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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: lateral suspension via V-NOTES surgery

• Registration Number: NCT05066737
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-04
• Status Verified: 2022-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-03-30
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery	lateral suspension via V-NOTES surgery	-

Primary Outcome Measures

Name	Time	Method
Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes	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	6 months	Assessment of pisq-12 Questionnaire in patients undergone lateral suspension performed via V-Notes

Trial Locations

Locations (1)

Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital; 🇹🇷 Istanbul, Turkey