Laparoscopic Sacropexy and Vaginal Natural Orifice Transluminal Endoscopic Surgery Shull Suspension Comparison Trial (V-PULSE)

May 3, 2023 updated by: Tommaso Simoncini, Azienda Ospedaliero, Universitaria Pisana

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • severe respiratory comorbidity,
  • ASA III patients,
  • need for concomitant anti-incontinence procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: laparoscopic cervicosacropexy (CSP)
Procedure: Laparoscopic cervicosacropexy
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.
Active Comparator: Shull technique via V-NOTES (VNS)
Procedure: Shull technique via V-NOTES
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
operating time
Time Frame: intraoperative
from skin/vaginal incision to end of skin/vaginal suture
intraoperative
post-operative pain
Time Frame: at 4 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
at 4 hours post-operative
post-operative pain
Time Frame: at 8 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
at 8 hours post-operative
post-operative pain
Time Frame: at 1 month post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
at 1 month post-operative
post-operative pain
Time Frame: at 12 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
at 12 hours post-operative
time to mobilization with standing
Time Frame: immediately post-operative
Time it takes the patient to mobilize to standing independently
immediately post-operative
hospital stay
Time Frame: immediately post-operative
hours of post-operative stay
immediately post-operative
patient satisfaction
Time Frame: at 6 weeks
assessed by P-QoL (prolapse quality of life) validated questionnaire
at 6 weeks
patient satisfaction
Time Frame: at 3 months
assessed by P-QoL validated questionnaire
at 3 months
patient satisfaction
Time Frame: at 6 weeks
assessed by PGI-I (patient global impression of improvement) validated questionnaires
at 6 weeks
patient satisfaction
Time Frame: at 3 months
assessed by PGI-I validated questionnaires
at 3 months
patient satisfaction
Time Frame: at 6 weeks
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
at 6 weeks
patient satisfaction
Time Frame: at 3 months
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
at 3 months
sexual function
Time Frame: at 6 weeks
assessed by FSFI (female sexual function index) questionnaire
at 6 weeks
sexual function
Time Frame: at 3 months
assessed by FSFI questionnaire
at 3 months
sexual function
Time Frame: at 6 weeks
assessed by TVL (total vaginal lenght) measure
at 6 weeks
sexual function
Time Frame: 3 months
assessed by TVL measure
3 months
recurrence of prolapse in apical compartment
Time Frame: at 6 weeks and 3 months;
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
at 6 weeks and 3 months;
recurrence of prolapse in apical compartment
Time Frame: at 6 weeks
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
at 6 weeks
recurrence of prolapse in the anterior and posterior compartments when present
Time Frame: at 3 months;
at 3 months;
postoperative complications
Time Frame: from surgery to 3 motnhs follow.up
assessed using Clavien-Dindo classification
from surgery to 3 motnhs follow.up
anesthesiological parameters
Time Frame: intraoperative
End tidal CO2 (carbon dioxide) assessement
intraoperative
anesthesiological parameters
Time Frame: intraoperative
SpO2 (oxygen saturation) assessement
intraoperative
anesthesiological parameters
Time Frame: intraoperative
blood pressure assessement (measured in mmHg)
intraoperative
anesthesiological parameters
Time Frame: intraoperative
intraoperative blood loss assessement (measured in milliliters)
intraoperative
anesthesiological parameters
Time Frame: intraoperative
degrees of Trendelemburg assessement
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliero, Universitaria Pisana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V-PULSE study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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