AnesthesiaNCT04519268
Adherence Degree of Kasr-Alaini Hospital Pre-anesthetic Tests to the NICE-UK Guidelines
An observational study of Anesthesia and Surgery, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
Routine preoperative tests aim to identify asymptomatic diseases that can't be recognized by history and examination. Identification and management of these diseases is thought to help minimizing perioperative morbidity and mortality. A large number of routine screening tests increase the cost of perioperative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgery, Exanimation
- What is being tested?
- Adult patients scheduled for an elective general surgical operation.
- How many people
- 185 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2020to 1 Feb 2021
- 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: Adult patients that will be scheduled for an elective surgical operation at Kasr Alaini hospital during the study period.
Who may be able to join
- All adult patients scheduled for elective surgical operations.
Who cannot join
- Patients operated upon an emergency basis.
- Pregnant females.
- Patients scheduled for cardio-thoracic and neurosurgical procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Degree of Adherence of Pre-anesthetic Tests at Kasr Alaini Hospital to the NICE-UK Guidelines, and Its Effect on Decision Making & Patient Outcome: Prospective Observational Study
Routine preoperative tests aim to identify asymptomatic diseases that can't be recognized by history and examination. Identification and management of these diseases is thought to help minimizing perioperative morbidity and mortality. A large number of routine screening tests increase the cost of perioperative care. Also unneeded tests may harm the patient due to overtreatment for borderline / false positive results. Therefore, the routine use of such examinations remains controversial.
The National Institute of Health and Clinical Excellence (NICE-UK) guidelines for preoperative examination are the assessment standard developed by NICE in collaboration with the National Collaboration Center for Acute Care in the UK; in order to reduce unnecessary tests by recommending which tests should be offered to people before minor and major operations.
The aim of this study is to assess the degree of adherence of the current preoperative tests at Kasr Alaini hospital to the NICE guidelines, to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in the hospital and to also evaluate the cause of delay \& its effect to predict postoperative complications.
- Conditions
- Anesthesia, Surgery, Exanimation
- Being tested
- Adult patients scheduled for an elective general surgical operation.
- Keywords
- Pre-anesthetic tests, NICE-UK guidlines, Kasr Alaini hospital
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult patients scheduled for an elective general surgical operation.Diagnostic test
The anesthesiologist, who is in charge of preoperative assessment at each hospital unit, will assess patients who are scheduled for elective surgery; and will inform senior anesthesiologists (with a minimum 3 years of experience) \& consultant anesthesiologists, about the patients' data.
Patients data with all requested preoperative investigations \& required preparations, peri-operative course and post-operative outcome will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Elective Surgical Adult Patients | Adult patients scheduled for an elective general surgical operation. Receives: Diagnostic Test: Adult patients scheduled for an elective general surgical operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Adherence to NICE-UK Guidelines
The degree of adherence of the current practices at Kasr Alaini hospital preoperative testing to the NICE-UK guidelines, determined as a "percentage".
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start20 Aug 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Beshoy A Naguib, MBBCh, Principal investigator, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityNazmy S Michael, MD, Study director, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityManar M Elkholy, MD, Study chair, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519268
- Sponsor's protocol ID
- ADPAT-KAH-NICEUKG
- Status last verified
- Mar 2021
- First submitted
- 17 Aug 2020
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Degree of Adherence of Pre-anesthetic Tests at Kasr Alaini Hospital to the NICE-UK Guidelines, and Its Effect on Decision Making & Patient Outcome: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04519268
- Acronym / sponsor ID
- ADPAT-KAH-NICEUKG
- Conditions
- Anesthesia, Surgery, Exanimation
- Keywords
- Pre-anesthetic tests, NICE-UK guidlines, Kasr Alaini hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 19 Aug 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.
Routine preoperative tests aim to identify asymptomatic diseases that can't be recognized by history and examination. Identification and management of these diseases is thought to help minimizing perioperative morbidity and mortality. A large number of routine screening tests increase the cost of perioperative care. Also unneeded tests may harm the patient due to overtreatment for borderline / false positive results. Therefore, the routine use of such examinations remains controversial.
The National Institute of Health and Clinical Excellence (NICE-UK) guidelines for preoperative examination are the assessment standard developed by NICE in collaboration with the National Collaboration Center for Acute Care in the UK; in order to reduce unnecessary tests by recommending which tests should be offered to people before minor and major operations.
The aim of this study is to assess the degree of adherence of the current preoperative tests at Kasr Alaini hospital to the NICE guidelines, to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in the hospital and to also evaluate the cause of delay \& its effect to predict postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Surgical Adult Patients | – | Diagnostic Test: Adult patients scheduled for an elective general surgical operation.Adult patients scheduled for an elective general surgical operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients that will be scheduled for an elective surgical operation at Kasr Alaini hospital during the study period.
Key inclusion criteria (1 listed)
- All adult patients scheduled for elective surgical operations.
Key exclusion criteria (3 listed)
- Patients operated upon an emergency basis.
- Pregnant females.
- Patients scheduled for cardio-thoracic and neurosurgical procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adult patients scheduled for an elective general surgical operation.The anesthesiologist, who is in charge of preoperative assessment at each hospital unit, will assess patients who are scheduled for elective surgery; and will inform senior anesthesiologists (with a minimum 3 years of experience) \& consultant anesthesiologists, about the patients' data. Patients data with all requested preoperative investigations \& required preparations, peri-operative course and post-operative outcome will be collected. | Diagnostic test | Elective Surgical Adult Patients |
Primary outcome
Degree of Adherence to NICE-UK Guidelines
Time frame: one week
The degree of adherence of the current practices at Kasr Alaini hospital preoperative testing to the NICE-UK guidelines, determined as a "percentage".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Beshoy A Naguib, MBBCh principal investigator
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Nazmy S Michael, MD study director
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Manar M Elkholy, MD study chair
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
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 Anesthesia and Surgery, run by Nazmy Edward Seif at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 Mar 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Adherence to NICE-UK Guidelines (time frame: one week). 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 16 Mar 2021.