Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

• Conditions: Mitral Valve Disease
• Interventions: Device: mitral valve replacement; Device: conventional mitral valve replacement

• Registration Number: NCT03195595
• Lead Sponsor: Assiut University

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Study Start: 2020-04-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Symptomatic patients with mitral valve disease indicated for valve surgery

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mitral valve replacement	conventional mitral valve replacement	patients whom underwent Mitral valve replacement through minimal invasive incision
mitral valve replacement	mitral valve replacement	patients whom underwent Mitral valve replacement through minimal invasive incision

Primary Outcome Measures

Name	Time	Method
Evaluating of postoperative pain by using numerical rating scales (NRS)	one year	its a score result from gathered information from the patient

Secondary Outcome Measures

Name	Time	Method
Evaluating early postoperative outcome	one year	e.g., bleeding

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt