CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
POP-Qother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03436147
NCT03436147N/ACompleted

Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse: a Prospective Randomized Study

Bakirkoy Dr. Sadi Konuk Research and Training Hospital·observational·Posted Feb 19, 2018·Updated Sep 25, 2020

In Brief

An observational study evaluating POP-Q for Pelvic Organ Prolapse. Completed, enrolled 49 participants across 1 site.

Detailed Summary

Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on patient-centered medicine and patient-generated definitions of surgical success has resulted in reassessment of uterine preservation versus hysterectomy at the time of apical POP repair. Various techniques have been described for uterine preserving prolapse surgery, which may include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was introduced and a series of 70 women was reported. To date, there have been no randomized studies comparing the outcomes of vaginal assisted laparoscopic uterine suspension (hysteropexy) with conventional vaginal hysterectomy. Women attending the gynecology clinic at a tertiary referral urogynecology unit in tertiary referral training and research hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse will be offered participation in a randomized trial, over a 2-year period. Subjects participating in the study were randomly assigned to either of two groups: Group A, Vaginally Assisted Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and Mc Call Culdoplasty (VH + Mc Call).1 year following surgery, vaginal prolapse will be assessed again using the International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS) questionnaire and the Pelvic Organ Prolapse -Quantification (POP-Q) examination by another researcher then the operator.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 19, 2018
Enrollment StartFeb 1, 2018
Primary CompletionFeb 1, 2019
Study CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 8.4 years ago

Interventions

POP-Qother

Pelvic Organ Prolapse Quantification