Here is the design of a clinical trial:

Official Title: Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations

Included conditions:
- Funnel Chest

Study Armgroups:
- {'label': 'The study population', 'type': 'OTHER', 'description': 'Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period.\n\nIntervention: Surgical correction of pectus excavatum', 'interventionNames': ['Procedure: Surgical correction of pectus excavatum']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Surgical correction of pectus excavatum', 'description': 'Surgical correction of pectus excavatum', 'armGroupLabels': ['The study population']}

Primary Outcomes:
- {'measure': 'Change in: Oxygen pulse (mL O2 / heart beat)', 'description': 'Recorded during incremental exercise testing.', 'timeFrame': 'post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))'}

Please estimate the sample size based on the assumption: 
Type 1 error rate set at α=0.05 and power at 90% (type 2 error: β=0.10).
Sample size
        According to data collected in a previous study (NCT03086499), we are expecting a presurgical O2-pulse at around 13.2Â±3.4âmL O2/min. In order to detect a moderate effect size associated with surgical PE correction (ie, a Cohenâs effect size of d=0.5, corresponding to a postoperative change in O2 pulse of 1.5Â±3âmL O2/min) with a type 1 error rate set at Î±=0.05âand power at 90% (type 2 error: Î²=0.10), 44 data points would be required. In order to allow for a large loss to follow-up (this rather young population can be hard to follow), we propose including 70âpatients.
        
          Logistics
          The practical deployment of this study is based on the routine pathways of patients coming in for postsurgical check-ups (historical prospective cases) or for presurgical assessments (prospective cases). To this end, upcoming consultation lists within the department were systematically screened for potential candidates. All consecutive patients were targeted to avoid recruitment bias. Candidates were proposed study participation and appropriate consent procedures during their next consult. An overview of the study visits and associated assessments is presented in table 3.
          
            Table 3
            
              The visits and assessments occurring during the HeartSoar study
            
            
              
                
                  Visit:
                  Preoperative consult
                  Surgery
                  Postoperative follow-up
                
              
              
                
                  Timeframe
                  â4 to â1âmonths
                  Day 0
                  A single visit at 12, 24, 36 or 48âmonths (Â±3âmonths)
                
                
                  Historical-prospective inclusions
                
                
                  âVerification of eligibility criteria
                  
                  
                  â«
                
                
                  âConsent procedures
                  
                  
                  â«
                
                
                  Prospective inclusion with a single visit at 12âmonths
                
                
                  âVerification of eligibility criteria
                  â«
                  
                  
                
                
                  âConsent procedures
                  â«
                  
                  
                
                
                  Intervention evaluated via the before-after design
                
                
                  âSurgical correction of pectus excavatum
                  
                  â«*
                  
                
                
                  Assessments/data recording
                
                
                  âBaseline data recording
                  â«*
                  
                  
                
                
                  âIncremental exercise testing
                  â«*
                  
                  â«
                
                
                  âLung volumes and function
                  â«*
                  
                  â«
                
                
                  âBMI, body composition and weight intentions
                  â«*
                  
                  â«
                
                
                  âQuestionnaires (SF-36, RSES, BES)
                  â«â 
                  
                  â«
                
                
                  âSurgical data recording
                  
                  â«*
                  
                
                
                  âHaemodynamic variation during surgery
                  
                  â«â 
                  
                
                
                  âComplications
                  
                  â«*
                  â«
                
              
            
            
              
                *For historical-prospective inclusions, these data are recovered in as much as possible from patient files.
              
              
                â Prospective inclusions only.
              
              
                BES, Body Esteem Scale; BMI, bodyâmass index; RSES, RosenbergâSelf Esteem Scale; SF-36, ShortâForm 36.
              
            
          
        
        
          Historical-prospective inclusions
          Only one visit, a routine postoperative consult, is required for historical-prospective inclusions (table 3). These routine visits are performed annually at the participating hospital and may occur at approximately 12, 24, 36 or 48âmonths after surgery, with generous leeway (Â±3âmonths). During this visit, the study will be proposed to the patient, and consent procedures are implemented if he/she is interested in participating. In addition to the recovery of baseline data, assessments are performed in line with table 3, namely, incremental exercise testing, pulmonary volumes and function, BMI, body fat percentage and quality-of-life/self-esteem questionnaires.
        
        
          Prospective inclusions
          Patients in this group have not yet had corrective surgery and are invited to participate in the study during their presurgical work-up, which will include the assessments listed in table 3. Patients will then follow a routine pathway, with a postsurgical follow-up visit at 1âyear following surgery. The data recovered enable a beforeâafter evaluation of the effect of surgical correction of PE on variables issuing from key HeartSoar assessments, namely, incremental exercise testing, pulmonary volumes and function, BMI, body composition and quality-of-life/self-esteem questionnaires.