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

G

Gaziosmanpasa Research and Education Hospital

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: lateral suspension via V-NOTES surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05066737
GaziosmanpasaTREHf

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

Female

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery
Experimental group
Treatment:
Procedure: lateral suspension via V-NOTES surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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