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Table 4 Surgery characteristics and observations

From: A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

 

6 months surgery

12 months surgery

Overall

Number of patients

XX

XX

XX

Baseline surgery characteristics

 Grading of cleft at surgery

 N

XX

XX

XX

 Grade1; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Grade 2; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Grade 3; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Grade 4; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Shape of cleft

 N

XX

XX

XX

 “U” shaped; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 “V” shaped; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Dimensions of cleft palate (mm)

 Soft tissue width at posterior hard plate

 N

XX

XX

XX

 Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 (Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

 Not known; n

XX

XX

XX

 Bony width at posterior hard palate

 N

XX

XX

XX

 Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 (Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

 Not known; n

XX

XX

XX

 Width at base of uvula

 N

XX

XX

XX

 Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 (Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

 Not known; n

XX

XX

XX

 Length of soft palate (distal base of uvula-hard palate)

 N

XX

XX

XX

 Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

 (Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

 Not known; n

XX

XX

XX

Intra-operative events

 Blood transfusion during surgery

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Anaesthetic complications

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Bleeding

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

Early complications during the hospital stay

 Postoperative airway problems

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Postoperative blood loss

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Anti-coagulants given

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Dehiscence

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Readmission to operating room

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

Observations monitored in first 48 h post-surgery

 Oxygen saturation levels

 N

XX

XX

XX

 Clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No observation; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Carbon dioxide and oxygen

 N

XX

XX

XX

 Clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No observation; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Arterial blood gases

 N

XX

XX

XX

 Clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No observation; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Heart rate

 N

XX

XX

XX

 Clinically significant abnormality and treatment required; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Clinically significant abnormality and no treatment required; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No observation; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Blood pressure

 N

XX

XX

XX

 Clinically significant abnormality and treatment required; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Clinically significant abnormality and no treatment required; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No observation; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Respiration

 N

XX

XX

XX

 Clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No observation; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Body temperature

 N

XX

XX

XX

 Clinically significant abnormality and treatment required; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Clinically significant abnormality and no treatment required; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No clinically significant abnormality; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No observation; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

Postoperative medication

 Pain relief medication

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Anti-inflammatory medication

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

 Antibiotic medication (other than prophylactic antibiotics)

 N

XX

XX

XX

 Yes; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 No; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Not known; n

XX

XX

XX

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Trials

ISSN: 1745-6215