HysterectomyNCT05681910
Mode of Uterine Extraction in Total Laparoscopic Hysterectomy
An observational study of Hysterectomy, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Hysterectomy remains the most common major gynecological operation worldwide. It may be carried out by three different routes and its variations: vaginal, abdominal, and laparoscopic. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinical data of patients undergoing total laparoscopic hysterectomies for larger uteri with uterus size of 12 gestational weeks (g.w.) or greater between. Inclusion criteria were as follows: (1) patients with uterine myomas or endometrioma; (2) patients who have good physical conditions and have no reproduction requirement; (3) patients with uterine size ≥ 12 weeks of gestation; and (4) patients who receive no hormone therapy in the recent 3 months. Exclusion criteria were as follows: (1) patients who are contraindicated to laparoscopic surgery; (2) patients with uterus size >16 g.w.; (3) patients with cervical myoma; (4) patients with uterine myoma associated with ovarian lesions; (5) patients with suspicious malignant gynecological disease diagnosed by ultrasound or MRI; and (6) patients with cervical cancer diagnosed by Thinprip cytologic test (TCT) and malignant endometrial lesions diagnosed by diagnostic curettage
Who may be able to join
- patients undergoing total laparoscopic hysterectomies for larger uteri
Who cannot join
- oncology
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
Ferrara
Gennaro Scutiero, MD, +390532236576, gennaro.scutiero@unife.it
About this study
Official title: Predictive Factors for Mode of Extraction of the Uterus in Total Laparoscopic Hysterectomy
Hysterectomy remains the most common major gynecological operation worldwide. It may be carried out by three different routes and its variations: vaginal, abdominal, and laparoscopic.
A large uterus will lead to several surgical difficulties during laparoscopic hysterectomy, such as limited operative field, restrictive instrument range of motion, and difficult removal of the specimen.
The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or uterine morcellation approaches after strict preoperative assessment.
- Conditions
- Hysterectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative complications
mean operation time, uterus removal time, blood loss
Measured: During surgery
Post operative complications
Pelvic hematoma, vaginal stump infection, lower limb venous thrombosis
Measured: 30 days 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 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionDec 2024 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Scutiero, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681910
- Sponsor's protocol ID
- 879/2022/Oss/AOUFe
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Mode of Extraction of the Uterus in Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT05681910
- Acronym / sponsor ID
- 879/2022/Oss/AOUFe
- Conditions
- Hysterectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jan 2023 (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 remains the most common major gynecological operation worldwide. It may be carried out by three different routes and its variations: vaginal, abdominal, and laparoscopic.
A large uterus will lead to several surgical difficulties during laparoscopic hysterectomy, such as limited operative field, restrictive instrument range of motion, and difficult removal of the specimen.
The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or uterine morcellation approaches after strict preoperative assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical data of patients undergoing total laparoscopic hysterectomies for larger uteri with uterus size of 12 gestational weeks (g.w.) or greater between. Inclusion criteria were as follows: (1) patients with uterine myomas or endometrioma; (2) patients who have good physical conditions and have no reproduction requirement; (3) patients with uterine size ≥ 12 weeks of gestation; and (4) patients who receive no hormone therapy in the recent 3 months. Exclusion criteria were as follows: (1) patients who are contraindicated to laparoscopic surgery; (2) patients with uterus size >16 g.w.; (3) patients with cervical myoma; (4) patients with uterine myoma associated with ovarian lesions; (5) patients with suspicious malignant gynecological disease diagnosed by ultrasound or MRI; and (6) patients with cervical cancer diagnosed by Thinprip cytologic test (TCT) and malignant endometrial lesions diagnosed by diagnostic curettage
Key inclusion criteria (1 listed)
- patients undergoing total laparoscopic hysterectomies for larger uteri
Key exclusion criteria (1 listed)
- oncology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative complications
Time frame: During surgery
mean operation time, uterus removal time, blood loss
Post operative complications
Time frame: 30 days after surgery
Pelvic hematoma, vaginal stump infection, lower limb venous thrombosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
Ferrara, Italy
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 Hysterectomy, run by Università degli Studi di Ferrara 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 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative complications (time frame: During surgery). The study lists 2 primary outcomes in all. 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 12 Jan 2023.