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

Myoma;Uterus Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05930769
• Other study ID #: 2022-CF016.
• Status: Active, not recruiting
• Start date: June 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 1, 2023
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus

Intervention

Procedure:
• Gynecological laparoscopic surgery without augmented reality
Minimally invasive gynecological surgery assisted by laparoscope.
• Gynecological laparoscopic surgery with augmented reality
Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amount of bleeding (in mL)	Estimating the impact of AR on the amount of bleeding	In the intra-operative phase of the study
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)