NCT06456918

Brief Summary

The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

June 9, 2024

Last Update Submit

June 9, 2024

Conditions

Major Abdominal SurgeryPatient-reported Outcome

Keywords

major abdominal surgery, outcome, QoR-15, validation

Outcome Measures

Primary Outcomes (1)

  • To validate the QoR-15

    the survey was conducted on the day before the surgery (Pre), and on postoperative days 1 (P1), 7 (P7), and 30 (P30).

    September 2019-September 2022

Study Arms (1)

patients undergoing elective major gastrointestinal surgery

Patients had a planned elective major gastrointestinal surgery.

Procedure: Quality of Recovery 15 questionnaire

Interventions

Quality of Recovery 15 questionnairePROCEDURE

return to daily life after surgery according to the patient's baseline or social norms

patients undergoing elective major gastrointestinal surgery

Eligibility Criteria

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

510 patients who met the inclusion criteria of being over age of 18 and had a planned elective major gastrointestinal surgery were included in the study.

You may qualify if:

  • being over age of 18 and had a planned elective major gastrointestinal surgery

You may not qualify if:

  • under 18 years of age, had an alcohol or substance addiction problem, refused to participate in the study, had a previous major abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Ali Koc

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Study Officials

  • Mehmet A Koc, MD

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

September 1, 2019

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)