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

Not yet recruiting

• Conditions: Transvaginal Tissue Extraction
• Interventions: Procedure: Transabdominal retrieval via trocar; Procedure: Transvaginal tissue retrieval via a posterior colpotomy

• Registration Number: NCT03838302
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-09
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29
• Study Start: 2023-06
• Primary Completion: 2025-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transabdominal retrieval	Transabdominal retrieval via trocar	Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
Transvaginal retrieval	Transvaginal tissue retrieval via a posterior colpotomy	Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index	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.

Trial Locations

Locations (1)

"Filippo Del Ponte" Hospital; 🇮🇹 Varese, Italy