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

Not Applicable

• Conditions: Uterine Anomaly
• Interventions: Procedure: Transplantation of the uterus from live donor.

• Registration Number: NCT04249791
• Lead Sponsor: Barretos Cancer Hospital

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.

Study Timeline

• Study Start: 2019-06-25
• Status Verified: 2019-08
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-31
• Last Update Posted: 2020-01-31
• Primary Completion: 2020-06-25
• Study Completion: 2021-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uterus Transplantation	Transplantation of the uterus from live donor.	Patients undergo transplantation of the uterus from live donor.

Primary Outcome Measures

Name	Time	Method
transplant sucess rate	2 years after transplantation	Assessed by records from Barretos Cancer Hospital

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	2 years after transplantation	Assessed by records from Barretos Cancer Hospital
Live births after uterus transplantion	2 years after transplantation	Assessed by records from Barretos Cancer Hospital

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo, Brazil