Clinical trial NCT05794269: Turkish Version of the QoR-15 for Emergency Laparotomy
Official title: Validation of the Turkish Version of QoR-15 (QoR-15T) Scale for Emergency Laparotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Anesthesia
Surgery
Postoperative Complications
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted for emergency laparotomy

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Validity of TQoR-15 questionnaire (24 hours)
timeFrame: At 24 hours after surgery
measure: Validity of TQoR-15 questionnaire (72 hours)
timeFrame: At 72 hours after surgery
Secondary outcomes:
measure: Minimal important difference
timeFrame: At 24 and 72 hours after surgery
Other outcomes:
Locations:
city: Etlik
country: Turkey
facility: SBÜ Gülhane Education and Training Hospital
state: Ankara
Study officials:
References:
citation: 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.
citation: Kara 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.