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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorUniversità degli Studi dell'Insubria

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Benign uterine and adnexal pathology

Preservation of the uterus

Sexually active women

Premenopausal women

Disqualifiers

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 population

Women undergoing laparoscopic management for myomas or adnexal disease and with specimen retrieval by transvaginal extraction or transbdominal extraction through trocar.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Transvaginal tissue retrieval via a posterior colpotomy

    Procedure/Surgery

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

  • Transabdominal retrieval via trocar

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Transvaginal retrieval1 intervention
Group B: Transabdominal retrieval1 intervention

Trial outcomes

Primary outcomes

1

Female Sexual Function Index

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.

Time frame
Change from baseline (before surgery) and 2 months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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