Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse

NCT ID: NCT03722563

Last Updated: 2021-02-12

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-08

Study Completion Date

2021-01-22

Brief Summary

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This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse

Detailed Description

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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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TLHS

total laparoscopic hysterectomy with sacrocolpopexy will be performed

Group Type ACTIVE_COMPARATOR

total laparoscopic hysterectomy with sacrocolpopexy

Intervention Type PROCEDURE

Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy

TLHLS

total laparoscopic hysterectomy with lateral suspension will be performed

Group Type EXPERIMENTAL

total laparoscopic hysterectomy with lateral suspension

Intervention Type PROCEDURE

Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy

Interventions

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total laparoscopic hysterectomy with sacrocolpopexy

Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy

Intervention Type PROCEDURE

total laparoscopic hysterectomy with lateral suspension

Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management

Exclusion Criteria

* Patients that are not candidates for general anesthesia or laparoscopy
* Inability to consent
* history of hysterectomy
* history of anterior or apical pelvic organ prolapse surgery
* history of urinary incontinence surgery
* pregnancy or breast-feeding during the study period
* suspicious adnexal masses or other factors that may indicate pelvic malignancy
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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bekirsitkiisenlik

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bekir Sıtkı İsenlik, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

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Antalya Training and Research Hospital

Antalya, Muratpaşa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TLHSvsTLHLS

Identifier Type: -

Identifier Source: org_study_id

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