Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyoma of Uterus | — | UNRESOLVED | — |
| Myoma;Uterus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gynecological laparoscopic surgery with augmented reality | Procedure | — | UNRESOLVED |
| Gynecological laparoscopic surgery without augmented reality | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case group
- description
- Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, with augmented reality (AR).
- interventionNames
- Procedure: Gynecological laparoscopic surgery with augmented reality
- label
- Control group
- description
- Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, without augmented reality (AR).
- interventionNames
- Procedure: Gynecological laparoscopic surgery without augmented reality
Primary outcomes (1)
- measure
- Operation duration (in minute)
- timeFrame
- In the intra-operative phase of the study
- description
- Assessment of the use of augmented reality during gynecologic laparoscopy defined by the non-increase of the operation time.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 84 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available