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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05066737
Enrollment
38
Registered
2021-10-04
Start date
2021-09-01
Completion date
2022-03-30
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse, lateral suspension, v-notes, pop-q, pısq-12

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.

Interventions

PROCEDURElateral 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.

Sponsors

Gaziosmanpasa Research and Education Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes6 monthsAssessment 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-Notes6 monthsAssessment of pisq-12 Questionnaire in patients undergone lateral suspension performed via V-Notes

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026