery after surgery alone versus combined enhanced recovery after surgery and prehabilitation in patients undergoing surgery for advanced ovarian cancer:- An open labelled randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Functional capacity assessment using cardiopulmonary testing by six minute
研究概览
简要总结
Aim
To compare the efficacy of a robust prehabilitation program in combination with
enhanced recovery after surgery (ERAS) on functional parameters and perioperative
outcomes versus enhanced recovery after surgery (ERAS) alone in women
undergoing surgery for advanced ovarian cancer
Objectives
Primary objective
a) To compare cardiopulmonary function, nutritional parameters and
psychological status before and after implementation of prehabilitation
program with enhanced recovery after surgery (ERAS) versus enhanced
recovery after surgery (ERAS) alone
b) To assess and compare perioperative outcomes in both groups
Secondary objectives
a) Adherence to prehabilitation program
b) To study adverse events related to prehabilitation
Hypothesis
Addition of prehabilitation to enhanced recovery after surgery (ERAS) will improve
perioperative outcomes in women undergoing surgery for advanced ovarian cancer.
Methodology
All patients presenting with advanced ovarian cancer presenting to our institution
after informed consent and meeting inclusion criteria will be included in the study. All
eligible patients planned for primary upfront or interval debulking surgery after
chemotherapy for advanced ovarian cancer will be recruited to the study. For upfront
surgery patients will be hospitalised for work-up and optimisation of general condition
which will take around 3 weeks and interventions will be administered under direct
supervision .Patients receiving neoadjuvant chemotherapy will take around 3
months .Initial hospitalisation will be done for work up and treatment planning. During
this period they will be taught prehabilitation measures. Thereafter this will be
recorded in a chart (Annexure 1). Randomization will be done using simple random
number table to intervention and control groups (group 1 & 2) in a 1:1 ratio.
Allocation to each group will be done using block randomisation in which A group will
represent patients undergoing ERAS and prehabilitation and B group will represent
patients undergoing only for ERAS. The intervention group will have ERAS plus
prehabilitation while control group will undergo ERAS as part of standard
preoperative protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Advanced ovarian cancer for upfront surgery or after NACT
- •Preoperative schedule that allows from at least 3 weeks for upfront surgery and upto three months for interval debulking surgery
- •Treatment naive patients
- •Eastern Cooperative Oncology Group Performance Status of up to 2.
排除标准
- •Significant comorbidities or limitation of locomotion that prohibit the patient to perform prehabilitation activities
- •Emergency surgeries
- •Surgeries by minimally invasive approach (laparoscopy or robotics)
- •Patients suffering from depression and major psychiatric illness.
结局指标
主要结局
1. Functional capacity assessment using cardiopulmonary testing by six minute
时间窗: 3 weeks to 3 months
walk test (6 MWT) and pulmonary function tests using spirometry.
时间窗: 3 weeks to 3 months
2. Nutritional assessment by serum albumin levels, body mass index, and hand
时间窗: 3 weeks to 3 months
grip strength test
时间窗: 3 weeks to 3 months
3. Quality of life assessment using European Organization for Research and
时间窗: 3 weeks to 3 months
Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-
时间窗: 3 weeks to 3 months
C30)
时间窗: 3 weeks to 3 months
4. To measure intraoperative anaesthetic parameters - peak pressure, plateau
时间窗: 3 weeks to 3 months
pressure, lactate levels, tidal volume, temperature, urine output, ionotropic
时间窗: 3 weeks to 3 months
requirement, cardiac ejection fraction, problems during weaning off
时间窗: 3 weeks to 3 months
(extubation failure and immediate need for re-intubation and post extubation
时间窗: 3 weeks to 3 months
stridor)
时间窗: 3 weeks to 3 months
5. To measure intraoperative surgical outcomes - duration of surgery in minutes ,
时间窗: 3 weeks to 3 months
blood loss, transfusion of blood and blood products, cytoreductive outcomes,
时间窗: 3 weeks to 3 months
surgical complexity score.
时间窗: 3 weeks to 3 months
次要结局
- 1. Proportion of patients with adherence to prehabilitation program as measured(by asking them to maintain and enter daily records of exercises, diet and)
研究者
Pooja
All India Institute of Medical Sciences, Rishikesh