HysterectomyLAST-1NCT05421156
Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy
An observational study of Hysterectomy, run by University of Palermo.
Trial summary
Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Subtotal Laparoscopic Hysterectomy and Total Laparoscopic Hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2028
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions
Who may be able to join
- Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.
Who cannot join
- Women with gynecological and non-gynecological cancers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions
Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.
- Conditions
- Hysterectomy
- Being tested
- Subtotal Laparoscopic Hysterectomy, Total Laparoscopic Hysterectomy
- Keywords
- Subtotal Laparoscopic Hysterectomy, Total Laparoscopic Hysterectomy, Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtotal Laparoscopic HysterectomyProcedure or surgery
Subtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy.
Total Laparoscopic HysterectomyProcedure or surgery
Total laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Subtotal Laparoscopic Hysterectomy | Women who underwent subtotal laparoscopic hysterectomy Receives: Procedure: Subtotal Laparoscopic Hysterectomy | |
| Total Laparoscopic Hysterectomy | Women who underwent total laparoscopic hysterectomy Receives: Procedure: Total Laparoscopic Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Dysfunctions
Female Sexual Function Index
Measured: 5 years after surgery
Secondary outcomes (2)
Urinary Dysfunctions
Pelvic Floor Distress Inventory short form
Measured: 5 years after surgery
Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP-Q) evaluation
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study startJul 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, University of Palermo
- Investigators
- Antonio Simone Laganà, M.D., Ph.D., Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421156
- Sponsor's protocol ID
- LAST-1
- Acronym
- LAST-1
- Status last verified
- Oct 2022
- First submitted
- 12 Jun 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions
- ClinicalTrials.gov ID
- NCT05421156
- Acronym / sponsor ID
- LAST-1 / LAST-1
- Conditions
- Hysterectomy
- Keywords
- Subtotal Laparoscopic Hysterectomy, Total Laparoscopic Hysterectomy, Hysterectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 16 Jun 2022 (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.
Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subtotal Laparoscopic Hysterectomy | – | Procedure: Subtotal Laparoscopic HysterectomyWomen who underwent subtotal laparoscopic hysterectomy |
| Total Laparoscopic Hysterectomy | – | Procedure: Total Laparoscopic HysterectomyWomen who underwent total laparoscopic hysterectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions
Key inclusion criteria (1 listed)
- Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.
Key exclusion criteria (1 listed)
- Women with gynecological and non-gynecological cancers.
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 |
|---|---|---|
| Subtotal Laparoscopic HysterectomySubtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy. | Procedure or surgery | Subtotal Laparoscopic Hysterectomy |
| Total Laparoscopic HysterectomyTotal laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy | Procedure or surgery | Total Laparoscopic Hysterectomy |
Primary outcome
Sexual Dysfunctions
Time frame: 5 years after surgery
Female Sexual Function Index
2 secondary outcomes
Urinary Dysfunctions
Time frame: 5 years after surgery
Pelvic Organ Prolapse
Time frame: 5 years after surgery
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 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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., Ph.D. principal investigator
University of Palermo
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by University of Palermo.
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 1 inclusion and 1 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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., Ph.D. (3296279579, antoniosimone.lagana@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Dysfunctions (time frame: 5 years 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 2 Nov 2022.