跳至主要内容
临床试验/NCT06704750
NCT06704750已完成不适用

General Gynecology Center

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
1
主要终点
Six-minute walk test

研究概览

简要总结

Investigate the current status of perioperative physical fitness.To compare the degree of agreement between the 6-minute walk test and the EQ5D5L-VAS score in assessing recovery after gynecological ERAS, and to provide a reference for a more scientific and comprehensive assessment of patients' physical recovery after gynecological ERAS.

详细描述

  1. Investigate the current status of perioperative physical fitness and postoperative recovery quality of gynaecological ERAS patients
  2. Explore the correlation between the physical fitness status of gynaecological ERAS patients and the quality of postoperative recovery.
  3. Based on the correlation between patients' physical fitness status and the quality of postoperative recovery, to further determine the optimal threshold of the 6MWT distance

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 18-50 years old;
  • diagnosed with benign gynecological diseases and undergoing laparoscopic surgery;
  • acceptance of ERAS modality;
  • normal cognitive communication ability and proficiency in the use of smartphones;
  • without motor disabilities.

排除标准

  • unstable angina and myocardial infarction within 1 month;
  • heart rate >120 beats/minute at rest, systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg;
  • diagnosis of anxiety and depression;
  • pregnancy.

结局指标

主要结局

Six-minute walk test

时间窗: since the preoperative period, followed up until the patients' walk test was fully restored to their follow-up preoperative levels,at most 1 month

patients were instructed to walk back and forth in a marked 30-meter-long straight corridor as fast as they could tolerate.

EQ5D5L-VAS

时间窗: since the preoperative period, followed up until the patients' walk test was fully restored to their follow-up preoperative levels, at most 1 month

5-level EQ-5D version,The first part is a descriptive system, assessing health in five dimensions.The second part of the questionnaire consists of a visual analog scale (VAS) on which patients mark their perceived level of health on a scale ranging from 0 (worst conceivable state of health) to 100 (best conceivable state of health).

QoR-15

时间窗: on the preoperative period, on the 1 day of discharge

15-item Quality of Recovery Scale,the minimum value is 0 and maximum value is 150, and higher scores mean a better outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验