Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries

March 3, 2019 updated by: Andrew Yacoub Shafeek, Assiut University

Clinical and Three-dimensional Ultrasound Assessment of Cases With Apical Prolapse Surgeries. A Prospective Cohort Study

The levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major levator ani defects are associated with pelvic organ prolapse (POP) and POP recurrence

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

The aetiology of female pelvic organ prolapse (FPOP) is complex and likely due to a combination of factors. Genetics, race, aging and menopause, obesity and conditions associated with a chronically increased intra-abdominal pressure such as chronic obstructive pulmonary disease as well as childbirth trauma have been implicated. Delivery-related trauma to the pubovisceral muscle is common and obviously associated with female pelvic organ prolapse.

It is a common problem with an incidence as high as 40%, and 10-20% of women will require surgery for prolapse at least once in their lifetime.

The levator hiatus defines the 'hernial portal' through which FPOP develops. Childbirth clearly leads to an enlargement of the levator hiatus, even in the absence of levator trauma.

And the levator hiatal dimensions are strongly associated with FPOP and with prolapse recurrence Enlargement of the levator hiatus is more likely to be the cause rather than the effect of FPOP. Alterations of the levator hiatus morphology following delivery have been demonstrated using magnetic resonance imaging (MRI) and more recently, three-dimensional (3D) ultrasound imaging Magnetic resonance imaging (MRI) has been shown to visualize levator ani defects effectively, but in recent years, translabial 3- and 4-dimensional (3D/4D) ultrasound has shown to provide valuable information on biometrical properties of the pelvic floor and morphology of the levator ani muscle.And recently three-dimensional ultrasonography is an alternative for MRI in detecting levator defects.

Currently, technologic advances in 3D ultrasonography allow access to the arbitrarily defined planes anywhere within ultrasound volume data and permit direct imaging of the entire levator hiatus.

Translabial three-dimensional ultrasonography has practical advantages because it is less expensive, easily accessible, and more readily available for gynecologists.

3D-Ultrasound in urogynecology could be helpful in diagnosing of urinary incontinence and urethral hypermobility, to document pelvic floor anatomy and to assess anatomic and functional changes before and after gynecologic surgery.

The objective of our research was to detect levator ani defects in women with POP before and after apical prolapse surgeries and if they will be corrected after the operation or not.

The secondary objective was to 1)detect the most appropriate surgical procedure in restoring the dimensions of the hiatal area.

2)Correlate between the levator ani defects and the complains, quality of life questionnaires, clinical examination of the patient before and after the surgery.

3)The role of 3D-Ultrasound in diagnosing the pelvic floor defects and targeting the Surgical procedure to restore the defects.

4)Introduce and stress on POP-Q system into Assuit general hospital and Abuteeg Hospital as it will be used to evaluate all cases both pre-operatively and during post-operative follow up being the standard method for evaluating cases of pelvic organ prolapse.

Objective cure was defined as the: absence of the prolapse as indicated by a POP-Q stage of 0-1.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Women Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

I. Arabic female that is able to understand the instructions and the questionnaires that will be given II. Apical prolapse Stage 2-4 (according to POP-Q)(30,33) III. Sexually active (at least 3 times every month)

Exclusion Criteria:

  1. Pregnancy
  2. Postpartum women during the 1st 6 months postpartum
  3. Human papillomavirus vulvar disease (condyloma acuminata)
  4. Patient unfit for surgery
  5. Previous pelvic reconstruction surgery.
  6. Factors affecting healing process as uncontrolled diabetes, steroid therapy, on chemotherapy,….. etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: prolapse surgery
Procedure: prolapse surgery
prolapse surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
Time Frame: 2 years
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3D ULTRASOUND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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