Uterine Anomaly
Conditions
Keywords
uterine transplant, robotic surgery, donor, recipient, uterine anomaly
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.
Interventions
PROCEDURETransplantation of the uterus from live donor.
Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Barretos Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| transplant sucess rate | 2 years after transplantation | Assessed by records from Barretos Cancer Hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live births after uterus transplantion | 2 years after transplantation | Assessed by records from Barretos Cancer Hospital |
| Pregnancy rate | 2 years after transplantation | Assessed by records from Barretos Cancer Hospital |
Countries
Brazil
Contacts
Primary ContactMARCELO DE A VIEIRA, MD
Backup ContactMARCELO DE A VIEIRA, MD
Outcome results
None listed