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Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy

NCT03436147 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2020-09-25

Study results available
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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.

Conditions

  • Pelvic Organ Prolapse

Interventions

OTHER

POP-Q

Pelvic Organ Prolapse Quantification

Sponsors & Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    lead OTHER_GOV

Principal Investigators

  • Cihan Kaya · Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-02-01
Completion
2020-02-01

Countries

  • Turkey (Türkiye)

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 NCT03436147 on ClinicalTrials.gov