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

July 5, 2022 updated by: Süleyman Salman, Gaziosmanpasa Research and Education Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital

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

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery
Procedure: lateral suspension via V-NOTES surgery
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Gaziosmanpasa Research and Education Hospital

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 (ACTUAL)

September 1, 2021

Primary Completion (ACTUAL)

February 28, 2022

Study Completion (ACTUAL)

March 30, 2022

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (ACTUAL)

October 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaTREHf

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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