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

Study Overview
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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.

Official Title
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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

Conditions
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Myoma;Uterus, Adenomyoma of Uterus

Intervention / Treatment
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* Procedure: Gynecological laparoscopic surgery without augmented reality
* Procedure: Gynecological laparoscopic surgery with augmented reality


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, with augmented reality (AR). | Procedure: Gynecological laparoscopic surgery with augmented reality<br>* Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.<br>|
| Control group<br>Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, without augmented reality (AR). | Procedure: Gynecological laparoscopic surgery without augmented reality<br>* Minimally invasive gynecological surgery assisted by laparoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation duration (in minute) | Assessment of the use of augmented reality during gynecologic laparoscopy defined by the non-increase of the operation time. | In the intra-operative phase of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of bleeding (in mL) | Estimating the impact of AR on the amount of bleeding | In the intra-operative phase of the study | 
| Post-operative pain measured with the visual analogue scale (VAS) score (measure every day after the operation as well as at the end of hospitalization). | Estimating the impact of AR on the pain measured with the post-operative visual analogue scale (VAS) score. The score on this scale ranges from 0 to 10. The higher the score, the more pain the patient experienced at the time of filling in the scale. | In the post-operative phase of the study | 
| Intra-operative complication number and details (wounds of adjacent structures and organs, vascular wounds, opening of the uterine cavity, difficulties in locating the tumor) based on the comments of the surgical report | Estimating the impact of AR on the intra-operative complication rate | In the intra-operative phase of the study | 
| Conversion from laparoscopy to laparotomy | Estimating the impact of AR on the conversion rate (laparoscopy to laparotomy) | In the intra-operative phase of the study | 
| Comments related to the set up of AR (according to the surgical report) | Estimating the impact of AR in the operating room represented by its installation and use during the course of the surgical procedure and estimating the impact of AR on the complexity/difficulty of the procedure recorded in the surgical report | In the intra-operative phase of the study | 
| Total time of hospitalization (in day) | Estimating the impact of AR on hospitalization duration | From the date of hospital admission to the date of hospital discharge assessed up to 1 week | 
| Time between discharge from hospital and the last post-operative visit (in months) | Estimating the impact of AR on the time between discharge from hospital and the last post-operative visit (in months) | From the date of hospital discharge to the date of the latest post-operative visit, assessed up to the last available information for each specific patient (6 years) | 
| Pregnancy obtention follow-up | Estimating the impact of AR on the frequency of post-operative pregnancy | From the date of surgery to the date of the latest post-operative visit, assessed up to the last available information for each specific patient (6 years) | 
| Adenomyosis / myoma(s) recurrence from 6 months after the operation ; | Estimating the impact of AR on the frequency of recurrence greater than 6 months | From the date of the surgery to the date of the latest post-operative visit, assessed up to the last available information for each specific patient (6 years) | 
| Post-operative complications numbers and details (wounds of adjacent structures and organs, bleeding complications, reoperations, complications based on the Clavien-Dindo classification) based on the comments of the post-operative consultation | Estimating the impact of AR on the post-operative complication rate | From the date of the surgery to the date of the latest post-operative visit, assessed up to the last available information for each specific patient (6 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmented Reality, Uterine myomectomy, Uterine adenomyomectomy, Laparoscopic surgery, Minimally invasive surgery