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临床试验/NCT05930769
NCT05930769已完成不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Operation duration (in minute)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

结局指标

主要结局

Operation duration (in minute)

时间窗: 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.

次要结局

  • Conversion from laparoscopy to laparotomy(In the intra-operative phase of the study)
  • 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)
  • 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))
  • 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)
  • Comments related to the set up of AR (according to the surgical report)(In the intra-operative phase of the study)
  • Total time of hospitalization (in day)(From the date of hospital admission to the date of hospital discharge assessed up to 1 week)
  • Pregnancy obtention follow-up(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 ;(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(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))

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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