NCT05743803

Brief Summary

The goal of this before and after observational study is to evaluate the impact of a global sensitization campaign (targeted on surgeons, anesthetist and patients) about pre-operative fasting in an adult population. The main questions it aims to answer are:

  • Does the sensitization campaign reduce fasting time?
  • Does reduce fasting time increase quality of post-operative recovery? Sensitization campaign will be performed between the before and after phases, it will include:
  • Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics.
  • Reminder display in surgical wards and consults.
  • Individualized fasting cards for patients.
  • Short message service reminder on pre-operative fasting rules for patients.
  • Medical fasting prescription with clear fasting times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

February 14, 2023

Last Update Submit

September 26, 2023

Conditions

Keywords

fastingquality of recoverysurgery

Outcome Measures

Primary Outcomes (1)

  • Fasting time

    Liquid and solid fasting time before surgery (minutes)

    Before surgery

Secondary Outcomes (12)

  • Preoperative oral carbohydrate loading

    2 hours preoperative period

  • Fasting exceeding 12 hours

    Before surgery

  • Preoperative anxiety

    Before surgery

  • Preoperative discomfort

    Before surgery

  • Feeling of thirst

    Before surgery

  • +7 more secondary outcomes

Study Arms (2)

Before

This group will undergo their preoperative fasting period as standard care.

After

This group will undergo their preoperative fasting period after the sensitization campaign about preoperative fasting rules.

Other: Sensititization campaign on preoperative fasting rules

Interventions

* Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics. * Reminder display in surgical wards and consults. * Individualized fasting cards for patients. * Short message service reminder on pre-operative fasting rules for patients. * Medical fasting prescription with clear fasting times.

After

Eligibility Criteria

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

All patients undergoing a surgical procedure (scheduled or urgent) at the CHU d'Angers (France) during the inclusion period.

You may qualify if:

  • \- Adult undergoing a surgical procedure.

You may not qualify if:

  • Already intubated patient before surgery.
  • Redo surgery during the same hospitalization
  • Medical indication of fasting (e.g : occlusive syndrome)
  • Patient unable to anwser the questionnaire.
  • Patient under lawful protection
  • Pregnant women
  • Minor (\<18 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 24, 2023

Study Start

February 27, 2023

Primary Completion

July 20, 2023

Study Completion

August 20, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations