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Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair

NCT05628831 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-05-09

No results posted yet for this study

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)

Conditions

  • Vaginal Vault Prolapse

Interventions

PROCEDURE

vNOTES suspension with autologous tissue

Autologous tissue will be fixated on solid points in pelvis using vNOTES.

PROCEDURE

Vaginal surgery

Vaginal hysterectomy will be done with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Uterosacral and cardinal ligaments will be repositioned and attached to the vaginal vault after hysterectomy at the time of vault closure. A modified McCall culdoplasty will be done in this group to prevent enterocele and further apical prolapse

Sponsors & Collaborators

  • General Hospital Zadar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-18
Primary Completion
2023-09-10
Completion
2024-09-10

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628831 on ClinicalTrials.gov