Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy

NCT03436147 | Completed Results

• 1 other identifier: VALHvsVAH
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vaginal hysterectomy; laparoscopic hysteropexy; pelvic organ prolapse quantification

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrence of Pelvic Organ Prolapse

  Number of Participants with Recurrence of Pelvic Organ Prolapse

  Postoperative first year

Secondary Outcomes (2)

• POP-Q SYSTEM Point C MEASUREMENT

  change from preoperative measurement of pop-q point c at postoperative first year

• ICIQ-VS Vaginal Symptom Subscale

  change from preoperative ICIQ-VS vaginal symptom subscale score at postoperative first year

Study Arms (2)

Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH)

Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH)

Other: POP-Q

Vaginal Hysterectomy and Vaginal vault suspension (VAH+VVS)

Patients who were performed vaginal hysterectomy and vaginal vault suspension(VAH+VVS)

Other: POP-Q

Interventions

POP-Q OTHER

Pelvic Organ Prolapse Quantification

Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH); Vaginal Hysterectomy and Vaginal vault suspension (VAH+VVS)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women attending the gynecology clinic at a tertiary referral urogynecology unit in our hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse.

You may qualify if:

• patients who are over 35 years of age with no desire to preserve fertility. (Subjects had completed childbearing or were practicing reliable contraception)
• have a normal size uterus (\<10 cm) on examination or ultrasound
• who agree to participate in principle will be given further information about the trial and consent will be obtained either in an outpatient clinic or at the next visit for preoperative assessment.

You may not qualify if:

• cervical elongation (surgeon discretion),
• prior mesh prolapse repair,
• current foreign-body complications,
• increased risk or recent history of cervical dysplasia, chronic pelvic pain, significant uterine abnormalities, and abnormal menstruation.
• postmenopausal bleeding in the past 12 months
• women with a significantly enlarged fibroid uterus
• concomitant medical problems precluding general anesthesia or the use of a steep trendelenberg position

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ismail Alay
• Organization: bakirkoy dr sadi konuk training and research hospital

dr_ismailalay@hotmail.com

+905462375638

Study Officials

• Cihan Kaya

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 19, 2018
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: September 25, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-09

Locations

TU (1)