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

Sponsor

Gaziosmanpasa Research and Education Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05066737

Collaborator

(none)

Enrollment

Location

Arm

6.9

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: lateral suspension via V-NOTES surgery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Mar 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

Gaziosmanpasa Research and Education Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Süleyman Salman, associate professor, Gaziosmanpasa Research and Education Hospital

ClinicalTrials.gov Identifier:

NCT05066737

Other Study ID Numbers:

GaziosmanpasaTREHf

First Posted:

Oct 4, 2021

Last Update Posted:

Jul 6, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Süleyman Salman, associate professor, Gaziosmanpasa Research and Education Hospital

pelvic organ prolapse

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Jul 6, 2022