GynecologyNCT06704750
Correlation Between Physical Fitness Status and Quality of Postoperative Recovery in Gynaecological ERAS Patients
An observational study of Gynecology and Postoperative Recovery, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gynecology, Postoperative Recovery, Enhanced Recovery After Surgery
- What is being tested?
- 6-minute walk test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences,Peking Union Medical College Hospital
Beijing
About this study
Official title: 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.
Read the detailed description
- 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
- Conditions
- Gynecology, Postoperative Recovery, Enhanced Recovery After Surgery, Six-minute Walk Test, EQ5D5L-VAS
- Being tested
- 6-minute walk test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testBehavioural
Also called EQ5D5L questionnaire, QOR-15 questiannaire
patients were instructed to walk back and forth in a marked 30-meter-long straight corridor as fast as they could tolerate
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: on the preoperative period, on the 1 day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecologyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704750
- Sponsor's protocol ID
- K5257
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Gynecology Center
- ClinicalTrials.gov ID
- NCT06704750
- Acronym / sponsor ID
- K5257
- Conditions
- Gynecology, Postoperative Recovery, Enhanced Recovery After Surgery, Six-minute Walk Test, EQ5D5L-VAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk testAlso: EQ5D5L questionnaire, QOR-15 questiannairepatients were instructed to walk back and forth in a marked 30-meter-long straight corridor as fast as they could tolerate | Behavioural | – |
Primary outcome
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecology and Postoperative Recovery, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.