Correlation Between Physical Fitness Status and Quality of Postoperative Recovery in Gynaecological ERAS Patients

Completed

• Conditions: Gynecology; Postoperative Recovery; Enhanced Recovery After Surgery; Six-minute Walk Test; EQ5D5L-VAS

• Registration Number: NCT06704750
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

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

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six-minute walk test	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	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	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.

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences,Peking Union Medical College Hospital; 🇨🇳 Beijing, China