Quality of LifeQoR-15T-ELNCT05794269
Turkish Version of the QoR-15 for Emergency Laparotomy
An observational study of Quality of Life and Anesthesia, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery postoperatively. It provided an efficient evaluation of the postoperative quality of recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Anesthesia, Surgery
- What is being tested?
- TQoR-15 questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Aug 2023
- 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: All adult patients admitted for emergency laparotomy
Who may be able to join
- ≥ 18 years old,
- Turkish speaking,
- Admitted for any type of emergency laparotomy (time to surgery < 72 hours)
- Able to answer the questionnaire at hospital admission, alone or with the help of a third party
- And agreeing to participate in the study.
Who cannot join
- Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,
- Patients admitted for revision surgery,
- aged < 18 years old
- not agreed to provide written informed consent to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBÜ Gülhane Education and Training Hospital
Etlik, Ankara, 06010
Umut KARA, +905339392399, drumutkara@gmail.com
About this study
Official title: Validation of the Turkish Version of QoR-15 (QoR-15T) Scale for Emergency Laparotomy
Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery postoperatively. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is validate the Turkish version of QoR-15 questionnaire for emergency laparotomy. The investigators will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients emergency laparotomy, in the University of Health Sciences, Gülhane Education and Training Hospital Ankara, Türkiye.
Read the detailed description
Recovery from surgery is a complex process that can vary depending on the patient and the anesthesia used. Most clinical studies are interested in reducing perioperative morbidity and mortality, but few evaluate the overall recovery process. The QoR-15 questionnaire assess recovery after elective surgery. A Turkish translation of the QoR-15 score has been validated for use in scheduled surgery. This scale, regardless of the language in which it is translated, has been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency laparotomy.
- Conditions
- Quality of Life, Anesthesia, Surgery, Postoperative Complications
- Being tested
- TQoR-15 questionnaire
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQoR-15 questionnaireOther
The TQoR-15 questionnaire (Turkish version) consists of 15 questions concerning five domains (the patient's feelings, comfort, pain, dependence on the health care team and psychological well-being). Two to three minutes are required to complete all the questions. If the patient is not able to read the questionnaire himself, a third person can ask the patient the questions orally. Each item is scored from 0 to 10 and the total score is the sum of the score obtained for each item, i.e. a score from 0 to 150.
| Study group | Role | What they receive |
|---|---|---|
| Main Group | Each patient complete the Turkish version of the QoR-15 score (TQoR-15) at 3 times (before surgery, on Day 1, on Day 3). Receives: Other: TQoR-15 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of TQoR-15 questionnaire (24 hours)
Evaluate the validity of the Turkish version of the QoR-15 to assess immediate postoperative recovery after emergency laparotomy (at 24 hours)
Measured: At 24 hours after surgery
Validity of TQoR-15 questionnaire (72 hours)
Evaluate the validity of the Turkish version of the QoR-15 to assess immediate postoperative recovery after emergency laparotomy (at 72 hours)
Measured: At 72 hours after surgery
Secondary outcomes (1)
Minimal important difference
Estimate minimal important difference from the TQoR-15 questionnaire in the emergency laparotomy population.
Measured: At 24 and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Kara, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794269
- Sponsor's protocol ID
- 2023-20
- Acronym
- QoR-15T-EL
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
PubMed 36161615
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Turkish Version of QoR-15 (QoR-15T) Scale for Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT05794269
- Acronym / sponsor ID
- QoR-15T-EL / 2023-20
- Conditions
- Quality of Life, Anesthesia, Surgery, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 3 Apr 2023 (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.
Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery postoperatively. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is validate the Turkish version of QoR-15 questionnaire for emergency laparotomy. The investigators will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients emergency laparotomy, in the University of Health Sciences, Gülhane Education and Training Hospital Ankara, Türkiye.
Detailed description
Recovery from surgery is a complex process that can vary depending on the patient and the anesthesia used. Most clinical studies are interested in reducing perioperative morbidity and mortality, but few evaluate the overall recovery process. The QoR-15 questionnaire assess recovery after elective surgery. A Turkish translation of the QoR-15 score has been validated for use in scheduled surgery. This scale, regardless of the language in which it is translated, has been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency laparotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Group | – | Other: TQoR-15 questionnaireEach patient complete the Turkish version of the QoR-15 score (TQoR-15) at 3 times (before surgery, on Day 1, on Day 3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted for emergency laparotomy
Key inclusion criteria (5 listed)
- ≥ 18 years old,
- Turkish speaking,
- Admitted for any type of emergency laparotomy (time to surgery < 72 hours)
- Able to answer the questionnaire at hospital admission, alone or with the help of a third party
- And agreeing to participate in the study.
Key exclusion criteria (4 listed)
- Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,
- Patients admitted for revision surgery,
- aged < 18 years old
- not agreed to provide written informed consent to participate
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 |
|---|---|---|
| TQoR-15 questionnaireThe TQoR-15 questionnaire (Turkish version) consists of 15 questions concerning five domains (the patient's feelings, comfort, pain, dependence on the health care team and psychological well-being). Two to three minutes are required to complete all the questions. If the patient is not able to read the questionnaire himself, a third person can ask the patient the questions orally. Each item is scored from 0 to 10 and the total score is the sum of the score obtained for each item, i.e. a score from 0 to 150. | Other | Main Group |
Primary outcome
Validity of TQoR-15 questionnaire (24 hours)
Time frame: At 24 hours after surgery
Evaluate the validity of the Turkish version of the QoR-15 to assess immediate postoperative recovery after emergency laparotomy (at 24 hours)
Validity of TQoR-15 questionnaire (72 hours)
Time frame: At 72 hours after surgery
Evaluate the validity of the Turkish version of the QoR-15 to assess immediate postoperative recovery after emergency laparotomy (at 72 hours)
1 secondary outcome
Minimal important difference
Time frame: At 24 and 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Background: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Background: PubMed 36161615Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
- Individual participant dataSharing planned: Undecided
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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.
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 Quality of Life and Anesthesia, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umut KARA (+905339392399, drumutkara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of TQoR-15 questionnaire (24 hours) (time frame: At 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05794269, which also lists 2 linked publications.
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 4 Apr 2023.