MedDataX Logo

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

NCT ID: NCT04249791

Last Updated: 2020-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-25

Study Completion Date

2021-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Anomaly

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

uterine transplant robotic surgery donor recipient uterine anomaly

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Uterus Transplantation

Patients undergo transplantation of the uterus from live donor.

Group Type EXPERIMENTAL

Transplantation of the uterus from live donor.

Intervention Type PROCEDURE

Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transplantation of the uterus from live donor.

Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Barretos Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MARCELO DE A VIEIRA, MD

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barretos Cancer Hospital

Barretos, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

MARCELO DE A VIEIRA, MD

Role: CONTACT

Phone: + 55 1733216600

Email: [email protected]

MARCELO DE A VIEIRA, MD

Role: CONTACT

Phone: +55 1733216600

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marcelo A Vieira, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Vieira MA, Souza C, Nobrega L, Reis R, Andrade C, Schmidt R, Carvalho L. Uterine Transplantation with Robot-assisted Uterus Retrieval from Living Donor: First Case in Brazil. J Minim Invasive Gynecol. 2021 Nov;28(11):1817. doi: 10.1016/j.jmig.2021.08.028. Epub 2021 Sep 4.

Reference Type DERIVED
PMID: 34487890 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Uterine Transplant

Identifier Type: -

Identifier Source: org_study_id