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Completed

NCT Number: NCT05930769

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

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.

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Key information

Conditions

Myoma;Uterus Adenomyoma of Uterus Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–84 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gynecological laparoscopic surgery without augmented reality

Procedure

Minimally invasive gynecological surgery assisted by laparoscope.

Gynecological laparoscopic surgery with augmented reality

Procedure

Minimally invasive gynecological surgery assisted by laparoscope with the display of additional information through augmented reality.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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)

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: ImpactRA

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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