Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

June 11, 2020 updated by: Elhussein Mohamed Abdelmottaleb, Assiut University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

It includes groups of population above age of 18 with symptomatic mitral valve disease indicated for valve surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mitral valve replacement
patients whom underwent Mitral valve replacement through minimal invasive incision
Device: mitral valve replacement
early postoperative outcome regarding pain in minimal invasive technique
Device: conventional mitral valve replacement
early postoperative outcome regarding pain in conventional median sternotomy
conventional mitral valve replacement
patients whom underwent Mitral valve replacement through conventional sternotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating of postoperative pain by using numerical rating scales (NRS)
Time Frame: one year
its a score result from gathered information from the patient
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating early postoperative outcome
Time Frame: one year
e.g., bleeding
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: mohamed A nady, lecturer, Assuit University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 17100176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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