NCT06447298

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

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

June 3, 2024

Last Update Submit

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.

Other: Satisfaction questionnaires

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.

Parents accompanying children

Eligibility Criteria

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

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

Location

Related Links

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

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

All collected data that underlie results in a publication

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.

Locations