Correlation Between Physical Fitness Status and Quality of Postoperative Recovery in Gynaecological ERAS Patients
General Gynecology Center
1 other identifier
observational
146
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFirst Submitted
Initial submission to the registry
July 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 26, 2024
CompletedNovember 26, 2024
July 1, 2024
6 months
July 18, 2024
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Six-minute walk test
patients were instructed to walk back and forth in a marked 30-meter-long straight corridor as fast as they could tolerate.
since the preoperative period, followed up until the patients' walk test was fully restored to their follow-up preoperative levels,at most 1 month
EQ5D5L-VAS
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).
since the preoperative period, followed up until the patients' walk test was fully restored to their follow-up preoperative levels, at most 1 month
QoR-15
15-item Quality of Recovery Scale,the minimum value is 0 and maximum value is 150, and higher scores mean a better outcome.
on the preoperative period, on the 1 day of discharge
Interventions
patients were instructed to walk back and forth in a marked 30-meter-long straight corridor as fast as they could tolerate
Eligibility Criteria
A total of 146 patients were included in this study, and 114 patients completed full follow-up.The average age of the paticipants was 35.48 years old.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese Academy of Medical Sciences,Peking Union Medical College Hospital
Beijing, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2024
First Posted
November 26, 2024
Study Start
January 1, 2024
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
November 26, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share