Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. (transplant)

January 29, 2020 updated by: Barretos Cancer Hospital

Feasibility Assessment of Assisted Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. Description of the Donor and Recipient Surgical Technique.

Currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. The aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for both the donor and recipient patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Few cases have been performed worldwide by laparotomic and, more recently, laparoscopic and assisted robotic access pathways. This is a clinical trial with 6 participants (3 donors and 3 recipients) to investigate the feasibility of an assisted laparoscopic-robotic surgical access route for uterine removal in the donor patient in uterine transplants. In the receiving patient, conventional surgery (midline incision) will be performed for uterine transplantation and vascular anastomoses.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Recruiting
        • Barretos Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Desire for uterine transplantation as a donor of the uterus (with family relationship with the donor patient);
  • At least one pregnancy before

Exclusion Criteria:

  • comorbidities that contraindicate a surgical procedure
  • Women who do not understand the study;
  • Women subject to the regime that determines significant vulnerability to the participant (eg prisoners, indigenous, etc.)
  • ABO blood test mismatch between donor and recipient patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Uterus Transplantation
Patients undergo transplantation of the uterus from live donor.
Procedure: Transplantation of the uterus from live donor.
Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transplant sucess rate
Time Frame: 2 years after transplantation
Assessed by records from Barretos Cancer Hospital
2 years after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live births after uterus transplantion
Time Frame: 2 years after transplantation
Assessed by records from Barretos Cancer Hospital
2 years after transplantation
Pregnancy rate
Time Frame: 2 years after transplantation
Assessed by records from Barretos Cancer Hospital
2 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: MARCELO DE A VIEIRA, MD, Barretos Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2019

Primary Completion (Anticipated)

June 25, 2020

Study Completion (Anticipated)

June 25, 2021

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uterine Transplant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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