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

November 25, 2024 updated by: Peking Union Medical College Hospital

General Gynecology Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese Academy of Medical Sciences，Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-minute walk test
Time Frame: 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.
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
Time Frame: 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).
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
Time Frame: 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.
on the preoperative period, on the 1 day of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • K5257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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