Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT03838302

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

"Filippo Del Ponte" Hospital

Varese, 21100, Italy

Location contact

Antonio Simone Laganà, M.D.

CONTACT

[email protected]

+393296279579

Fabio Ghezzi, Prof.

PRINCIPAL_INVESTIGATOR

Jvan Casarin, Dr.

PRINCIPAL_INVESTIGATOR

Simone Garzon, Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal tissue retrieval via a posterior colpotomy

Procedure

Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation

Transabdominal retrieval via trocar

Procedure

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

Primary outcomes

  1. Female Sexual Function Index

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Simone Laganà, M.D.

CONTACT

[email protected]

+393296279579

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study 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

Acronym: FSF-TVE

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 12, 2019
Registry last updated
Apr 29, 2021

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.