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

Uterine Anomaly Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249791
• Other study ID #: Uterine Transplant
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: June 25, 2021

Study information

• Verified date: August 2019
• Source: Barretos Cancer Hospital
• Contact: MARCELO DE A VIEIRA, MD
• Phone: + 55 1733216600
• Email: mvieiraonco[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Uterine Anomaly

Intervention

Procedure:
• Transplantation of the uterus from live donor.
Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Barretos Cancer Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transplant sucess rate	Assessed by records from Barretos Cancer Hospital	2 years after transplantation
Secondary	Live births after uterus transplantion	Assessed by records from Barretos Cancer Hospital	2 years after transplantation
Secondary	Pregnancy rate	Assessed by records from Barretos Cancer Hospital	2 years after transplantation