Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

NCT ID: NCT02667002

Last Updated: 2022-03-28

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

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-06-30

Brief Summary

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Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.

Detailed Description

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Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilateral Abdominal Sacral Hysteropexy

Bilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

Group Type EXPERIMENTAL

Bilateral Abdominal Sacral Hysteropexy

Intervention Type PROCEDURE

The mesh will be fixed right and left side of sacrum.

Classic Abdominal Sacral Hysteropexy

Conventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

Group Type EXPERIMENTAL

Conventional abdominal Sacral Hysteropexy

Intervention Type PROCEDURE

The mesh will be fixed only right side of sacrum

Women with no uterovaginal prolapsed

Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

Group Type ACTIVE_COMPARATOR

Nulliparous women with no uterovaginal prolapsed

Intervention Type OTHER

This will be control group which consistent patients with no uterovaginal prolapse.

Interventions

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Bilateral Abdominal Sacral Hysteropexy

The mesh will be fixed right and left side of sacrum.

Intervention Type PROCEDURE

Conventional abdominal Sacral Hysteropexy

The mesh will be fixed only right side of sacrum

Intervention Type PROCEDURE

Nulliparous women with no uterovaginal prolapsed

This will be control group which consistent patients with no uterovaginal prolapse.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women with stage 3 or more pelvic organ prolapse

Exclusion Criteria

* Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Baki Senturk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Baki Şentürk, MD

Role: STUDY_DIRECTOR

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

References

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Jager W, Mirenska O, Brugge S. Surgical treatment of mixed and urge urinary incontinence in women. Gynecol Obstet Invest. 2012;74(2):157-64. doi: 10.1159/000339972. Epub 2012 Aug 9.

Reference Type RESULT
PMID: 22890409 (View on PubMed)

Sze EH, Meranus J, Kohli N, Miklos JR, Karram MM. Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):375-9; discussion 379-80. doi: 10.1007/s001920170016.

Reference Type RESULT
PMID: 11795640 (View on PubMed)

Joukhadar R, Meyberg-Solomayer G, Hamza A, Radosa J, Bader W, Barski D, Ismaeel F, Schneider G, Solomayer E, Baum S. A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bilateral Sacropexy. Biomed Res Int. 2015;2015:860784. doi: 10.1155/2015/860784. Epub 2015 Apr 19.

Reference Type RESULT
PMID: 25961042 (View on PubMed)

Other Identifiers

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162

Identifier Type: -

Identifier Source: org_study_id

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