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Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

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ClinicalTrials.gov Identifier: NCT03195595
Recruitment Status : Unknown
Verified June 2017 by Elhussein Mohamed Abdelmottaleb, Assiut University.
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Elhussein Mohamed Abdelmottaleb, 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

Condition or disease Intervention/treatment
Mitral Valve Disease Device: mitral valve replacement Device: conventional mitral valve replacement

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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

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



Primary Outcome Measures :
  1. Evaluating of postoperative pain by using numerical rating scales (NRS) [ Time Frame: one year ]
    its a score result from gathered information from the patient


Secondary Outcome Measures :
  1. Evaluating early postoperative outcome [ Time Frame: one year ]
    e.g., bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
It includes groups of population above age of 18 with symptomatic mitral valve disease indicated for valve surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195595


Contacts
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Contact: Elhussein abdelmottaleb, master 00201003873076 husseinmoh24@gmail.com

Locations
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Egypt
Assiut University Hospitals Recruiting
Assiut, Egypt
Contact: Elhussein abdelmottaleb, master    00201003873076    husseinmoh24@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: mohamed A nady, lecturer Assuit university hospital

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Responsible Party: Elhussein Mohamed Abdelmottaleb, Resident doctor at cardiothoracic surgery, Assiut University
ClinicalTrials.gov Identifier: NCT03195595     History of Changes
Other Study ID Numbers: 17100176
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No