Turkish Version of the QoR-15 for Emergency Laparotomy

Recruiting

• Conditions: Quality of Life; Surgery; Postoperative Complications; Anesthesia
• Interventions: Other: TQoR-15 questionnaire

• Registration Number: NCT05794269
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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.

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-31
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-04
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main Group	TQoR-15 questionnaire	Each patient complete the Turkish version of the QoR-15 score (TQoR-15) at 3 times (before surgery, on Day 1, on Day 3).

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

SBÜ Gülhane Education and Training Hospital; 🇹🇷 Etlik, Ankara, Turkey