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Uterine Transposition: Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040921
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Reitan Ribeiro, Hospital Erasto Gaertner

Brief Summary:
This prospective nonrandomized multicenter phase I study, will evaluate the feasibility of performing uterine transposition before chemoradiation for rectal cancer and uterine reimplantation after the treatment.

Condition or disease Intervention/treatment Phase
Postoperative Complications Intraoperative Complications Tissue Damage Ovarian Failure Uterus Disorder Procedure: Uterine transposition. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Recruitment completed. Final data collection in April/2020.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Uterine Transposition: Feasibility Study
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 1, 2019
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: Uterine Transposition
Patients submitted to uterine transposition.
Procedure: Uterine transposition.
Surgical transposition of the uterus to the upper abdomen. After the end of radiotherapy, rectosigmoidectomy is performed and the uterus is repositioned into the pelvis.




Primary Outcome Measures :
  1. Uterine preservation after transposition to the upper abdomen and replacement in the pelvis [ Time Frame: 6 months ]
    The preservation of the uterus with normal endometrium confirmed by ultra-sound, after the surgery to place it in the upper abdomen and after replacing the uterus back to its normal position.


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 6 months ]
    Intraoperative and postoperative complications

  2. Cancer recurrence [ Time Frame: Through study completion, an average of 2 years ]
    Local and distant recurrences



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with pelvic cancer and indication for pelvic radiation therapy who have fertility sparing desire.

Exclusion Criteria:

  • Previously documented infertility, ovarian failure or gynecologic cancer.
  • More than 40 yo.
  • Previous oophorectomy
  • Tumor infiltrating uterus or adnexes
  • Presence of peritoneal metastasis
  • Presence of systemic metastasis
  • Previous retroperitoneal radiotherapy
  • Retroperitoneal radiotherapy planned

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040921


Locations
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Brazil
Erasto Gaertner Hospital
Curitiba, Parana, Brazil, 81.520-060
Sponsors and Collaborators
Hospital Erasto Gaertner
Investigators
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Principal Investigator: Reitan Ribeiro, MD Erasto Gaertner Hospital
Additional Information:
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Responsible Party: Reitan Ribeiro, MD, Hospital Erasto Gaertner
ClinicalTrials.gov Identifier: NCT03040921    
Other Study ID Numbers: HEG01
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Hospital Ethics Committee did not approve individual participant data sharing. Recruitment completed. Final data collection in April/2020.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Intraoperative Complications
Pathologic Processes