Pelvic Organ ProlapseNCT06220253
Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy
A study testing vaginal hysterectomy by bipolar vessels sealing and vaginal hysterectomy by traditional technique in people with Pelvic Organ Prolapse and Gynecologic Disorders, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures. 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
- Pelvic Organ Prolapse, Gynecologic Disorders, Surgery
- What is being tested?
- vaginal hysterectomy by bipolar vessels sealing and vaginal hysterectomy by traditional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2024to Mar 2025
- Phase
- Interventional
- 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
Who may be able to join
- Women aged >18 years
- Genital prolapse > II degree in accordance with the "POP-Q System" eligible for vaginal hysterectomy
- Understanding and signing of informed consent for surgical procedure
Who cannot join
- Need for simultaneous bilateral adnexectomy
- Previous cesarian section
- Patients with abdominal laparoscopic or laparotomy history
- Patients with malignant pathology and/or adnexal pathology
- Confirmed or presumed pregnancy
Trial locations and contacts
1 site in 1 country.
Stefano Salvatore, MD contact
Italy1 site
Arianna Casiraghi
Milan, 20159
Arianna Casiraghi, MD, 3482400195
stefano salvatore, PhD
About this study
Official title: Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy: Traditional Versus Minimally Invasive Bipolar Coagulation Technique
Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.
Read the detailed description
This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics.
Patients will be randomized 1:1 in two groups:
- Study group: bipolar coagulation technique
- Comparison group: reabsorbable stitches The primary outcome of the study is to compare the learning curves for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women.
Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration.
The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.
- Conditions
- Pelvic Organ Prolapse, Gynecologic Disorders, Surgery
- Being tested
- vaginal hysterectomy by bipolar vessels sealing, vaginal hysterectomy by traditional technique
- Keywords
- pelvic organ prolapse, urogynecologic surgery, learning curve, bipolar vessels sealing
- Medical subject headings
- Pelvic Organ Prolapse, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal hysterectomy by bipolar vessels sealingProcedure or surgery
The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be coagulated and cut by a bipolar vessel sealing instrument
vaginal hysterectomy by traditional techniqueProcedure or surgery
The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Hysterectomy by bipolar coagulation technique | Other | The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the portio, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking, section and ligament of the ligaments uterus-sacral ligaments, and subsequent coagulation by bipolar instrument of the other structures of the uterus and their section, in particular of the uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally. Receives: Procedure: vaginal hysterectomy by bipolar vessels sealing |
| Vaginal hysterectomy by traditional technique with reabsorbable stitches | Other | The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the port, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking and suturing with absorbable threads of all the support structures of the uterus, in particular uterus-sacral ligaments, uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally. Receives: Procedure: vaginal hysterectomy by traditional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning curve comparison
The primary objective of the study is to compare the learning curves (in terms of operating time, blood loss, intraoperative complications) for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. The two procedures compared will be the traditional technique performed by applying reabsorbable sutures and the bipolar coagulation technique.
Measured: immediate post operative time
Secondary outcomes (1)
Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.
Effectiveness will be assessed in terms of short-term outcomes such as:
Intraoperative complications post-operative pain inpatient time Post-operative urinary infections vaginal infections, postoperative collected hematomas
Measured: 3 days after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study startJun 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 in two groups: 1. Study group: bipolar coagulation technique 2. Comparison group: reabsorbable stitches
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
- Investigators
- Stefano Salvatore, MD, Principal investigator, San Raffaele Hospital, Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220253
- Sponsor's protocol ID
- LEACURV
- Status last verified
- May 2024
- First submitted
- 6 Jun 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy: Traditional Versus Minimally Invasive Bipolar Coagulation Technique
- ClinicalTrials.gov ID
- NCT06220253
- Acronym / sponsor ID
- LEACURV
- Conditions
- Pelvic Organ Prolapse, Gynecologic Disorders, Surgery
- Keywords
- pelvic organ prolapse, urogynecologic surgery, learning curve, bipolar vessels sealing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 23 Jan 2024 (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.
Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.
Detailed description
This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics.
Patients will be randomized 1:1 in two groups:
- Study group: bipolar coagulation technique
- Comparison group: reabsorbable stitches The primary outcome of the study is to compare the learning curves for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women.
Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration.
The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 in two groups: 1. Study group: bipolar coagulation technique 2. Comparison group: reabsorbable stitches
| Arm | Type | Receives |
|---|---|---|
| Vaginal Hysterectomy by bipolar coagulation technique | Other | Procedure: vaginal hysterectomy by bipolar vessels sealingThe surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the portio, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking, section and ligament of the ligaments uterus-sacral ligaments, and subsequent coagulation by bipolar instrument of the other structures of the uterus and their section, in particular of the uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally. |
| Vaginal hysterectomy by traditional technique with reabsorbable stitches | Other | Procedure: vaginal hysterectomy by traditional techniqueThe surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the port, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking and suturing with absorbable threads of all the support structures of the uterus, in particular uterus-sacral ligaments, uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged >18 years
- Genital prolapse > II degree in accordance with the "POP-Q System" eligible for vaginal hysterectomy
- Understanding and signing of informed consent for surgical procedure
Key exclusion criteria (5 listed)
- Need for simultaneous bilateral adnexectomy
- Previous cesarian section
- Patients with abdominal laparoscopic or laparotomy history
- Patients with malignant pathology and/or adnexal pathology
- Confirmed or presumed pregnancy
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 |
|---|---|---|
| vaginal hysterectomy by bipolar vessels sealingThe surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be coagulated and cut by a bipolar vessel sealing instrument | Procedure or surgery | Vaginal Hysterectomy by bipolar coagulation technique |
| vaginal hysterectomy by traditional techniqueThe surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads | Procedure or surgery | Vaginal hysterectomy by traditional technique with reabsorbable stitches |
Primary outcome
Learning curve comparison
Time frame: immediate post operative time
The primary objective of the study is to compare the learning curves (in terms of operating time, blood loss, intraoperative complications) for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. The two procedures compared will be the traditional technique performed by applying reabsorbable sutures and the bipolar coagulation technique.
1 secondary outcome
Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.
Time frame: 3 days after the surgical procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Stefano Salvatore, MD contact
Stefano Salvatore, MD principal investigator
San Raffaele Hospital, Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal hysterectomy by bipolar vessels sealing and vaginal hysterectomy by traditional technique in people with Pelvic Organ Prolapse and Gynecologic Disorders, run by IRCCS San Raffaele 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 3 inclusion and 5 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 21 May 2024. 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?
Contact Arianna Casiraghi, MD (3482400195, casiraghi.arianna@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning curve comparison (time frame: immediate post operative time). 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 21 May 2024.