Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

NCT ID: NCT03195595

Last Updated: 2020-06-12

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-10-31

Brief Summary

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This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain

Detailed Description

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This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration and the study tools will be:

Part I (Demographic data):

* Age, Gender, Weight, Height ,Smoke history

Part II (Preoperative data):

* Medical history, Clinical assessment, Preoperative investigation

Part III (Intraoperative data):

* Surgical time, and Ischemic time

Part IV (Postoperative data):

* Early ambulation, ICU stay, length of ventilation, using of analgesic drugs, post op bleeding, deaths

Conditions

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Mitral Valve Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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mitral valve replacement

patients whom underwent Mitral valve replacement through minimal invasive incision

mitral valve replacement

Intervention Type DEVICE

early postoperative outcome regarding pain in minimal invasive technique

conventional mitral valve replacement

Intervention Type DEVICE

early postoperative outcome regarding pain in conventional median sternotomy

conventional mitral valve replacement

patients whom underwent Mitral valve replacement through conventional sternotomy

No interventions assigned to this group

Interventions

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mitral valve replacement

early postoperative outcome regarding pain in minimal invasive technique

Intervention Type DEVICE

conventional mitral valve replacement

early postoperative outcome regarding pain in conventional median sternotomy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic patients with mitral valve disease indicated for valve surgery

Exclusion Criteria

* Double valve disease or other valve disease
* Mitral or aortic valve disease associated with ischemic heart disease
* Mitral or aortic valve disease associated with congenital heart disease
* Patients subjected to prior heart surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Elhussein Mohamed Abdelmottaleb

Resident doctor at cardiothoracic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohamed A nady, lecturer

Role: STUDY_DIRECTOR

Assuit university hospital

Locations

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Assiut University Hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Elhussein abdelmottaleb, master

Role: CONTACT

00201003873076

Facility Contacts

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Elhussein abdelmottaleb, master

Role: primary

00201003873076

Other Identifiers

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17100176

Identifier Type: -

Identifier Source: org_study_id

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