Clinical trial NCT05930769: Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021 (ImpactRA)
Official title: Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myoma;Uterus
Adenomyoma of Uterus
Keywords: Augmented Reality
Uterine myomectomy
Uterine adenomyomectomy
Laparoscopic surgery
Minimally invasive surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged between 18-84 years old that were indicated for an laparoscopic myomectomy or laparoscopic adenomyomectomy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Operation duration (in minute)
timeFrame: In the intra-operative phase of the study
Secondary outcomes:
measure: Amount of bleeding (in mL)
timeFrame: In the intra-operative phase of the study
measure: 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).
timeFrame: In the post-operative phase of the study
measure: 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
timeFrame: In the intra-operative phase of the study
measure: Conversion from laparoscopy to laparotomy
timeFrame: In the intra-operative phase of the study
measure: Comments related to the set up of AR (according to the surgical report)
timeFrame: In the intra-operative phase of the study
measure: Total time of hospitalization (in day)
timeFrame: From the date of hospital admission to the date of hospital discharge assessed up to 1 week
measure: Time between discharge from hospital and the last post-operative visit (in months)
timeFrame: 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)
measure: Pregnancy obtention follow-up
timeFrame: 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)
measure: Adenomyosis / myoma(s) recurrence from 6 months after the operation ;
timeFrame: 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)
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: pchauvet@chu-clermontferrand.fr
name: Pauline CHAUVET
role: PRINCIPAL_INVESTIGATOR
References: