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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Transvaginal Tissue Extraction

Intervention / Treatment
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* Procedure: Transvaginal tissue retrieval via a posterior colpotomy
* Procedure: Transabdominal retrieval via trocar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transvaginal retrieval<br>Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation | Procedure: Transvaginal tissue retrieval via a posterior colpotomy<br>* Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation<br>|
| Transabdominal retrieval<br>Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation | Procedure: Transabdominal retrieval via trocar<br>* Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline (before surgery) and 2 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual functioning, Laparoscopy, Colpotomy, Specimen retrieval, Transvaginal extraction