Pelvic Organ ProlapseV-PULSENCT05856201
Laparoscopic Sacropexy and Vaginal Natural Orifice Transluminal Endoscopic Surgery Shull Suspension Comparison Trial
A study testing Laparoscopic cervicosacropexy and Shull technique via V-NOTES in people with Pelvic Organ Prolapse, run by Azienda Ospedaliero, Universitaria Pisana.
Trial summary
This is a prospective, randomized multicenter study whose objective is to compare two surgical techniques routinely used at our center for the correction of pelvic organ prolapse (laparoscopic cervicosacropexis versus colposuspension sec. Shull using v-NOTES). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Laparoscopic cervicosacropexy and Shull technique via V-NOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive women referred to one of the participating centers with symptomatic stage 2 or greater (point C≥ -1 pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal) with or without anterior and posterior compartment prolapse will be eligible for inclusion (Criteria for which patients in clinical practice are candidates for one of the two interventions under study)
Who cannot join
- age <18 years, BMI > 30,
- previous hysterectomy,
- inability to comprehend questionnaires, to give informed consent and to return for review,
- unable to undergo general anesthesia,
- prior laparoscopic prolapse repair or vaginal mesh prolapse procedure,
- desire for future pregnancy or current pregnancy diagnosis
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- severe respiratory comorbidity,
- ASA III patients,
- need for concomitant anti-incontinence procedure.
About this study
Official title: Laparoscopic Supracervical Hysterectomy With Cervicosacropexy and Vaginally Assisted NOTES Hysterectomy With Uterosacral Ligament Suspension (Shull Technique): a Randomized Multicentric Prospective Comparison Trial
This is a prospective, randomized multicenter study whose objective is to compare two surgical techniques routinely used at our center for the correction of pelvic organ prolapse (laparoscopic cervicosacropexis versus colposuspension sec. Shull using v-NOTES).
Read the detailed description
patients with pelvic organ prolapse with a stage greater than or equal to stage 2 for the apical compartment who are candidates for surgical correction will be randomized and assigned to one of two treatment groups. The aim is to compare the anatomical, surgical and anesthesiological outcomes between these two surgical techniques, both of which are commonly used in clinical practice for the correction of this type of prolapse.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Laparoscopic cervicosacropexy, Shull technique via V-NOTES
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cervicosacropexyProcedure or surgery
The first step consists of a supracervical hysterectomy with morcellation. Anterior and posterior dissection of the vesicovaginal and rectovaginal space. Placing a flexible blade or a Breisky blade in the vagina which is manipulated by the assistant in order to improve exposure of the tissue planes. The retroperitoneum will then be opened from sacral promontory to cervix with the incision just medial to the uterosacral ligament. A low-weight preshaped Y-shaped polypropylene mesh will be secured to the anterior and posterior vagina with four to six separated absorbable 2.0 polyglactin sutures and two nonabsorbable 2.0 prolene sutures can be placed at the level of the remaining cervix. The mesh will be attached to the sacral promontory using two or three nonabsorbable monofilament 2.0 prolene suture. The retroperitoneal space will be closed with continuous 2.0 polyglactin suture or barbed 2.0 absorbable suture material.
Shull technique via V-NOTESProcedure or surgery
Using a cold-bladed scalpel, pericervical colpotomy and subsequent opening of the Douglas and vesico-uterine space is performed. The following step is forcipressure and section of uterosacral ligaments bilaterally with cold blade scissors and ligation in Polysorb 0. A v-PATH® wall retractor is placed, after insertion of three trocars. Total hysterectomy is then performed by standard V-NOTES technique. After transperitoneal visualization of the ureters bilaterally, the peritoneum is incised between the ureters and the uterosacral ligaments, which are thus bilaterally isolated, and three points in polydioxanone 2/0 are placed per side. The v-PATH wall retractor is then removed. Finally the suspension of the vaginal vault at the uterosacral ligaments is made according to Shull technique. Eventual fascial corrections of concomitant anterior or posterior defects will be associated if needed.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic cervicosacropexy (CSP) | Active comparator | Not described Receives: Procedure: Laparoscopic cervicosacropexy |
| Shull technique via V-NOTES (VNS) | Active comparator | Not described Receives: Procedure: Shull technique via V-NOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
operating time
from skin/vaginal incision to end of skin/vaginal suture
Measured: intraoperative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Measured: at 4 hours post-operative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Measured: at 8 hours post-operative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Measured: at 1 month post-operative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Measured: at 12 hours post-operative
time to mobilization with standing
Time it takes the patient to mobilize to standing independently
Measured: immediately post-operative
hospital stay
hours of post-operative stay
Measured: immediately post-operative
patient satisfaction
assessed by P-QoL (prolapse quality of life) validated questionnaire
Measured: at 6 weeks
patient satisfaction
assessed by P-QoL validated questionnaire
Measured: at 3 months
patient satisfaction
assessed by PGI-I (patient global impression of improvement) validated questionnaires
Measured: at 6 weeks
patient satisfaction
assessed by PGI-I validated questionnaires
Measured: at 3 months
patient satisfaction
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
Measured: at 6 weeks
patient satisfaction
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
Measured: at 3 months
sexual function
assessed by FSFI (female sexual function index) questionnaire
Measured: at 6 weeks
sexual function
assessed by FSFI questionnaire
Measured: at 3 months
sexual function
assessed by TVL (total vaginal lenght) measure
Measured: at 6 weeks
sexual function
assessed by TVL measure
Measured: 3 months
recurrence of prolapse in apical compartment
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
Measured: at 6 weeks and 3 months;
recurrence of prolapse in apical compartment
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
Measured: at 6 weeks
recurrence of prolapse in the anterior and posterior compartments when present
Measured: at 3 months;
postoperative complications
assessed using Clavien-Dindo classification
Measured: from surgery to 3 motnhs follow.up
anesthesiological parameters
End tidal CO2 (carbon dioxide) assessement
Measured: intraoperative
anesthesiological parameters
SpO2 (oxygen saturation) assessement
Measured: intraoperative
anesthesiological parameters
blood pressure assessement (measured in mmHg)
Measured: intraoperative
anesthesiological parameters
intraoperative blood loss assessement (measured in milliliters)
Measured: intraoperative
anesthesiological parameters
degrees of Trendelemburg assessement
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study startMay 2023 (estimated)
- Primary completionSep 2023 (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 Pelvic Organ ProlapseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will perform a interventional, no profit, prospective, randomized 1:1 multicentre, controlled trial with participating tertiary referral hospital centers in Italy, to compare the laparoscopic cervicosacropexy (CSP) and Shull technique via V-NOTES (VNS) in the management of apical prolapse.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Simoncini, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856201
- Sponsor's protocol ID
- V-PULSE study
- Acronym
- V-PULSE
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Supracervical Hysterectomy With Cervicosacropexy and Vaginally Assisted NOTES Hysterectomy With Uterosacral Ligament Suspension (Shull Technique): a Randomized Multicentric Prospective Comparison Trial
- ClinicalTrials.gov ID
- NCT05856201
- Acronym / sponsor ID
- V-PULSE / V-PULSE study
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 May 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.
This is a prospective, randomized multicenter study whose objective is to compare two surgical techniques routinely used at our center for the correction of pelvic organ prolapse (laparoscopic cervicosacropexis versus colposuspension sec. Shull using v-NOTES).
Detailed description
patients with pelvic organ prolapse with a stage greater than or equal to stage 2 for the apical compartment who are candidates for surgical correction will be randomized and assigned to one of two treatment groups. The aim is to compare the anatomical, surgical and anesthesiological outcomes between these two surgical techniques, both of which are commonly used in clinical practice for the correction of this type of prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will perform a interventional, no profit, prospective, randomized 1:1 multicentre, controlled trial with participating tertiary referral hospital centers in Italy, to compare the laparoscopic cervicosacropexy (CSP) and Shull technique via V-NOTES (VNS) in the management of apical prolapse.
| Arm | Type | Receives |
|---|---|---|
| laparoscopic cervicosacropexy (CSP) | Active comparator | Procedure: Laparoscopic cervicosacropexy |
| Shull technique via V-NOTES (VNS) | Active comparator | Procedure: Shull technique via V-NOTES |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive women referred to one of the participating centers with symptomatic stage 2 or greater (point C≥ -1 pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal) with or without anterior and posterior compartment prolapse will be eligible for inclusion (Criteria for which patients in clinical practice are candidates for one of the two interventions under study)
Key exclusion criteria (9 listed)
- age <18 years, BMI > 30,
- previous hysterectomy,
- inability to comprehend questionnaires, to give informed consent and to return for review,
- unable to undergo general anesthesia,
- prior laparoscopic prolapse repair or vaginal mesh prolapse procedure,
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 |
|---|---|---|
| Laparoscopic cervicosacropexyThe first step consists of a supracervical hysterectomy with morcellation. Anterior and posterior dissection of the vesicovaginal and rectovaginal space. Placing a flexible blade or a Breisky blade in the vagina which is manipulated by the assistant in order to improve exposure of the tissue planes. The retroperitoneum will then be opened from sacral promontory to cervix with the incision just medial to the uterosacral ligament. A low-weight preshaped Y-shaped polypropylene mesh will be secured to the anterior and posterior vagina with four to six separated absorbable 2.0 polyglactin sutures and two nonabsorbable 2.0 prolene sutures can be placed at the level of the remaining cervix. The mesh will be attached to the sacral promontory using two or three nonabsorbable monofilament 2.0 prolene suture. The retroperitoneal space will be closed with continuous 2.0 polyglactin suture or barbed 2.0 absorbable suture material. | Procedure or surgery | laparoscopic cervicosacropexy (CSP) |
| Shull technique via V-NOTESUsing a cold-bladed scalpel, pericervical colpotomy and subsequent opening of the Douglas and vesico-uterine space is performed. The following step is forcipressure and section of uterosacral ligaments bilaterally with cold blade scissors and ligation in Polysorb 0. A v-PATH® wall retractor is placed, after insertion of three trocars. Total hysterectomy is then performed by standard V-NOTES technique. After transperitoneal visualization of the ureters bilaterally, the peritoneum is incised between the ureters and the uterosacral ligaments, which are thus bilaterally isolated, and three points in polydioxanone 2/0 are placed per side. The v-PATH wall retractor is then removed. Finally the suspension of the vaginal vault at the uterosacral ligaments is made according to Shull technique. Eventual fascial corrections of concomitant anterior or posterior defects will be associated if needed. | Procedure or surgery | Shull technique via V-NOTES (VNS) |
Primary outcome
operating time
Time frame: intraoperative
from skin/vaginal incision to end of skin/vaginal suture
post-operative pain
Time frame: at 4 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
post-operative pain
Time frame: at 8 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
post-operative pain
Time frame: at 1 month post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
post-operative pain
Time frame: at 12 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
time to mobilization with standing
Time frame: immediately post-operative
Time it takes the patient to mobilize to standing independently
hospital stay
Time frame: immediately post-operative
hours of post-operative stay
patient satisfaction
Time frame: at 6 weeks
assessed by P-QoL (prolapse quality of life) validated questionnaire
patient satisfaction
Time frame: at 3 months
assessed by P-QoL validated questionnaire
patient satisfaction
Time frame: at 6 weeks
assessed by PGI-I (patient global impression of improvement) validated questionnaires
patient satisfaction
Time frame: at 3 months
assessed by PGI-I validated questionnaires
patient satisfaction
Time frame: at 6 weeks
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
patient satisfaction
Time frame: at 3 months
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
sexual function
Time frame: at 6 weeks
assessed by FSFI (female sexual function index) questionnaire
sexual function
Time frame: at 3 months
assessed by FSFI questionnaire
sexual function
Time frame: at 6 weeks
assessed by TVL (total vaginal lenght) measure
sexual function
Time frame: 3 months
assessed by TVL measure
recurrence of prolapse in apical compartment
Time frame: at 6 weeks and 3 months;
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
recurrence of prolapse in apical compartment
Time frame: at 6 weeks
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
recurrence of prolapse in the anterior and posterior compartments when present
Time frame: at 3 months;
postoperative complications
Time frame: from surgery to 3 motnhs follow.up
assessed using Clavien-Dindo classification
anesthesiological parameters
Time frame: intraoperative
End tidal CO2 (carbon dioxide) assessement
anesthesiological parameters
Time frame: intraoperative
SpO2 (oxygen saturation) assessement
anesthesiological parameters
Time frame: intraoperative
blood pressure assessement (measured in mmHg)
anesthesiological parameters
Time frame: intraoperative
intraoperative blood loss assessement (measured in milliliters)
anesthesiological parameters
Time frame: intraoperative
degrees of Trendelemburg assessement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cervicosacropexy and Shull technique via V-NOTES in people with Pelvic Organ Prolapse, run by Azienda Ospedaliero, Universitaria Pisana.
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 9 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 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operating time (time frame: intraoperative). The study lists 26 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 May 2023.