NCT05794269

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 20, 2023

Last Update Submit

March 31, 2023

Conditions

Quality of LifeAnesthesiaSurgeryPostoperative Complications

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    At 72 hours after surgery

Secondary Outcomes (1)

  • Minimal important difference

    At 24 and 72 hours after surgery

Study Arms (1)

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).

Other: TQoR-15 questionnaire

Interventions

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.

Main Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients admitted for emergency laparotomy

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Gülhane Education and Training Hospital

Etlik, Ankara, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23411725BACKGROUND

  • 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.

    PMID: 36161615BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Umut KARA

CONTACT

+905339392399drumutkara@gmail.com

Serkan ŞENKAL

CONTACT

+905338142614senkalserkan@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 3, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

TU(1)