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

NCT ID: NCT03772015

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-09

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prolapse Genital Anatomical Pathological Condition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Magnetic resonance imaging

Intervention Type 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

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

Magnetic resonance imaging

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bartin State Hospital

OTHER_GOV

Sponsor Role collaborator

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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OZAN DOGAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ozan Dogan, MD

Role: PRINCIPAL_INVESTIGATOR

Hamidiye Sisli Etfal Training and Research Hospital

Murat Yassa, MD

Role: PRINCIPAL_INVESTIGATOR

Bartin State Hospital

Locations

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Hamidiye Sisli Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28816554 (View on PubMed)

Other Identifiers

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240918

Identifier Type: -

Identifier Source: org_study_id

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