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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Assessment of Assisted Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. Description of the Donor and Recipient Surgical Technique.

Conditions
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Uterine Anomaly

Intervention / Treatment
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* Procedure: Transplantation of the uterus from live donor.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterus Transplantation<br>Patients undergo transplantation of the uterus from live donor. | Procedure: Transplantation of the uterus from live donor.<br>* Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transplant sucess rate | Assessed by records from Barretos Cancer Hospital | 2 years after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live births after uterus transplantion | Assessed by records from Barretos Cancer Hospital | 2 years after transplantation | 
| Pregnancy rate | Assessed by records from Barretos Cancer Hospital | 2 years after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterine transplant, robotic surgery, donor, recipient, uterine anomaly