NCT03355404

Brief Summary

For 25 years, the concept of Rapid Rehabilitation After Surgery or RRAC has developed to bring about a global care of the patient by establishing a safe and quality climate. With this concept of RRAC or fast track surgery, it is the idea that a patient will recover sooner than he is lying later. "Fast care" is based on the principle that any patient is valid before he / be operated and therefore do not need to come to a bed in the operating room. The ambulatory surgery department of the CHU of Caen welcomes and supports adults and children over 8 years old. The following specialties are covered: dental surgery and stomatology, digestive and visceral surgery, orthopedic surgery, otolaryngological surgery, vascular surgery, gynecological surgery, urological surgery. The ambulatory surgery unit is experimenting with patient support at the operating theater on foot by the service stretcher team since December 2015. It seems that this technique makes it possible to improve the quality of care by respecting the dignity and autonomy; in fact to wander the patient preserves his glasses, his hearing aids, capillary prosthesis ... The patient is an actor and not dependent, he is accompanied and not taken away. The preservation of autonomy improves their feelings, especially in terms of dignity. It also appears to be a technique for participating in the reduction of preoperative anxiety, an important factor for postoperative follow-up. However, studies reporting the benefit of this technique have rather evaluated the feelings of patients. To the best of our knowledge, there are no studies that have evaluated their benefit on anxiety reduction by questionnaires or ad hoc scales. Assessing anxiety with appropriate tools seems essential to determine a real impact. We hypothesize that accompanying the patient to the operating room on foot would reduce preoperative anxiety. We have not yet found any studies showing that the "standing patient" pathway had an impact on preoperative anxiety. We propose to carry out a randomized study comparing the anxiety score using the APAIS scale at the operating room installation between patients benefiting from the "standing patient pathway" versus the patients receiving the care standard, that is to say the stretcher transport to the operating theater. The duration of this study is evaluated at 2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,217

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started May 2018

Typical duration for not_applicable surgery

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

November 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

November 22, 2017

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • APAIS score to the operating room installation

    APAIS scale

    baseline

Study Arms (2)

"Standing Patient"

EXPERIMENTAL
Other: standing patient

"Standardized management in stretcher"

NO INTERVENTION

Interventions

patient goes standing to the surgery room

"Standing Patient"

Eligibility Criteria

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

You may qualify if:

  • Major patient.
  • Patient hospitalized for surgery.
  • Patient supported in the south block.
  • Patients agreeing to participate in the study.
  • Patient speaking and understanding French.

You may not qualify if:

  • Patient with reduced mobility.
  • Patient with a mental disability.
  • Patient suffering from a severe psychiatric pathology.
  • Major patient protected.
  • Patient does not speak or understand French.
  • Refusal of the patient to participate in the study.
  • Patient who has been premedicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 28, 2017

Study Start

May 7, 2018

Primary Completion

April 22, 2021

Study Completion

June 1, 2021

Last Updated

April 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations