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Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
prolapse surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pelvic Organ Prolapse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women Health Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prolapse surgery

Arm Description

Outcomes

Primary Outcome Measures

levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2019
Last Updated
March 3, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03857724
Brief Title
Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries
Official Title
Clinical and Three-dimensional Ultrasound Assessment of Cases With Apical Prolapse Surgeries. A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prolapse surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
prolapse surgery
Intervention Description
prolapse surgery
Primary Outcome Measure Information:
Title
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
Description
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
Time Frame
2 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Pregnancy Postpartum women during the 1st 6 months postpartum Human papillomavirus vulvar disease (condyloma acuminata) Patient unfit for surgery Previous pelvic reconstruction surgery. Factors affecting healing process as uncontrolled diabetes, steroid therapy, on chemotherapy,….. etc
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Eldin Yousef
Phone
01222442140
Email
alaaeldinabdelhamid60@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Bahloul
Phone
01011186323
Email
bahloolmm@yahoo.com
Facility Information:
Facility Name
Women Health Hospital
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
10413222
Citation
Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse? Eur J Obstet Gynecol Reprod Biol. 1999 May;84(1):23-5. doi: 10.1016/s0301-2115(99)00002-0.
Results Reference
result
PubMed Identifier
30723744
Citation
Lin KL, Juan YS, Chou SH, Long CY. Ultrasonographic Assessment with Three-Dimensional Mode of the Urethral Compression Effect following Sling Surgery with and without Mesh Surgery. Biomed Res Int. 2019 Jan 6;2019:8285351. doi: 10.1155/2019/8285351. eCollection 2019.
Results Reference
result

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Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries

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