Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)
NCT ID: NCT03838302
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2023-06-30
2027-06-30
Brief Summary
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Transvaginal contained tissue extraction via a posterior colpotomy and manual morcellation in the bag is one of the possible alternatives.
Available data suggested the effectiveness and safety of this technique, also in terms of time and costs, without a increased risk intra and post-operative complications.
The available evidence shows the lack of sequelae also on fertility and sexual function.
Nevertheless, sexual function has never been evaluated qualitatively in all its aspects nor quantitatively with a validated measurement scale, which can allow us to inform the consequences on the real risk of implications on sexual function determined by vaginal incision. In view of these elements, the aim of the investigator's study is to compare patients in whom laparoscopic tissue removal has been carried out with posterior colpotomy or without it with removal from the trocars.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Transvaginal retrieval
Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
Transvaginal tissue retrieval via a posterior colpotomy
Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
Transabdominal retrieval
Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
Transabdominal retrieval via trocar
Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
Interventions
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Transvaginal tissue retrieval via a posterior colpotomy
Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
Transabdominal retrieval via trocar
Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
Eligibility Criteria
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Inclusion Criteria
* Preservation of the uterus
* Sexually active women
* Premenopausal women
Exclusion Criteria
* Previous Hysterectomy
* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases, psychopathology, mental and sensory-motor disabilities) comorbidities
* Language barrier
18 Years
50 Years
FEMALE
No
Sponsors
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Università degli Studi dell'Insubria
OTHER
Responsible Party
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Antonio Simone Laganà
Principal Investigator
Principal Investigators
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Antonio Simone Laganà, M.D.
Role: PRINCIPAL_INVESTIGATOR
Università degli Studi dell'Insubria
Locations
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"Filippo Del Ponte" Hospital
Varese, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FSF-TVE
Identifier Type: -
Identifier Source: org_study_id
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