Major Abdominal SurgeryValidQoR-15NCT06456918
ValidationTurkishVersionQualityofRecovery-15
An observational study of Major Abdominal Surgery and Patient-reported Outcome, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery, Patient-reported Outcome
- What is being tested?
- Quality of Recovery 15 questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 510 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 510 patients who met the inclusion criteria of being over age of 18 and had a planned elective major gastrointestinal surgery were included in the study.
Who may be able to join
- being over age of 18 and had a planned elective major gastrointestinal surgery
Who cannot join
- under 18 years of age, had an alcohol or substance addiction problem, refused to participate in the study, had a previous major abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Turkish Version of the "Quality of Recovery 15 (QoR-15)" Questionnaire
The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.
Read the detailed description
The QoR-15 was translated into Turkish through a rigorous process involving independent translations, consensus, back-translation, and review. The questionnaire was administered to patients undergoing elective major gastrointestinal surgery preoperatively and on postoperative days 1, 7, and 30. Reliability was assessed using Cronbach's α and intra-class correlation coefficient. Construct validity was evaluated through confirmatory factor analysis, and responsiveness was analyzed using Cohen's effect size and standardized response mean.
- Conditions
- Major Abdominal Surgery, Patient-reported Outcome
- Being tested
- Quality of Recovery 15 questionnaire
- Keywords
- major abdominal surgery, outcome, QoR-15, validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Recovery 15 questionnaireProcedure or surgery
return to daily life after surgery according to the patient's baseline or social norms
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing elective major gastrointestinal surgery | Patients had a planned elective major gastrointestinal surgery. Receives: Procedure: Quality of Recovery 15 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the QoR-15
the survey was conducted on the day before the surgery (Pre), and on postoperative days 1 (P1), 7 (P7), and 30 (P30).
Measured: September 2019-September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Sep 2019
- Primary completion1 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Koç, Ankara University
- Investigators
- Mehmet A Koc, MD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456918
- Sponsor's protocol ID
- U1111-1309-0952
- Acronym
- ValidQoR-15
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Turkish Version of the "Quality of Recovery 15 (QoR-15)" Questionnaire
- ClinicalTrials.gov ID
- NCT06456918
- Acronym / sponsor ID
- ValidQoR-15 / U1111-1309-0952
- Conditions
- Major Abdominal Surgery, Patient-reported Outcome
- Keywords
- major abdominal surgery, outcome, QoR-15, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Jun 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.
The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.
Detailed description
The QoR-15 was translated into Turkish through a rigorous process involving independent translations, consensus, back-translation, and review. The questionnaire was administered to patients undergoing elective major gastrointestinal surgery preoperatively and on postoperative days 1, 7, and 30. Reliability was assessed using Cronbach's α and intra-class correlation coefficient. Construct validity was evaluated through confirmatory factor analysis, and responsiveness was analyzed using Cohen's effect size and standardized response mean.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing elective major gastrointestinal surgery | – | Procedure: Quality of Recovery 15 questionnairePatients had a planned elective major gastrointestinal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 510 patients who met the inclusion criteria of being over age of 18 and had a planned elective major gastrointestinal surgery were included in the study.
Key inclusion criteria (1 listed)
- being over age of 18 and had a planned elective major gastrointestinal surgery
Key exclusion criteria (1 listed)
- under 18 years of age, had an alcohol or substance addiction problem, refused to participate in the study, had a previous major abdominal surgery
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 |
|---|---|---|
| Quality of Recovery 15 questionnairereturn to daily life after surgery according to the patient's baseline or social norms | Procedure or surgery | patients undergoing elective major gastrointestinal surgery |
Primary outcome
To validate the QoR-15
Time frame: September 2019-September 2022
the survey was conducted on the day before the surgery (Pre), and on postoperative days 1 (P1), 7 (P7), and 30 (P30).
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 13 Jun 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.
Mehmet A Koc, MD principal investigator
Ankara University
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 Major Abdominal Surgery and Patient-reported Outcome, run by Ankara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 13 Jun 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 Turkey (Türkiye). 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?
To validate the QoR-15 (time frame: September 2019-September 2022). 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 13 Jun 2024.