NCT03838302

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
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transvaginal Tissue Extraction

Interventions

Type	Name	Description
PROCEDURE	Transvaginal tissue retrieval via a posterior colpotomy	Transvaginal retrieval via a posterior colpotomy 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

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-06-01
• Completion: 2027-06-01
• First posted: 2019-02-12
• Last updated: 2021-04-29

Locations

1 site across 1 country: Italy