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Outcomes of right lateral minithoracotomy versus conventional sternotomy in patients with mitral valve surgery: a randomized control trial

Outcomes of right lateral minithoracotomy versus conventional sternotomy in patients with mitral valve surgery: a randomized control trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001722
Enrollment
Unknown
Registered
2011-11-20
Start date
2011-12-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral valve disease

Interventions

A:Mitral valve surgery via right lateral minithoracotomy
B:Mitral valve surgery via conventional sternotomy

Sponsors

Zhongshan hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients with isolated mitral valve disease scheduled for mitral valve replacement or mitral valve annuloplasty in the condition that conservative treatment is invalid or indication for surgery is evident; 2) 18 to 75 years old. Male or female; 3) Mitral valve surgery via either right lateral minithoracotomy or conventional sternotomy is suitable; 4) Patients willing to sign the informed consent of this study.

Exclusion criteria

Exclusion criteria: 1) Patients unsuitable for one of the two surgical approaches above-mentioned because of history of chest trauma, infection of the chest area, right chest empyema, surgery for the right lung, etc; 2) Patients with critical condition requiring emergency surgery; 3) Patients with coronary artery disease, congenital heart disease, or aortic valve disease requiring concomitant surgery; 4) Patients with malignant tumor, liver or renal dysfunction, critical condition such as cachexia, or life expectancy less than 2 years; 5) Patients participating in other trials; 6) Patients unwilling to sign the informed consent of this study.

Design outcomes

Primary

MeasureTime frame
operation duration (min);CPB time (min);cross-clamp time (min);ICU stay (days);ventilation time (hours);hospital stay (days);blood transfusion;drainage (ml);preoperative TTE;intraoperative TEE;postoperative TTE;CK;CK-MB;cTnT;lung function;S100B;NSE;CRP;SIRS;VAS evaluation;Neuropsychological Tests;complications;death;3 month postoperative TTE;6 month postoperative TTE;12 month postoperative TTE;length of incision;quality of healing of incision;pain of incision;EQ-5D;cost;minimum cost analysis;

Countries

China

Contacts

Public ContactLai Wei
wei.lai@zs-hospital.sh.cn+86 13818176656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026