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NCT Number: NCT06704750

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

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.

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Key information

Conditions

Gynecology EQ5D5L-VAS Enhanced Recovery After Surgery Postoperative Recovery Six-minute Walk Test

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Chinese Academy of Medical Sciences,Peking Union Medical College Hospital

Beijing, China

About this study

  • Investigate the current status of perioperative physical fitness and postoperative recovery quality of gynaecological ERAS patients
  • Explore the correlation between the physical fitness status of gynaecological ERAS patients and the quality of postoperative recovery.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

6-Minute Walk Test

Behavioral

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

Other names: EQ5D5L questionnaire, QOR-15 questiannaire

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

General Gynecology Center

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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