Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach
1 other identifier
observational
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedJune 12, 2020
June 1, 2020
1.6 years
June 5, 2017
June 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluating of postoperative pain by using numerical rating scales (NRS)
its a score result from gathered information from the patient
one year
Secondary Outcomes (1)
Evaluating early postoperative outcome
one year
Study Arms (2)
mitral valve replacement
patients whom underwent Mitral valve replacement through minimal invasive incision
conventional mitral valve replacement
patients whom underwent Mitral valve replacement through conventional sternotomy
Interventions
early postoperative outcome regarding pain in minimal invasive technique
early postoperative outcome regarding pain in conventional median sternotomy
Eligibility Criteria
It includes groups of population above age of 18 with symptomatic mitral valve disease indicated for valve surgery
You may qualify if:
- Symptomatic patients with mitral valve disease indicated for valve surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University Hospitals
Asyut, Egypt
Study Officials
- STUDY DIRECTOR
mohamed A nady, lecturer
Assuit university hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident doctor at cardiothoracic surgery
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 22, 2017
Study Start
April 1, 2020
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
June 12, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share