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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Transvaginal tissue retrieval via a posterior colpotomy
Procedure/SurgeryTransvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
Transabdominal retrieval via trocar
Procedure/SurgeryTransabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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