Myoma;UterusImpactRANCT05930769
Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021 (ImpactRA)
An observational study of Myoma;Uterus and Adenomyoma of Uterus, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years, women only
- Conditions the study is for
- Myoma;Uterus, Adenomyoma of Uterus
- What is being tested?
- Gynecological laparoscopic surgery without augmented reality and Gynecological laparoscopic surgery with augmented reality
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged between 18-84 years old that were indicated for an laparoscopic myomectomy or laparoscopic adenomyomectomy.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myoma;Uterus, Adenomyoma of Uterus
- Being tested
- Gynecological laparoscopic surgery without augmented reality, Gynecological laparoscopic surgery with augmented reality
- Keywords
- Augmented Reality, Uterine myomectomy, Uterine adenomyomectomy, Laparoscopic surgery, Minimally invasive surgery
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecological laparoscopic surgery without augmented realityProcedure or surgery
Minimally invasive gynecological surgery assisted by laparoscope.
Gynecological laparoscopic surgery with augmented realityProcedure or surgery
Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, with augmented reality (AR). Receives: Procedure: Gynecological laparoscopic surgery with augmented reality | |
| Control group | Patients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, without augmented reality (AR). Receives: Procedure: Gynecological laparoscopic surgery without augmented reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation duration (in minute)
Assessment of the use of augmented reality during gynecologic laparoscopy defined by the non-increase of the operation time.
Measured: In the intra-operative phase of the study
Secondary outcomes (10)
Amount of bleeding (in mL)
Estimating the impact of AR on the amount of bleeding
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: In the intra-operative phase of the study
Total time of hospitalization (in day)
Estimating the impact of AR on hospitalization duration
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2022
- Primary completion22 Sep 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline CHAUVET, Principal investigator, pchauvet@chu-clermontferrand.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930769
- Sponsor's protocol ID
- 2022-CF016.
- Acronym
- ImpactRA
- Status last verified
- Jul 2025
- First submitted
- 31 May 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021
- ClinicalTrials.gov ID
- NCT05930769
- Acronym / sponsor ID
- ImpactRA / 2022-CF016.
- Conditions
- Myoma;Uterus, Adenomyoma of Uterus
- Keywords
- Augmented Reality, Uterine myomectomy, Uterine adenomyomectomy, Laparoscopic surgery, Minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Procedure: Gynecological laparoscopic surgery with augmented realityPatients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, with augmented reality (AR). |
| Control group | – | Procedure: Gynecological laparoscopic surgery without augmented realityPatients that have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, without augmented reality (AR). |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged between 18-84 years old that were indicated for an laparoscopic myomectomy or laparoscopic adenomyomectomy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynecological laparoscopic surgery without augmented realityMinimally invasive gynecological surgery assisted by laparoscope. | Procedure or surgery | Control group |
| Gynecological laparoscopic surgery with augmented realityMinimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality. | Procedure or surgery | Case group |
Primary outcome
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.
10 secondary outcomes
Amount of bleeding (in mL)
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).
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
Time frame: In the intra-operative phase of the study
Conversion from 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)
Time frame: 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
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
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 ;
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline CHAUVET principal investigator
pchauvet@chu-clermontferrand.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myoma;Uterus and Adenomyoma of Uterus, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation duration (in minute) (time frame: In the intra-operative phase of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.