NCT06602310

Brief Summary

The use of web based self-assessment questionnaires as a complementary tool for conducting preoperative assessment (POA) is gaining increasing acceptance. Preanestes@s2.0 is a web based application fully developed by the investigators team which potentially allows for remote non-telephonic POA. It has already been evaluated as a feasible tool in terms of patient acceptance and quality of the information recorded. In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal POA when the participants are evaluated through Preanestes@s2.0 versus the traditional outpatient face to face visit. The investigators will consider as suboptimal any POA that potentially may generate an inadequate preparation of the patient which may affect the expected results. A total 1.127 participants will be evaluated through Preanestes@s2.0 (intervention arm) and compared to a cohort of 1.127 patients evaluated by traditional face-to-face interview (non-intervention arm). The comparison will be made by means of a propensity score matching study. Patients included in both arms of the study will be recruited throughout the same period of time.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2,254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

September 16, 2024

Last Update Submit

July 21, 2025

Conditions

Keywords

Electronic Health RecordsHealth Impact AssessmentPatient Health QuestionnairePreoperative Period

Outcome Measures

Primary Outcomes (1)

  • Suboptimal preoperative assessments (SOPA).

    Dichotomous (present/absent) composite variable comprising any of the following: 1. Lack of relevant information in the preoperative assessment that conducts to: - Inadequate conciliation of chronic medication - Inadequate preoperative fasting - Inadequate register of clinical or functional conditions that may cause delayed intervention the day of surgery (presence of uncontrolled chronic diseases, presence of impaired functional status undetected in the preoperative assessment, etcetera. 2. Lack of complementary tests indicated according to preoperative protocol 3. Presence of not indicated complementary tests according to preoperative protocol 4. Lack of properly filled informed consent 5. Cancellation of the intervention due to inadequate preoperative preparation (attributable to mismanagement of preoperative information)

    From the day of intervention up to 7 days after intervention

Study Arms (2)

Preanestes@s2.0: web-based non-face-to-face preoperative assessment. Telematic group.

EXPERIMENTAL

Participants will be leaded through preoperative period on a web based application. Participants will be addressed to either virtual or telephone POA on the basis of the information registered in the web based preoperative questionnaire that the application incorporates. Virtual assessment will be performed by evaluating both the filled web based questionnaire together with participants´ electronic medical records. Telephone assessment will also incorporate a telephone call for further clarifications.

Other: Web based preoperative assessment

Traditional face-to-face preoperative assessment

NO INTERVENTION

Participants will be leaded through preoperative period following traditional institutional standards of care. Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records.

Interventions

Preoperative assessment conducted through a web based application. Telematic non-face-to-face preoperative assessment.

Preanestes@s2.0: web-based non-face-to-face preoperative assessment. Telematic group.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants undergoing day scheduled surgery in our institutions: Hospitales Universitarios Virgen del Rocío y Virgen Macarena.
  • Surgical specialities included: Urology, General Surgery, Orthopedics, Ear, nose, and throat surgery.

You may not qualify if:

  • Urgent procedures, oncologic procedures, patients without the ability to understand informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen Del Rocío

Seville, 41013, Spain

Location

Related Publications (13)

  • Goodhart IM, Andrzejowski JC, Jones GL, Berthoud M, Dennis A, Mills GH, Radley SC. Patient-completed, preoperative web-based anaesthetic assessment questionnaire (electronic Personal Assessment Questionnaire PreOperative): Development and validation. Eur J Anaesthesiol. 2017 Apr;34(4):221-228. doi: 10.1097/EJA.0000000000000545.

  • Arias A, Benitez S, Canosa D, Borbolla D, Staccia G, Plazzotta F, Casais M, Michelangelo H, Luna D, Bernaldo de Quiros FG. Computerization of a preanesthetic evaluation and user satisfaction evaluation. Stud Health Technol Inform. 2010;160(Pt 2):1197-201.

  • Zaballos M, Lopez-Alvarez S, Argente P, Lopez A; Grupo de Trabajo de Pruebas Preoperatorias. Preoperative tests recommendations in adult patients for ambulatory surgery. Rev Esp Anestesiol Reanim. 2015 Jan;62(1):29-41. doi: 10.1016/j.redar.2014.07.007. Epub 2014 Aug 18. English, Spanish.

  • De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.

  • Kinley H, Czoski-Murray C, George S, McCabe C, Primrose J, Reilly C, Wood R, Nicolson P, Healy C, Read S, Norman J, Janke E, Alhameed H, Fernandes N, Thomas E. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial. BMJ. 2002 Dec 7;325(7376):1323. doi: 10.1136/bmj.325.7376.1323.

  • Conde JM, Moreno-Conde A, Salas-Fernandez S, Parra-Calderon CL. ITCBio, a Clinical and Translational Research Platform. AMIA Annu Symp Proc. 2020 Mar 4;2019:673-680. eCollection 2019.

  • Lozada MJ, Nguyen JT, Abouleish A, Prough D, Przkora R. Patient preference for the pre-anesthesia evaluation: Telephone versus in-office assessment. J Clin Anesth. 2016 Jun;31:145-8. doi: 10.1016/j.jclinane.2015.12.040. Epub 2016 Apr 15.

  • Law TT, Suen DT, Tam YF, Cho SY, Chung HP, Kwong A, Yuen WK. Telephone pre-anaesthesia assessment for ambulatory breast surgery. Hong Kong Med J. 2009 Jun;15(3):179-82.

  • Ludbrook G, Seglenieks R, Osborn S, Grant C. A call centre and extended checklist for pre-screening elective surgical patients - a pilot study. BMC Anesthesiol. 2015 May 19;15:77. doi: 10.1186/s12871-015-0057-1.

  • Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopena MM, Manoso Noriego M. [Online versus non-standard face to face preoperative assessment: cost effectiveness]. Rev Esp Anestesiol Reanim. 2012 Aug-Sep;59(7):350-6. doi: 10.1016/j.redar.2012.05.039. Epub 2012 Jul 10. Spanish.

  • Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.

  • de la Matta M, Alonso-Gonzalez M, Moreno-Conde J, Salas-Fernandez S, Lopez-Romero JL; Preanestesas study investigators. Development and patient acceptance of Preanestes@s, a web-based application and electronic questionnaire for preoperative assessment. A prospective cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Aug-Sep;69(7):383-392. doi: 10.1016/j.redare.2022.01.002. Epub 2022 Jul 20.

  • de la Matta M, Alonso-Gonzalez M, Garcia-Santigosa M, Arance-Garcia M, Sanchez-Pena J, Castro-Linan LM, Lopez-Romero JL. Accuracy and Comprehensiveness in Recording Information of a Web-Based Application for Preoperative Assessment: A Prospective Observational Study. J Perianesth Nurs. 2023 Jun;38(3):440-447. doi: 10.1016/j.jopan.2022.08.004. Epub 2022 Dec 9.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

June 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 20, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations