Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05628831

Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair

Conditions: Vaginal Vault Prolapse

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 56
Sponsor: General Hospital Zadar

Location: Croatia

Summary

The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of re-operation for anterior, posterior or apical prolapse within the study period.Participants with a POP-Q (Pelvic Organ Prolapse Quantification) of 3 or 4 and an indication for hysterectomy and prolapse repair will be selected and randomly divided in two groups. One group will be operated with standard technique for pelvic organ prolapse and in the other autologous graft will be used using vNOTES ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used as a subjective measurement of operative treatment.Objective evaluation of the effect of postoperative results will be done using transperineal ultrasound before operation, 6 and 12 months after procedure.EXPECTED CONTRIBUTION: In this research we will evaluate the feasibility and surgical outcome of vaginal NOTES (vNOTES) prolapse repair using posterior rectus fascia (PREFAP- Posterior Rectus Fascia Prolapse repair)

Eligibility Criteria

Inclusion Criteria:patients older than 18 years old with no desire to preserve fertility, POP-Q 3 or 4 stage of prolapse with indication for hysterectomy (abnormal uterine bleeding, enlarged fibrous uterus, premalignant cervical findings)Exclusion Criteria:Virginity, pregnancy, acute urinary infection were considered contraindications; malignancy, previous PID or rectal surgery. Rectovaginal endometriosis. Contraindication for general anaesthesia, pneumoperitoneum or Trendelenburg position. Previous pelvic radiotherapy

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05628831). StuddyBuddy aggregates publicly available trial information.