The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension

NCT03772015 | Completed

• 1 other identifier: 240918
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse. Investigators hypothesized that uterus-preserving lateral suspension provides a better anatomical positioning.

Conditions

Prolapse Genital; Anatomical Pathological Condition

Keywords

laparoscopic lateral mesh suspension; lateral abdominocervicopexy; apical prolapse; anterior prolapse; vaginal axis; magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• Vaginal axis

  From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated. The angles between the pubococcygeal line and lower vaginal segment (angle A), between the levator plate and the pubococcygeal (angle B) and between lower and upper vaginal segments (angle C) will be measured.

  at 6th months after the operation

• Vaginal distances

  The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.

  at 6th months after the operation

Secondary Outcomes (3)

• Urge Symptoms

  Evaluation at postoperative 6th month

• Prolapse symptoms

  Evaluation at postoperative 6th month

• Sexual functions

  Evaluation at postoperative 6th month

Study Arms (2)

Study

Patients who had the operation of "laparoscopic lateral mesh suspension" for apical prolapse will have magnetic resonance imaging preoperatively and at postoperative 6th month

Diagnostic Test: Magnetic resonance imaging

Control

Multiparous, sexually active participants who have grade 0 or 1 (asymptomatic if exists) prolapse will have magnetic resonance imaging as a control group

Diagnostic Test: Magnetic resonance imaging

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

MRI will be performed using a standard body spiral in the supine position with 5 mm section thickness, on the axial, coronal and sagittal planes and the diffusion weighted images acquired will be evaluated by a specialised radiologist who will be blind to the participants.

Control; Study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are scheduled for lateral mesh suspension operation to treat apical prolapse.

You may qualify if:

• Female genital prolapse

You may not qualify if:

• Patients who had pouch of Douglas obliteration
• Patients with enterocele
• Patients who have any congenital or acquired anatomic and reproductive anomaly

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead
• Bartin State Hospital: collaborator

Study Sites (1)

Hamidiye Sisli Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.

  PMID: 28816554 BACKGROUND

MeSH Terms

Conditions

Pathological Conditions, Anatomical

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ozan Dogan, MD

  Hamidiye Sisli Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Murat Yassa, MD

  Bartin State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 11, 2018
• Study Start: December 9, 2018
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)