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

B

Barretos Cancer Hospital

Status

Unknown

Conditions

Uterine Anomaly

Treatments

Procedure: Transplantation of the uterus from live donor.

Study type

Interventional

Funder types

Other

Identifiers

NCT04249791
Uterine Transplant

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Uterus Transplantation
Experimental group
Description:
Patients undergo transplantation of the uterus from live donor.
Treatment:
Procedure: Transplantation of the uterus from live donor.

Trial contacts and locations

1

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Central trial contact

MARCELO DE A VIEIRA, MD; MARCELO DE A VIEIRA, MD

Data sourced from clinicaltrials.gov

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