Uterine Transposition: Feasibility Study

NCT03040921 | Completed DMC

• 1 other identifier: HEG01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Intraoperative Complications; Tissue Damage; Ovarian Failure; Uterus Disorder

Outcome Measures

Primary Outcomes (1)

• Uterine preservation after transposition to the upper abdomen and replacement in the pelvis

  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.

  6 months

Secondary Outcomes (2)

• Morbidity

  6 months

• Cancer recurrence

  Through study completion, an average of 2 years

Study Arms (1)

Uterine Transposition

EXPERIMENTAL

Patients submitted to uterine transposition.

Procedure: Uterine transposition.

Interventions

Uterine transposition. PROCEDURE

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.

Uterine Transposition

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Erasto Gaertner: lead

Study Sites (1)

Erasto Gaertner Hospital

Curitiba, Paraná, 81.520-060, Brazil

Location

Related Links

• Erasto Gaertner Hospital webpage

MeSH Terms

Conditions

Postoperative Complications; Intraoperative Complications; Uterine Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Reitan Ribeiro, MD

  Erasto Gaertner Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Recruitment completed. Final data collection in April/2020.

Study Record Dates

• First Submitted: January 14, 2017
• First Posted: February 2, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: April 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)