Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

Mitral Valve Disease Clinical Trial

Official title:

Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03195595
• Other study ID #: 17100176
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: Elhussein abdelmottaleb, master
• Phone: 00201003873076
• Email: husseinmoh24[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Disease

Intervention

Device:
• mitral valve replacement
early postoperative outcome regarding pain in minimal invasive technique
• conventional mitral valve replacement
early postoperative outcome regarding pain in conventional median sternotomy

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating of postoperative pain by using numerical rating scales (NRS)	its a score result from gathered information from the patient	one year
Secondary	Evaluating early postoperative outcome	e.g., bleeding	one year