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Trial Title:
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
Condition:
Myoma;Uterus
Adenomyoma of Uterus
Conditions: Official terms:
Leiomyoma
Myofibroma
Adenomyoma
Conditions: Keywords:
Augmented Reality
Uterine myomectomy
Uterine adenomyomectomy
Laparoscopic surgery
Minimally invasive surgery
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Gynecological laparoscopic surgery without augmented reality
Description:
Minimally invasive gynecological surgery assisted by laparoscope.
Arm group label:
Control group
Intervention type:
Procedure
Intervention name:
Gynecological laparoscopic surgery with augmented reality
Description:
Minimally invasive gynecological surgery assisted by laparoscope with the display of
additional information through augmented reality.
Arm group label:
Case group
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.
Criteria for eligibility:
Study pop:
Women aged between 18-84 years old that were indicated for an laparoscopic myomectomy or
laparoscopic adenomyomectomy.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
84 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU clermont-ferrand
Address:
City:
Clermont-Ferrand
Country:
France
Start date:
June 1, 2022
Completion date:
December 1, 2023
Lead sponsor:
Agency:
University Hospital, Clermont-Ferrand
Agency class:
Other
Source:
University Hospital, Clermont-Ferrand
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05930769
