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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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