Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT03838302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-04-29
First Post:
2019-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)
Sponsor:
Università degli Studi dell'Insubria
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FSF-TVE
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: