"Filippo Del Ponte" Hospital
Varese, 21100, Italy
Location contact
Antonio Simone Laganà, M.D.
CONTACT
Fabio Ghezzi, Prof.
PRINCIPAL_INVESTIGATOR
Jvan Casarin, Dr.
PRINCIPAL_INVESTIGATOR
Simone Garzon, Dr.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT03838302
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.
Trial opening soon.
Get Notified18 year–50 year
Female
Observational
Varese, 21100, Italy
Antonio Simone Laganà, M.D.
CONTACT
Fabio Ghezzi, Prof.
PRINCIPAL_INVESTIGATOR
Jvan Casarin, Dr.
PRINCIPAL_INVESTIGATOR
Simone Garzon, Dr.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Università degli Studi dell'Insubria
Other
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
Acronym: FSF-TVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.