Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03838302
Acronym
FSF-TVE
Enrollment
40
Registered
2019-02-12
Start date
2023-06-30
Completion date
2027-06-30
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transvaginal Tissue Extraction

Keywords

Sexual functioning, Laparoscopy, Colpotomy, Specimen retrieval, Transvaginal extraction

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.

Interventions

PROCEDURETransvaginal tissue retrieval via a posterior colpotomy

Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation

PROCEDURETransabdominal retrieval via trocar

Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Female Sexual Function IndexChange from baseline (before surgery) and 2 months after surgeryThe 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.

Countries

Italy

Contacts

Primary ContactAntonio Simone Laganà, M.D.
antoniosimone.lagana@asst-settelaghi.it+393296279579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026