Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery (COELIOCOM)

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.

Study Overview

• Status: Completed
• Conditions: Communication; Pediatric Surgery; Parent's Satisfaction; Children Laparoscopic Surgery; Coelioscopy
• Intervention / Treatment: Other: Satisfaction questionnaires

Detailed Description

Laparoscopic surgery, also known as laparoscopy and thoracoscopy, is increasingly used in pediatric surgery. This technique involves performing procedures through small incisions using miniaturized instruments and a camera, allowing precise, real-time operation. Laparoscopy offers several advantages over traditional open surgery, such as reduced surgical trauma, shorter recovery times, smaller scars, and lower risks of complications like infections and bleeding. Despite these benefits, research on patient experience with laparoscopy is limited, particularly regarding communication between patients and healthcare teams. This study aims to assess the satisfaction of parents whose children undergo laparoscopic surgery, focusing on communication and care quality. Previous studies indicate that patient satisfaction is a critical independent measure of care quality, not necessarily linked to clinical outcomes. Enhancing patient satisfaction can also reduce postoperative complications and improve recovery.

Using a custom satisfaction questionnaire based on the standardized and validated PedsQL generic care satisfaction questionnaire, this study will evaluate parental satisfaction with communication and care regarding their child's laparoscopic surgery. Parents will complete a satisfaction questionnaire the day after surgery and participate in a follow-up phone interview 7 to 9 days post-surgery, considering the child's input if possible.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).

The primary objective of this study is to evaluate parental satisfaction with communication after their child's laparoscopic surgery by averaging the satisfaction scores from the initial post-laparoscopy questionnaire and the follow-up telephone interview (scored from 0 to 100).

For secondary objectives, responses to open-ended questions during the telephone interview will be qualitatively analyzed to gain insights into specific aspects of the parental experience with laparoscopy. The quality of care will be assessed using scores from specific items on the questionnaires related to care quality. Additionally, the study will analyze the duration of hospitalization to explore any correlation with parental satisfaction. The evolution of satisfaction over time will be assessed by comparing initial satisfaction scores with short-term satisfaction scores obtained during the follow-up interview. This comparison aims to identify any changes in satisfaction levels, particularly concerning the post-discharge period. All data will be analyzed using descriptive statistics for frequency and mean scores, with further analysis conducted using the software Prism to ensure robustness and validity of the findings.

At the end of this study, investigators hope to identify areas for improvement in surgical care and communication, aiming to enhance the postoperative quality of life for pediatric patients.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Chu Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Parents accompanying children undergoing laparoscopic surgery in the paediatric department in Brest.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent satisfaction	Responses to open questions about laparoscopy during the telephone interview	7 to 9 days after laparoscopic surgery
Quality of care	Independent analysis of scores on quality of care items	day of inclusion and 7 to 9 days after laparoscopic surgery
Parent satisfaction	Comparison of initial satisfaction (paper post-laparoscopy satisfaction questionnaire at inclusion) with short-term satisfaction (telephone call post-laparoscopy satisfaction questionnaire between the 7th and 9th day after laparoscopic surgery).	day of inclusion and 7 to 9 days after laparoscopic surgery
Quality of care	Length of hospital stay	about 2 days

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): September 23, 2024

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 29BRC24.0129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No