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

June 29, 2023 updated by: University Hospital, Clermont-Ferrand

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women aged between 18-84 years old that were indicated for an laparoscopic myomectomy or laparoscopic adenomyomectomy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation duration (in minute)
Time Frame: 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.
In the intra-operative phase of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of bleeding (in mL)
Time Frame: In the intra-operative phase of the study
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).
Time Frame: 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.
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
Time Frame: In the intra-operative phase of the study
Estimating the impact of AR on the intra-operative complication rate
In the intra-operative phase of the study
Conversion from laparoscopy to laparotomy
Time Frame: In the intra-operative phase of the study
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)
Time Frame: 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
In the intra-operative phase of the study
Total time of hospitalization (in day)
Time Frame: 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
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)
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)
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
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)
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 ;
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)
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
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Pauline CHAUVET, pchauvet@chu-clermontferrand.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

September 22, 2022

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-CF016.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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