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

Università degli Studi dell'Insubria

Status: Not yet enrolling

Conditions: Transvaginal Tissue Extraction

Treatments: Procedure: Transvaginal tissue retrieval via a posterior colpotomy; Procedure: Transabdominal retrieval via trocar

Study type: Observational

Funder types: Other

Identifiers

NCT03838302

FSF-TVE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Transvaginal retrieval

Description:

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

Treatment:

Procedure: Transvaginal tissue retrieval via a posterior colpotomy

Transabdominal retrieval

Description:

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

Treatment:

Procedure: Transabdominal retrieval via trocar