NCT06704750

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 18, 2024

Last Update Submit

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

Also known as: EQ5D5L questionnaire, QOR-15 questiannaire

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Locations