Recovery of FunctionNCT04607577
Cross-cultural Adaptation and Validation in Moroccan Arabic Dialect "Darija" of the QoR-15 Postoperative Recovery Quality Score"
An observational study of Recovery of Function, run by Moroccan Society of Surgery at 1 site in Morocco.
Trial summary
The QoR-15 Is a post operative recovery score developed in 2013 from the QoR-40 with an advantage of simplification. The investigators Aim to translate and to validate a such useful score in Arabic adapted for Morocco by a full psychometric evaluation of the Arabic version, by testing its validity, reliability… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recovery of Function
- How many people
- 200 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Nov 2022to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All scheduled anesthesia procedures with a pre-anesthetic consultation, performed at INO, both in the digestive surgery operating room, as well as in gyneco-mammary and outpatient endoscopy, brachytherapy and conventional and interventional adult radiology
Who may be able to join
- Age ≥ 18 years
- Agreement in writing for the use of the data
Who cannot join
- Patients who expressed their refusal to participate in the study
- Patients unable to express their non-opposition to participating in the study
- Patients operated on for surgery for which it was highly probable that it would not be possible for them to answer the questionnaire postoperatively (first 24 hours)
- Patients who do not master the Arabic language, neither read nor spoken
Trial locations and contacts
1 site in 1 country.
About this study
The QoR-15 Is a post operative recovery score developed in 2013 from the QoR-40 with an advantage of simplification. The investigators Aim to translate and to validate a such useful score in Arabic adapted for Morocco by a full psychometric evaluation of the Arabic version, by testing its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, gynecological surgery, or digestive endoscopy in the National Institute of Oncology of Rabat, affiliated to Mohammed V University in Rabat, Morocco.
- Conditions
- Recovery of Function
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery 15 in Moroccan Arabic scale (QoR-15 MA) functional recovery score at recovery from anesthesia
Measured: One Hour after recovery from anesthesia
The differential between the QoR-15MA score preoperatively and postoperatively
Change from preoperative baseline of QoR-15MA to postoperative scale at one hour after recovery from anesthesia
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Nov 2022 (estimated)
- Primary completion22 Jan 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery of FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdelilah Ghannam, MD, Principal investigator, Mohammed V University in Rabat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607577
- Sponsor's protocol ID
- QoR-15MA
- Status last verified
- Aug 2022
- First submitted
- 20 Oct 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation in Moroccan Arabic Dialect "Darija" of the QoR-15 Postoperative Recovery Quality Score"
- ClinicalTrials.gov ID
- NCT04607577
- Acronym / sponsor ID
- QoR-15MA
- Conditions
- Recovery of Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 22 Jan 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The QoR-15 Is a post operative recovery score developed in 2013 from the QoR-40 with an advantage of simplification. The investigators Aim to translate and to validate a such useful score in Arabic adapted for Morocco by a full psychometric evaluation of the Arabic version, by testing its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, gynecological surgery, or digestive endoscopy in the National Institute of Oncology of Rabat, affiliated to Mohammed V University in Rabat, Morocco.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All scheduled anesthesia procedures with a pre-anesthetic consultation, performed at INO, both in the digestive surgery operating room, as well as in gyneco-mammary and outpatient endoscopy, brachytherapy and conventional and interventional adult radiology
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Agreement in writing for the use of the data
Key exclusion criteria (4 listed)
- Patients who expressed their refusal to participate in the study
- Patients unable to express their non-opposition to participating in the study
- Patients operated on for surgery for which it was highly probable that it would not be possible for them to answer the questionnaire postoperatively (first 24 hours)
- Patients who do not master the Arabic language, neither read nor spoken
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Quality of Recovery 15 in Moroccan Arabic scale (QoR-15 MA) functional recovery score at recovery from anesthesia
Time frame: One Hour after recovery from anesthesia
The differential between the QoR-15MA score preoperatively and postoperatively
Time frame: Day 1
Change from preoperative baseline of QoR-15MA to postoperative scale at one hour after recovery from anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Recovery of Function
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
RecruitingPhase 2
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Pain, Pituitary Surgery
Not yet recruiting
Physiology of Liberation
Psychophysiological Reactivity and Recovery
Recruiting
Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Immune Checkpoint Inhibitors Related Myocarditis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelilah Ghannam, MD principal investigator
Mohammed V University in Rabat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recovery of Function, run by Moroccan Society of Surgery at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelilah Ghannam, MD (+212661382585, abdelilah.ghannam@um5s.net.ma), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery 15 in Moroccan Arabic scale (QoR-15 MA) functional recovery score at recovery from anesthesia (time frame: One Hour after recovery from anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.