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.
Study Type
OBSERVATIONAL
Enrollment
49
Minimally invasive gynecological surgery assisted by laparoscope.
Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.
CHU clermont-ferrand
Clermont-Ferrand, France
Operation duration (in minute)
Assessment of the use of augmented reality during gynecologic laparoscopy defined by the non-increase of the operation time.
Time frame: In the intra-operative phase of the study
Amount of bleeding (in mL)
Estimating the impact of AR on the amount of bleeding
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: In the intra-operative phase of the study
Total time of hospitalization (in day)
Estimating the impact of AR on hospitalization duration
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
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