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

August 19, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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