Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021 (ImpactRA)

NCT ID: NCT05930769

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-01

Brief Summary

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ImpactRA is an observational retrospective study. The management of the patient is not modified by this study. This study will be carried out based on the already existing data of the gynecological ward of CHU Clermont-Ferrand between 2016 and 2021. During this period of time, 17 patients have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, aided by augmented reality (AR). The investigators compared these 17 patients that underwent surgery with AR with 17 control patients that underwent the same surgery with the same indication but without AR.

Detailed Description

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Conditions

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Myoma;Uterus Adenomyoma of Uterus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case group

Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, with augmented reality (AR).

Gynecological laparoscopic surgery with augmented reality

Intervention Type PROCEDURE

Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.

Control group

Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, without augmented reality (AR).

Gynecological laparoscopic surgery without augmented reality

Intervention Type PROCEDURE

Minimally invasive gynecological surgery assisted by laparoscope.

Interventions

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Gynecological laparoscopic surgery without augmented reality

Minimally invasive gynecological surgery assisted by laparoscope.

Intervention Type PROCEDURE

Gynecological laparoscopic surgery with augmented reality

Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 (included) and 84 (Included),
* Patient operated between 2017\* et 2021,
* Patient with one or more intrauterine myomas, with surgical treatment by laparoscopic myomectomy with or without AR,
* Patient with one or more intrauterine adenomyomas, with surgical treatment by laparoscopic adenomyomectomy with or without AR,
* Patient informed about the use of her data for research.

Exclusion Criteria

* Patient who refused the use of medical data for research purposes,
* Patient operated prior to 2017\* and after 2021,
* Patient whose medical follow-up did not allow collection of the data required for the study.

(\*) An amendment validated by the ethics committee allows inclusion of patients operated during 2016
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pauline CHAUVET

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2022-CF016.

Identifier Type: -

Identifier Source: org_study_id

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