Study Of The Metabolic Parameters Of Uterine Muscle Cells

Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign

To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time.

Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.

Study Overview

• Status: Completed
• Conditions: Ischemia

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service de Gynécologie - CMCO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies

Description

Inclusion criteria:

• - Adult patient
• Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies (fibroma, adenomyosis, genital prolapse,...) within the CMCO
• Patient consenting to the use of cells from her uterus for incineration for research purposes
• Patient giving her consent for the use of her medical data for the purposes of this research.
• Patient agreeing to participate in the study

Exclusion criteria:

• - Patient refusing to participate in the study
• Patient under the protection of justice
• Patient under guardianship or curatorship
• Suspicion of gynaecological malignant pathology
• Pregnant or breastfeeding woman
• Impossibility to give the subject informed information (difficulties in understanding the subject...)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemia	Study physiologically the time of ischemia of the uterine muscle 1 hour after sampling	1 hour after sampling

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Study Director: Olivier GARBIN, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): December 13, 2020
• Study Completion (Actual): December 13, 2020

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Hysterotomy; UTERINE MUSCLE CELLS; ISCHEMIA; COLD ISCHEMIA
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 7222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No