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临床试验/CTRI/2025/08/092566
CTRI/2025/08/092566尚未招募不适用

Comparison of postoperative quality of recovery between laparoscopic cholecystectomy and robotic cholecystectomy done under general anaesthesia in adults - an observational study

Naidile R1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the quality of recovery in patients undergoing laparoscopic cholecystectomy and robotic cholecystectomy under general anesthesia in a single tertiary-level centre

研究概览

简要总结

This is an observational study comparing the quality of recovery between patients undergoing laparoscopic cholecystectomy or robotic cholecystectomy under general anaesthesia and to assess the correlation between age gender duration of surgery and anaesthesia with QOR 15. Baseline score is calculated from the QOR 15 scale consisting of positive and negative symptoms pre-operatively.  The same scale is given to the patients postoperatively on day 0 and Day 1 and the scores are calculated. Scores above 135 out of 150 indicate a good quality of recovery.The health status or quality of life of patients after surgery and anaesthesia has become an important endpoint in clinical studies as it influences the outcome of care. The quality of recovery of patients post-surgery is indicative of a successful perioperative experience. The quality of post operative recovery is an essential end point for evaluating anaesthesia and surgical measure. Patient reported outcomes and satisfaction in addition to psychological indicators of recovery help us assess the effects of anaesthesia and surgery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1 and ASA grade 2 patients.

排除标准

  • Patient Refusal Hemodynamically unstable patients Patients with low GCS Emergency procedures Patients unable to understand the components of questionnaire.

结局指标

主要结局

To compare the quality of recovery in patients undergoing laparoscopic cholecystectomy and robotic cholecystectomy under general anesthesia in a single tertiary-level centre

时间窗: A questionnaire will be given to patients before to the surgery part A, consisting of 10 questions on a likert scale based on patients positive symptoms and part B has 5 questions consisting patients negative symptoms each symptom can be scored 1-10 the score prior to surgery is the base line score patient is asked to answer the same questionnaire within 1 hour post surgery and 24 hours post surgery, to compare quality of recovery

次要结局

  • To assess the correlation between age gender duration of surgery and anaesthesia with QOR-15 score(Scores will be recorded preoperatively and within 1 hour postoperatively and 24 hours postoperatively and quality of recovery will be comapred)

研究者

发起方
Naidile R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Naidile R

St.Johns Medical College Hospital

研究点 (1)

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