Transvaginal Tissue ExtractionFSF-TVENCT03838302
Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)
An observational study of Transvaginal Tissue Extraction, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Transvaginal Tissue Extraction
- What is being tested?
- Transvaginal tissue retrieval via a posterior colpotomy and Transabdominal retrieval via trocar
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing laparoscopic management for myomas or adnexal disease and with specimen retrieval by transvaginal extraction or transbdominal extraction through trocar.
Who may be able to join
- Benign uterine and adnexal pathology
- Preservation of the uterus
- Sexually active women
- Premenopausal women
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
"Filippo Del Ponte" Hospital
Varese, 21100
Antonio Simone Laganà, M.D., +393296279579, antoniosimone.lagana@asst-settelaghi.it
Fabio Ghezzi, Prof.
About this study
Official 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
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.
Read more
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.
- Conditions
- Transvaginal Tissue Extraction
- Being tested
- Transvaginal tissue retrieval via a posterior colpotomy, Transabdominal retrieval via trocar
- Keywords
- Sexual functioning, Laparoscopy, Colpotomy, Specimen retrieval, Transvaginal extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal tissue retrieval via a posterior colpotomyProcedure or surgery
Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
Transabdominal retrieval via trocarProcedure or surgery
Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal retrieval | Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation Receives: Procedure: Transvaginal tissue retrieval via a posterior colpotomy | |
| Transabdominal retrieval | Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation Receives: Procedure: Transabdominal retrieval via trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (before surgery) and 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study startJun 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transvaginal Tissue ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838302
- Sponsor's protocol ID
- FSF-TVE
- Acronym
- FSF-TVE
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03838302
- Acronym / sponsor ID
- FSF-TVE / FSF-TVE
- Conditions
- Transvaginal Tissue Extraction
- Keywords
- Sexual functioning, Laparoscopy, Colpotomy, Specimen retrieval, Transvaginal extraction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal retrieval | – | Procedure: Transvaginal tissue retrieval via a posterior colpotomyTransvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation |
| Transabdominal retrieval | – | Procedure: Transabdominal retrieval via trocarTransabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing laparoscopic management for myomas or adnexal disease and with specimen retrieval by transvaginal extraction or transbdominal extraction through trocar.
Key inclusion criteria (4 listed)
- Benign uterine and adnexal pathology
- Preservation of the uterus
- Sexually active women
- Premenopausal women
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal tissue retrieval via a posterior colpotomyTransvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation | Procedure or surgery | Transvaginal retrieval |
| Transabdominal retrieval via trocarTransabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation | Procedure or surgery | Transabdominal retrieval |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Transvaginal Tissue Extraction
Active, not recruitingObservational study
Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
Uterine Fibroids, Adenomyosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Simone Laganà, M.D. principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transvaginal Tissue Extraction, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Simone Laganà, M.D. (+393296279579, antoniosimone.lagana@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (time frame: Change from baseline (before surgery) and 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.