Preoperative Anaesthesia ClinicNCT05520229
The Evaluation of a Preanaesthesia Assessment Clinic
An observational study of Preoperative Anaesthesia Clinic and Cancellation Rate, run by University of Agder.
Trial summary
International evidence highlights the preanaesthetic assessment clinics (PAC) as a system of benefits for both the patient and the anaesthesiologist. The system has gained global acceptance as a routine method of optimising patients' medical conditions prior to surgery and therefore minimising surgery cancellations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anaesthesia Clinic, Cancellation Rate, Intraoperative Events
- How many people
- 2,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 3 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients who have been to surgery for open or laparoscopic partial excision of the intestine.
Who may be able to join
- Patients over 18 years old.
- Open or laparoscopic surgery on elective patients after partial excision of the intestine.
- Patients following the ERAS (Enhanced recovery after surgery) protocol after the year 2014.
- Patients who attended PAC after the year 2017 and were assessed by anesthesia staff.
Who cannot join
- Emergency patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Evaluation of a Preoperative Anaesthesia Assessment Clinic on Elective Patients After Partial Excision of the Intestine
International evidence highlights the preanaesthetic assessment clinics (PAC) as a system of benefits for both the patient and the anaesthesiologist. The system has gained global acceptance as a routine method of optimising patients' medical conditions prior to surgery and therefore minimising surgery cancellations and improving hospital efficiency. However, a systematic review found no evidence of the efficiency of (PAC) and therefore we wanted to investigate this with the use of hospitals journals.
Read the detailed description
The aim of this study is to evaluate the incidence, causes, and consequences of cancellations, and unanticipated intraoperative events after open or laparoscopic surgery of hemicolectomy patients before and after the implementation of a preoperative anaesthesia assessment clinic (PAC).
The primary outcome is to evaluate the incidence of cancellations and unanticipated intraoperative events after open or laparoscopic surgery of hemicolectomy patients before and after implementation of the preoperative anaesthesia assessment clinic (PAC).
The secondary outcome is to evaluate the patients' characteristics, the main events leading to cancellations and the consequences this brings to the patient and the hospital.
Adverse events reported pre-and post-intervention will be analysed. Patient characteristics will be collected: age, gender, diagnosis, reason and type of surgery, patient admission, assessed in PAC or not, ASA classification (American Society of Anesthesiologist Classification system), who performed the assessment (anaesthetic nurse or anaesthesiologist), type of anaesthesia, former diagnosis/disease with impact on anaesthesia/surgery, present smoker, allergies, blood samples, other examinations, cancellation of surgery, reasons and consequences for cancellations, time of anaesthetic assessment before surgery, intraoperative events, mallampati, Intubation grade, BMI and type of medication.
A specific data collection form will be developed and the data will be collected retrospectively from patient journals.
The number is calculated to: n = 588, n = 294 before and after the implementation of PAC. We use a significance level of 5%. To achieve statistical strength of 80% (beta = 20%), we need 288 patients before and after PAC to detect a difference of at least 10%. Given that we have the opportunity to include many more then we assume that our study has adequate strength. Prevalences of cancellations are estimated as shares and presented with 95% confidence intervals (CIs) calculated using the exact method. Possible differences in background variables in patients included before and after the implementation of PAC will be estimated using kji-square tests or t-tests. The effect of the implementation of PAC will be estimated using logistic regression adjusted for possible confounding factors and results will be presented as adjusted odds ratio (OR) with 95% CI.
- Keywords
- Anesthesia, cancellation, pre-operative, clinic, assessment
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre- Preanaesthesia assessment clinic | Patients who have been to surgery for an elective laparoscopic or open partial intestine from 2014-2017. | |
| Post- Preanaesthesia assessment clinic | Patients who have been to surgery for an elective laparoscopic or open partial intestine from 2017 and have attended a preanesthesia clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancellation rate, Intraoperative events
Incidence of Cancellation rate and unanticipated intraoperative events
Measured: 2014-2022
Secondary outcomes (1)
Patient's characteristics , cancellation main events and concequenses.
Patients'characteristics, main events leading to cancellations of surgery, consequenses the cancellations brings to patients and the hospital.
Measured: 2014-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Dec 2022 (estimated)
- Primary completion3 Feb 2023 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative Anaesthesia ClinicStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Agder
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Responsible party
- Principal investigator, Eirunn Wallevik Kristoffersen, University of Agder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520229
- Sponsor's protocol ID
- Eirunn W. Kristoffersen
- Status last verified
- Nov 2022
- First submitted
- 25 Aug 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Kristoffersen EW, Fossum M, Tveit TO, Berge GT, Hagen MC, Opsal A. Comparison of elective hemicolectomy patients before and after establishment of a preoperative anaesthesia assessment clinic: a retrospective, observational study in a hospital in Norway. BMJ Open. 2025 Jun 12;15(6):e100922. doi: 10.1136/bmjopen-2025-100922.
PubMed 40506071
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Preoperative Anaesthesia Assessment Clinic on Elective Patients After Partial Excision of the Intestine
- ClinicalTrials.gov ID
- NCT05520229
- Acronym / sponsor ID
- Eirunn W. Kristoffersen
- Keywords
- Anesthesia, cancellation, pre-operative, clinic, assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- University of AgderUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 3 Feb 2023 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 29 Aug 2022 (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.
International evidence highlights the preanaesthetic assessment clinics (PAC) as a system of benefits for both the patient and the anaesthesiologist. The system has gained global acceptance as a routine method of optimising patients' medical conditions prior to surgery and therefore minimising surgery cancellations and improving hospital efficiency. However, a systematic review found no evidence of the efficiency of (PAC) and therefore we wanted to investigate this with the use of hospitals journals.
Detailed description
The aim of this study is to evaluate the incidence, causes, and consequences of cancellations, and unanticipated intraoperative events after open or laparoscopic surgery of hemicolectomy patients before and after the implementation of a preoperative anaesthesia assessment clinic (PAC).
The primary outcome is to evaluate the incidence of cancellations and unanticipated intraoperative events after open or laparoscopic surgery of hemicolectomy patients before and after implementation of the preoperative anaesthesia assessment clinic (PAC).
The secondary outcome is to evaluate the patients' characteristics, the main events leading to cancellations and the consequences this brings to the patient and the hospital.
Adverse events reported pre-and post-intervention will be analysed. Patient characteristics will be collected: age, gender, diagnosis, reason and type of surgery, patient admission, assessed in PAC or not, ASA classification (American Society of Anesthesiologist Classification system), who performed the assessment (anaesthetic nurse or anaesthesiologist), type of anaesthesia, former diagnosis/disease with impact on anaesthesia/surgery, present smoker, allergies, blood samples, other examinations, cancellation of surgery, reasons and consequences for cancellations, time of anaesthetic assessment before surgery, intraoperative events, mallampati, Intubation grade, BMI and type of medication.
A specific data collection form will be developed and the data will be collected retrospectively from patient journals.
The number is calculated to: n = 588, n = 294 before and after the implementation of PAC. We use a significance level of 5%. To achieve statistical strength of 80% (beta = 20%), we need 288 patients before and after PAC to detect a difference of at least 10%. Given that we have the opportunity to include many more then we assume that our study has adequate strength. Prevalences of cancellations are estimated as shares and presented with 95% confidence intervals (CIs) calculated using the exact method. Possible differences in background variables in patients included before and after the implementation of PAC will be estimated using kji-square tests or t-tests. The effect of the implementation of PAC will be estimated using logistic regression adjusted for possible confounding factors and results will be presented as adjusted odds ratio (OR) with 95% CI.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre- Preanaesthesia assessment clinic | – | –Patients who have been to surgery for an elective laparoscopic or open partial intestine from 2014-2017. |
| Post- Preanaesthesia assessment clinic | – | –Patients who have been to surgery for an elective laparoscopic or open partial intestine from 2017 and have attended a preanesthesia clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have been to surgery for open or laparoscopic partial excision of the intestine.
Key inclusion criteria (4 listed)
- Patients over 18 years old.
- Open or laparoscopic surgery on elective patients after partial excision of the intestine.
- Patients following the ERAS (Enhanced recovery after surgery) protocol after the year 2014.
- Patients who attended PAC after the year 2017 and were assessed by anesthesia staff.
Key exclusion criteria (1 listed)
- Emergency patients
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
Cancellation rate, Intraoperative events
Time frame: 2014-2022
Incidence of Cancellation rate and unanticipated intraoperative events
1 secondary outcome
Patient's characteristics , cancellation main events and concequenses.
Time frame: 2014-2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 40506071Kristoffersen EW, Fossum M, Tveit TO, Berge GT, Hagen MC, Opsal A. Comparison of elective hemicolectomy patients before and after establishment of a preoperative anaesthesia assessment clinic: a retrospective, observational study in a hospital in Norway. BMJ Open. 2025 Jun 12;15(6):e100922. doi: 10.1136/bmjopen-2025-100922.
- Individual participant dataSharing planned: Undecided
Related trials for Preoperative Anaesthesia Clinic
Recruiting
Redesigning the Surgical Pathway (PROMoTE)
Delirium, Cognitive Impairment
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anaesthesia Clinic and Cancellation Rate, run by University of Agder.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eirunn Kristoffersen, Master (+4795207238, eirunn.w.kristoffersen@uia.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancellation rate, Intraoperative events (time frame: 2014-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05520229, which also lists 1 linked publication.
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 2 Nov 2022.