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Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE) (FSF-TVE)

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ClinicalTrials.gov Identifier: NCT03838302
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

Study Description
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Brief Summary:

The retrieval of tissues removed by laparoscopic surgery larger than trocars caliber, with preservation of the uterus, required for a long time intraperitoneal electromechanical morcellation, until the Food and Drug Administration expressed concern about intraperitoneal dissemination of malignant cells, in the case of unrecognized sarcomas.

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.


Condition or disease Intervention/treatment
Transvaginal Tissue Extraction Procedure: Transvaginal tissue retrieval via a posterior colpotomy Procedure: Transabdominal retrieval via trocar

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Female Sexual Functions With Validated Measurement Scale (Female Sexual Function Index) After Transvaginal Versus Trocars Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
Transvaginal retrieval
Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
 Procedure: 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
 Procedure: Transabdominal retrieval via trocar
Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation


Outcome Measures
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Primary Outcome Measures :
  1. Female Sexual Function Index [ Time Frame: Change from baseline (before surgery) and 2 months after surgery ]

    The Female Sexual Function Index (FSFI) is a brief questionnaire measure of sexual functioning in women.

    Score range: minimum 2.0, maximum 36.0. Higher values represent a better outcome.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing laparoscopic management for myomas or adnexal disease and with specimen retrieval by transvaginal extraction or transbdominal extraction through trocar.
Criteria

Inclusion Criteria:

  • Benign uterine and adnexal pathology
  • Preservation of the uterus
  • Sexually active women
  • Premenopausal women

Exclusion Criteria:

  • Pelvic inflammatory disease, endometriosis and pre-existing dyspareunia or chronic pelvic pain of any origin
  • Previous Hysterectomy
  • Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases, psychopathology, mental and sensory-motor disabilities) comorbidities
  • Language barrier
Contacts and Locations
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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): NCT03838302


Contacts
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Contact: Antonio Simone Laganà, M.D. +393296279579 antoniosimone.lagana@asst-settelaghi.it

Locations
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Italy
"Filippo Del Ponte" Hospital
Varese, Italy, 21100
Contact: Antonio Simone Laganà, M.D.    +393296279579    antoniosimone.lagana@asst-settelaghi.it   
Principal Investigator: Fabio Ghezzi, Prof.         
Principal Investigator: Jvan Casarin, Dr.         
Principal Investigator: Simone Garzon, Dr.         
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Antonio Simone Laganà, M.D. Università degli Studi dell'Insubria
More Information
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Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03838302    
Other Study ID Numbers: FSF-TVE
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Sexual functioning
Laparoscopy
Colpotomy
Specimen retrieval
Transvaginal extraction