Use of v Care in Abdominal Hysterectomy

NCT ID: NCT02371811

Last Updated: 2017-08-01

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-07-31

Brief Summary

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The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.

Detailed Description

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Conditions

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Uterine Fibroid

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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v care group

In this group we will use (v care) uterine manipulator during abdominal hysterectomy.

Group Type EXPERIMENTAL

uterine manipulator (v care)

Intervention Type DEVICE

control group

In this group we will do abdominal hysterectomy without v care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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uterine manipulator (v care)

Intervention Type DEVICE

Other Intervention Names

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v care

Eligibility Criteria

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Inclusion Criteria

* benign causes for hysterectomy

Exclusion Criteria

* malignant causes for hysterectomy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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dr mohammed elsafty

consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohammed elsafty, md

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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m2491

Identifier Type: -

Identifier Source: org_study_id

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