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Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lateral suspension via V-NOTES surgery
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, lateral suspension, v-notes, pop-q, pısq-12

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with more than 2nd and 3rd degree uterine prolapsus
  • Patients with more than 2nd and 3rd degree cystocele

Exclusion Criteria:

  • Having endometriosis
  • Having a history and/ or active pelvic inflammatory disease
  • Having uterine fibroids
  • Having an adnexal cyst with risk of malignancy
  • Being pregnant

Sites / Locations

  • Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery

Arm Description

Outcomes

Primary Outcome Measures

Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes
Assessment of pop-q quantification staging system before and 6 months after lateral suspension performed via V-notes
Incidence of pelvic organ prolapse/urinary Incontinence and sexual function in patients undergone lateral suspension performed via V-Notes
Assessment of pisq-12 Questionnaire in patients undergone lateral suspension performed via V-Notes

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
July 5, 2022
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05066737
Brief Title
Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique
Official Title
Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
It was aimed to evaluate the quality of life and sexual function of patients by Pre- and postoperative POP-Q (Pelvic Organ Prolapse Quantification) staging and PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) test of patients who underwent lateral suspension operation with V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique.
Detailed Description
NOTES technically means a surgical intervention performed by entering the abdomen through one of the body's natural openings such as mouth, anus, vagina, and urethra. With the flexible endoscope, a hole is made in organs such as stomach, colon, vagina, bladder, and the peritoneal cavity is entered and the area to be studied is provided by filling air. With the V-NOTES (vaginal Vaginal-Natural Orifice Transluminal Endoscopic Surgery) method we will apply, we reject the bladder from the cervix and reach to abdominal cavity by piercing the visceral peritoneum. The abdomen will be viewed via trocars placed in this region and a lateral suspension operation, which is a kind of suspension surgery of pelvic organ prolapsus, will be performed.The POP-Q staging that will be performed before the lateral suspension operation with the V-NOTES Technique will be compared with the POP-Q staging 6 after the operation. In addition, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) test will be used for the evaluation of pelvic organ prolapse, urinary incontinence and sexual function in the same intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse, lateral suspension, v-notes, pop-q, pısq-12

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
lateral suspension via V-NOTES surgery
Intervention Description
pop-q, pisq-12 assesment of patients with pelvic organ prolapse before and 6 or 12 month after lateral suspension surgery performed via V-NOTES technique.
Primary Outcome Measure Information:
Title
Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes
Description
Assessment of pop-q quantification staging system before and 6 months after lateral suspension performed via V-notes
Time Frame
6 months
Title
Incidence of pelvic organ prolapse/urinary Incontinence and sexual function in patients undergone lateral suspension performed via V-Notes
Description
Assessment of pisq-12 Questionnaire in patients undergone lateral suspension performed via V-Notes
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with more than 2nd and 3rd degree uterine prolapsus Patients with more than 2nd and 3rd degree cystocele Exclusion Criteria: Having endometriosis Having a history and/ or active pelvic inflammatory disease Having uterine fibroids Having an adnexal cyst with risk of malignancy Being pregnant
Facility Information:
Facility Name
Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique

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