Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT04250766
Brief Summary:
This is a prospective multi-center interventional study that will be performed in an effort to assess the diagnostic accuracy performance of preoperative vaginal ultrasound-guided biopsy (VUGB) to detect the exact histology of uterine tumors and thereafter triage cases being eligible for morcellation during laparoscopic resection. Ten tertiary French centers will participate in the present study.
Detailed Description:
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
During the inclusion check-up, exams must be performed within 30 days before the guided echo biopsy: clinical examination, gynecological examination, pain assessment (visual or verbal scale), biological and radiological assessment (Doppler ultrasound Pelvis and MRI pelvis).
The echo-guided biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).
Between the biopsy and the procedure, the patient will be reviewed by the investigating surgeon to check the outcome of the biopsy, any pain or complications of the biopsy.
The surgical procedure will be performed by laparotomy and will consist of an extra-facial hysterectomy without fragmentation of the surgical specimen (extraction technique "in block"). During the procedure, the investigating surgeon will perform a description of the abdominal and pelvic cavity and perform a block excision of the tumor.
At one month of the surgery, patient will be reviewed by the investigating surgeon for a postoperative visit with clinical examination, gynecological and histopathological results.
Thereafter, the follow-up of the patients will be carried out according to the standards of care according to the histopathological results.
Study:
NCT04250766
Study Brief:
Protocol Section:
NCT04250766