Clinical trial NCT05066737: Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique
Official title: Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
lateral suspension
v-notes
pop-q
pısq-12
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-04
Enrollment: 38
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes
timeFrame: 6 months
measure: Incidence of pelvic organ prolapse/urinary Incontinence and sexual function in patients undergone lateral suspension performed via V-Notes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital
Study officials:
References: