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

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ClinicalTrials.gov Identifier: NCT03772015
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Bartin State Hospital
Information provided by (Responsible Party):
OZAN DOGAN, Sisli Hamidiye Etfal Training and Research Hospital

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.

Condition or disease Intervention/treatment
Prolapse Genital Anatomical Pathological Condition Diagnostic Test: Magnetic resonance imaging

Detailed Description:
Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. To prove the null hypothesis, it is planned to compare the vaginal axis on Magnetic Resonans Imaging taken preoperatively and postoperatively in patients who are scheduled for lateral mesh suspension for apical prolapse.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension
Actual Study Start Date : December 9, 2018
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
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
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
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
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.




Primary Outcome Measures :
  1. Vaginal axis [ Time Frame: at 6th months after the operation ]

    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.


  2. Vaginal distances [ Time Frame: at 6th months after the operation ]
    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.


Secondary Outcome Measures :
  1. Urge Symptoms [ Time Frame: Evaluation at postoperative 6th month ]
    Michigan Incontinence Severity Index (M-ISI) scale will be used to assess subjective outcome including urge symptoms. This scale has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for urge urinary incontinence [UUI], and items 7 and 8 for Pad usage [PU]. The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point).

  2. Prolapse symptoms [ Time Frame: Evaluation at postoperative 6th month ]
    The POP-SS consists of seven items, each with a 5-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). A total score (range 0-28) is calculated by summing the seven individual symptom responses to derive the POP-SS score. In addition, women indicate which one of the seven symptoms causes them most bother.

  3. Sexual functions [ Time Frame: Evaluation at postoperative 6th month ]
    The FSFI evaluates sexual functioning in women and comprises of 19 questions with different answer choice scales referring the sexual life in the previous 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter, there is a threshold at 26.55 which means tFhat all values below are classed as indicating female sexual dysfunction (FSD). The domain scores are obtained as the sum of points attributed to questions in that domain multiplied by the domain factor.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who are scheduled for lateral mesh suspension operation to treat apical prolapse.
Criteria

Inclusion Criteria:

  • Female genital prolapse

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772015


Locations
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Turkey
Hamidiye Sisli Etfal Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
Bartin State Hospital
Investigators
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Principal Investigator: Ozan Dogan, MD Hamidiye Sisli Etfal Training and Research Hospital
Principal Investigator: Murat Yassa, MD Bartin State Hospital
Publications:
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Responsible Party: OZAN DOGAN, Principal Investigator, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03772015    
Other Study ID Numbers: 240918
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OZAN DOGAN, Sisli Hamidiye Etfal Training and Research Hospital:
laparoscopic lateral mesh suspension
lateral abdominocervicopexy
apical prolapse
anterior prolapse
vaginal axis
magnetic resonance imaging
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical