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Clinical Trials/NCT05066737
NCT05066737
Completed
Not Applicable

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

Gaziosmanpasa Research and Education Hospital1 site in 1 country38 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Gaziosmanpasa Research and Education Hospital
Enrollment
38
Locations
1
Primary Endpoint
Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
March 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Süleyman Salman

associate professor

Gaziosmanpasa Research and Education Hospital

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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