跳至主要内容
临床试验/CTRI/2025/09/094417
CTRI/2025/09/094417尚未招募不适用

Correlation between Postoperative Quality of Recovery and three-month Quality of Life, and Utility of the QoR-15 questionnaire following Gynaecological Cancer Surgery

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月20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
100
试验地点
1
主要终点
correlation between QoR-15H with the Quality of life using SF-12

研究概览

简要总结

For each patient, the Hindi version of QoR-15 i.e. QoR-15H will be filled at baseline i.e. in the preoperative room and then again after surgery at the end of day 1, day 3 and day 7.  Higher scores indicate a better quality of recovery. For objective measure of postoperative global recovery, patient-perceived Global Recovery Score (0 -no recovery; 100-Best possible recovery) and NRS-Pain (0 being no pain to 10 being worst possible pain) assessment will be recorded at the end of postoperative day 1, 3 and 7. The primary outcome of the study is to determine correlation between QoR-15H scores at day 1, 3 and 7 with the Quality of life using SF-12 at three months. The secondary outcomes will be to determine correlation between various domains QoR-15H scores at day 1, 3 and 7 with the related domains of EORTC QLQ-C30 at three months; the association between QoR-15H scores with ICU stay, postoperative complications and mortality at three months. In addition, the psychometric analysis of QoR-15H in gynaecological cancer surgeries will also be done.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • ASA PS II or III undergoing cancer surgery under GA and epidural block, who can read and write Hindi and are available for three-months follow up either in person or telephonically.

排除标准

  • Patients will be excluded if had cognitive dysfunction, alcohol or drug dependence, severe preexisting medical condition, emergency surgery or life-threatening postoperative complication.

结局指标

主要结局

correlation between QoR-15H with the Quality of life using SF-12

时间窗: correlation between QoR-15H with the Quality of life using SF-12

次要结局

  • Correlation between various domains QoR-15H scores with the related domains of EORTC QLQ-C30; the association between QoR-15H scores with ICU stay, postoperative complications & mortality; psychometric analysis of QoR-15H in cancer surgeries.(Correlation between various domains QoR-15H scores at day 1, 3 & 7 with the related domains of EORTC QLQ-C30 at three months; the association between QoR-15H scores with ICU stay, postoperative complications & mortality at three months; psychometric analysis of QoR-15H in cancer surgeries.)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Geetanjali T Chilkoti

UCMS and GTB hospital

研究点 (1)

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