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

NCT05930769 | Completed

• 1 other identifier: 2022-CF016.
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myoma;Uterus; Adenomyoma of Uterus

Keywords

Augmented Reality; Uterine myomectomy; Uterine adenomyomectomy; Laparoscopic surgery; Minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Amount of bleeding (in mL)

  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).

  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

  In the intra-operative phase of the study

• Conversion from laparoscopy to laparotomy

  In the intra-operative phase of the study

• Comments related to the set up of AR (according to the surgical report)

  In the intra-operative phase of the study

Study Arms (2)

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

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

Interventions

Gynecological laparoscopic surgery without augmented reality PROCEDURE

Minimally invasive gynecological surgery assisted by laparoscope.

Control group

Gynecological laparoscopic surgery with augmented reality PROCEDURE

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

Case group

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pauline CHAUVET

  pchauvet@chu-clermontferrand.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 5, 2023
• Study Start: June 1, 2022
• Primary Completion: September 22, 2022
• Study Completion: December 1, 2023
• Last Updated: August 24, 2025

Record last verified: 2025-07

Locations

FR (1)