NCT05930769

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myoma;Uterus
• Adenomyoma of Uterus

Interventions

Type	Name	Description
PROCEDURE	Gynecological laparoscopic surgery without augmented reality	Minimally invasive gynecological surgery assisted by laparoscope.
PROCEDURE	Gynecological laparoscopic surgery with augmented reality	Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-09-22
• Completion: 2023-12-01
• First posted: 2023-07-05
• Last updated: 2025-08-24

Locations

1 site across 1 country: France