A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement

Not Applicable

Completed

• Conditions: Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery; Surgery; Sternotomy

• Registration Number: ISRCTN58128724
• Lead Sponsor: Papworth Hospital NHS Foundation Trust (UK)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30075959 (added 01/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-24
• Study Completion: 2012-09-01
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

1. Aged greater than 18 years at the time of surgery, either sex
2. Elective, first time, isolated aortic valve replacement (AVR)

Exclusion Criteria

1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30%
2. Documented chest wall deformities
3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD)
4. Current body mass index (BMI) greater than 35 kg/m^2
5. Concomitant cardiac surgery
6. Redo surgery
7. Median sternotomy indicated

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total length of stay in hospital for the index AVR operation measured in days

Secondary Outcome Measures

Name	Time	Method
<br> 1. Fitness for discharge<br> 2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG)<br> 3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery<br> 4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion<br> 5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months<br>