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

April 28, 2021 updated by: Antonio Simone Laganà, Università degli Studi dell'Insubria

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy, 21100
        • "Filippo Del Ponte" Hospital
        • Principal Investigator:
          • Fabio Ghezzi, Prof.
        • Principal Investigator:
          • Jvan Casarin, Dr.
        • Principal Investigator:
          • Simone Garzon, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (before surgery) and 2 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

February 9, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FSF-TVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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