QoR-15T-EL: Turkish Version of the QoR-15 for Emergency Laparotomy

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)

Overall Status

Recruiting

CT.gov ID

NCT05794269

Collaborator

(none)

100

Enrollment

Location

5.9

Anticipated Duration (Months)

16.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Anesthesia Surgery Postoperative Complications	Other: TQoR-15 questionnaire

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Validation of the Turkish Version of QoR-15 (QoR-15T) Scale for Emergency Laparotomy

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Validity of TQoR-15 questionnaire (24 hours) [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) [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)

Secondary Outcome Measures

Minimal important difference [At 24 and 72 hours after surgery]
Estimate minimal important difference from the TQoR-15 questionnaire in the emergency laparotomy population.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SBÜ Gülhane Education and Training Hospital	Etlik	Ankara	Turkey	06010

Sponsors and Collaborators

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Umut Kara, Associate Professor, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

ClinicalTrials.gov Identifier:

NCT05794269

Other Study ID Numbers:

2023-20

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 4, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Postoperative Complications

Study Results

No Results Posted as of Apr 4, 2023