NCT05092659

Brief Summary

Given the growing importance of placing the patient at the heart of care evaluation, the use of patient questionnaires such as Patient Reported Experience Measures (PREMS) or Patient-Reported Outcome Measures (PROMS) has become widespread in recent years. PROMS assess the outcomes of care, whereas PREMS assess the patient's experience of care. However, these tools only imperfectly reflect the patient's experience and only answer specific questions: satisfaction, pain management, waiting times, etc. Patients undergoing bariatric surgery will undergo major surgery that will have an impact on their subsequent quality of life. Preparing for this surgery is a lengthy process, involving various forms of support: psychological, nutritional, physical activity, and so on. Exploring patients' experiences in depth, based on their account of their care experience, can enable carers to better understand and apprehend this type of journey from a perspective closer to that of the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

September 22, 2021

Last Update Submit

January 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient experience of the care pathway

    Explain the bariatric surgery care pathway, based on the patient experience

    6 months

Secondary Outcomes (4)

  • Questionnaire

    3 months

  • Number of experiences collected

    3 months

  • Repeat surgeries

    3 months

  • Repeat hospitalizations

    3 months

Study Arms (1)

patient interviews

OTHER

Patient enrolled in a bariatric surgical pathway scheduled for visceral surgery.

Behavioral: Patient interview

Interventions

Each patient included will be interviewed 3 times : before surgery, 3 and 6 months after surgery

patient interviews

Eligibility Criteria

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

You may qualify if:

  • Major patient
  • Patient enrolled in a bariatric surgical pathway scheduled.
  • First bariatric surgery

You may not qualify if:

  • Refusal to participate
  • Non proficiency in spoken French
  • Previous bariatric surgery
  • Protected persons (patients under guardianship, pregnant or breastfeeding women, persons deprived of liberty, persons unable to express their non-objection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal Créteil

Créteil, 94000, France

Location

Related Publications (1)

  • Vignot M, Jung C, Bathaei S, Lazzati A, Gateau V, Angeli F, Delorenzo C. Patient experience in bariatric surgery: protocol of a French narrative inquiry and qualitative analysis. BMJ Open. 2024 Aug 12;14(8):e082528. doi: 10.1136/bmjopen-2023-082528.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 25, 2021

Study Start

March 28, 2023

Primary Completion

January 14, 2025

Study Completion

January 14, 2025

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations