Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021 (ImpactRA)
- Conditions
- Myoma;UterusAdenomyoma of Uterus
- Interventions
- Procedure: Gynecological laparoscopic surgery without augmented realityProcedure: Gynecological laparoscopic surgery with augmented reality
- Registration Number
- NCT05930769
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 49
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Gynecological laparoscopic surgery without augmented reality Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, without augmented reality (AR). Case group Gynecological laparoscopic surgery with augmented reality Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, with augmented reality (AR).
- Primary Outcome Measures
Name Time Method Operation duration (in minute) In the intra-operative phase of the study Assessment of the use of augmented reality during gynecologic laparoscopy defined by the non-increase of the operation time.
- Secondary Outcome Measures
Name Time Method Conversion from laparoscopy to laparotomy In the intra-operative phase of the study Estimating the impact of AR on the conversion rate (laparoscopy to laparotomy)
Amount of bleeding (in mL) In the intra-operative phase of the study Estimating the impact of AR on the amount of bleeding
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). In the post-operative phase of the study 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.
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) Estimating the impact of AR on the time between discharge from hospital and the last post-operative visit (in months)
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 In the intra-operative phase of the study Estimating the impact of AR on the intra-operative complication rate
Comments related to the set up of AR (according to the surgical report) In the intra-operative phase of the study 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
Total time of hospitalization (in day) From the date of hospital admission to the date of hospital discharge assessed up to 1 week Estimating the impact of AR on hospitalization duration
Pregnancy obtention follow-up 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) Estimating the impact of AR on the frequency of post-operative pregnancy
Adenomyosis / myoma(s) recurrence from 6 months after the operation ; 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) Estimating the impact of AR on the frequency of recurrence greater than 6 months
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 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) Estimating the impact of AR on the post-operative complication rate
Trial Locations
- Locations (1)
CHU clermont-ferrand
🇫🇷Clermont-Ferrand, France