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

Transvaginal Tissue Extraction Clinical Trial

— FSF-TVE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03838302
• Other study ID #: FSF-TVE
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: June 2027

Study information

• Verified date: April 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: +393296279579
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Transvaginal Tissue Extraction

Intervention

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

Locations

Country	Name	City	State
Italy	"Filippo Del Ponte" Hospital	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual Function Index	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