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

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Adenomyoma of Uterus
Myoma;Uterus

Treatments

Procedure: Gynecological laparoscopic surgery with augmented reality
Procedure: Gynecological laparoscopic surgery without augmented reality

Study type

Observational

Funder types

Other

Identifiers

NCT05930769
2022-CF016.

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

Female

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

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

Trial design

49 participants in 2 patient groups

Case group
Description:
Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, with augmented reality (AR).
Treatment:
Procedure: Gynecological laparoscopic surgery with augmented reality
Control group
Description:
Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, without augmented reality (AR).
Treatment:
Procedure: Gynecological laparoscopic surgery without augmented reality

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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