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CompletedNCT05743803BreakFastUpdated Sep 28, 2023

Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study

An observational study in Fasting, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
364
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Fasting

Keywords

  • fasting
  • quality of recovery
  • surgery
03

In context

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • Adult undergoing a surgical procedure.

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
364 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSensititization campaign on preoperative fasting rules

    * 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.

06

What researchers measure

Primary outcomes

  1. Fasting time

    Liquid and solid fasting time before surgery (minutes)

    Time frame: Before surgery

Secondary outcomes

  1. Preoperative oral carbohydrate loading

    Rate of oral cardbohydrate intake in the 2 hours preoperative period (percentage)

    Time frame: 2 hours preoperative period

  2. Fasting exceeding 12 hours

    Rate of fasting duration superior to 12 hours (liquid or solid) (percentage)

    Time frame: Before surgery

  3. Preoperative anxiety

    Scale of preoperative anxiety from 0 (no anxiety) to 10 (maximum anxiety possible)

    Time frame: Before surgery

  4. Preoperative discomfort

    Scale of preoperative disomfort from 0 (no discomfort) to 10 (maximum discomfort possible)

    Time frame: Before surgery

  5. Feeling of thirst

    Qualitative scale of preoperative thirst (none, moderate, significant)

    Time frame: Before surgery

  6. Feeling of hunger

    Qualitative scale of preoperative hunger (none, moderate, significant)

    Time frame: Before surgery

  7. Preoperative nausea or vomiting

    Rate of nausea or vomit in the preoperative period (percentage)

    Time frame: Before surgery

  8. Rate of postoperative nausea or vomiting

    Rate of nausea or vomit during the post-operative period (percentage)

    Time frame: Day of surgery

  9. Patient satisfaction toward communication and explanation about preoperative fasting.

    Binary answer (yes or no)

    Time frame: Day of surgery

  10. Post-operative quality of recovery

    French Quality of Recovery 15 score (

    Time frame: Day 1 after surgery

  11. Length of stay

    Length of stay (days)

    Time frame: Maximum 30 days follow up

  12. Post-operative surgical complication

    Clavien-dindo classification from 0 (no complication) to 5 (death)

    Time frame: Maximum 30 days follow up

07

Study locations

1 site
  • CHU Angers
    Angers, 49000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05743803
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Feb 24, 2023
Start date
Feb 27, 2023
Primary completion
Jul 20, 2023
Completion
Aug 20, 2023
Last update
Sep 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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