Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery
COELIOCOM
1 other identifier
observational
10
1 country
1
Brief Summary
An increasing number of surgeries are being performed using laparoscopic techniques. This approach significantly reduces postoperative pain and speeds up recovery. Additionally, the resulting scars are smaller compared to open surgeries. This study evaluates the quality of care and communication satisfaction among parents of children undergoing laparoscopic surgery in the pediatric surgery department of Brest. The primary goal is to assess parental satisfaction with communication during the procedure. Parents of children who have undergone laparoscopic surgery will be invited to participate. Participants will complete a satisfaction questionnaire the day after surgery and participate in a follow-up phone interview 7 to 9 days post-surgery, incorporating the child's opinion if possible.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2024
Shorter than P25 for all trials
1 active site
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
June 3, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedStudy Start
First participant enrolled
July 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2024
CompletedOctober 16, 2024
October 1, 2024
2 months
June 3, 2024
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Parent satisfaction score
Mean of the 2 scores on the post-laparoscopy satisfaction questionnaires at inclusion and during the telephone interview (from 0 not at all satisfied to 100 totally satisfied). Using a Likert scale, each of the 20 items in the questionnaire will be evaluated with a score between 0 (not at all satisfied) and 5 (totally satisfied). Then the sum of the scores for each item will be calculated to obtain an overall score between 0 (not at all satisfied) and 100 (totally satisfied)
day of inclusion and 7 to 9 days after laparoscopic surgery
Secondary Outcomes (4)
Parent satisfaction
7 to 9 days after laparoscopic surgery
Quality of care
day of inclusion and 7 to 9 days after laparoscopic surgery
Parent satisfaction
day of inclusion and 7 to 9 days after laparoscopic surgery
Quality of care
about 2 days
Study Arms (1)
Parents accompanying children
Parents accompanying children aged 0 to 17 who have undergone laparoscopic surgery in the paediatric surgery department in Brest.
Interventions
Use of a post-laparoscopy satisfaction questionnaire designed to be adapted to the context of laparoscopic surgery. This post-laparoscopy questionnaire was inspired by the PedsQL generic care satisfaction questionnaire, a standardised and validated questionnaire.
Eligibility Criteria
Parents accompanying children undergoing laparoscopic surgery in the paediatric department in Brest.
You may qualify if:
- Accompanying parents of children from 0 to 17 years of age
- Accompanying parents of children treated by one of the following laparoscopic procedures: laparoscopy and thoracoscopy, laparoscopies requiring a mini-laparotomy for extraction of the part, and laparoscopies carried out on an outpatient basis.
- No objection from the parent accompanying the child
You may not qualify if:
- Parents who are minors
- Parents under legal protection (guardianship, curatorship) or deprived of liberty
- Need for intraoperative conversion.
- Insufficient knowledge of the French language to complete the post-laparoscopy satisfaction questionnaire.
- Not affiliated to the social security system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Brest
Brest, Brest, 29200, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2024
First Posted
June 7, 2024
Study Start
July 22, 2024
Primary Completion
September 23, 2024
Study Completion
September 23, 2024
Last Updated
October 16, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning five years and ending fifteen years following the final study report completion.
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
All collected data that underlie results in a publication