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

Primary Purpose

Uterine Anomaly

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transplantation of the uterus from live donor.
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Anomaly focused on measuring uterine transplant, robotic surgery, donor, recipient, uterine anomaly

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Barretos Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uterus Transplantation

Arm Description

Patients undergo transplantation of the uterus from live donor.

Outcomes

Primary Outcome Measures

transplant sucess rate
Assessed by records from Barretos Cancer Hospital

Secondary Outcome Measures

Live births after uterus transplantion
Assessed by records from Barretos Cancer Hospital
Pregnancy rate
Assessed by records from Barretos Cancer Hospital

Full Information

First Posted
January 7, 2020
Last Updated
January 29, 2020
Sponsor
Barretos Cancer Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04249791
Brief Title
Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient.
Acronym
transplant
Official Title
Feasibility Assessment of Assisted Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. Description of the Donor and Recipient Surgical Technique.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
June 25, 2020 (Anticipated)
Study Completion Date
June 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Anomaly
Keywords
uterine transplant, robotic surgery, donor, recipient, uterine anomaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uterus Transplantation
Arm Type
Experimental
Arm Description
Patients undergo transplantation of the uterus from live donor.
Intervention Type
Procedure
Intervention Name(s)
Transplantation of the uterus from live donor.
Intervention Description
Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.
Primary Outcome Measure Information:
Title
transplant sucess rate
Description
Assessed by records from Barretos Cancer Hospital
Time Frame
2 years after transplantation
Secondary Outcome Measure Information:
Title
Live births after uterus transplantion
Description
Assessed by records from Barretos Cancer Hospital
Time Frame
2 years after transplantation
Title
Pregnancy rate
Description
Assessed by records from Barretos Cancer Hospital
Time Frame
2 years after transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARCELO DE A VIEIRA, MD
Phone
+ 55 1733216600
Ext
7130
Email
mvieiraonco@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
MARCELO DE A VIEIRA, MD
Phone
+55 1733216600
Ext
7130
Email
mvieiraonco@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCELO DE A VIEIRA, MD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo A Vieira, MD
Phone
+551733216600
Ext
7130
Email
mvieiraonco@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34487890
Citation
Vieira MA, Souza C, Nobrega L, Reis R, Andrade C, Schmidt R, Carvalho L. Uterine Transplantation with Robot-assisted Uterus Retrieval from Living Donor: First Case in Brazil. J Minim Invasive Gynecol. 2021 Nov;28(11):1817. doi: 10.1016/j.jmig.2021.08.028. Epub 2021 Sep 4.
Results Reference
derived

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

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