An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System.
This is a prospective and retrospective, multi-center, observational registry study evaluating the use of the Senhance Surgical System in paediatric patients undergoing laparoscopically-assisted surgery. The trial is open-label and designed to collect both historical and prospective data from participating centers. Paediatric subjects who have undergone or will undergo procedures with the Senhance Surgical System will be enrolled. The primary purpose for this study is to assess safety outcomes. Secondary endpoints include length of hospital stay, procedural information, and patient-reported outcomes.
Study Type
OBSERVATIONAL
Enrollment
1,000
Patients who undergo surgery utilising the Senhance Surgical System.
Dr. von Hauner Children's Hospital Clinic of the University of Munich
München, Germany
RECRUITINGAdverse Event
Rate of Adverse Event (Clavien \>3)
Time frame: Index surgery to 30 days postoperative
Procedure-related severe adverse event
Percent of procedurally related SAE after adjudication
Time frame: Index surgery to 30 days post-operative
Length of Stay
Total duration (in days) of hospitalization related to the index surgical procedure
Time frame: From day of index procedure to hospital discharge, up to 2 weeks
Conversion to unplanned open surgery
Rate of unplanned conversions from laparoscopic to open surgery.
Time frame: Intraoperative (during index surgical procedure)
COMFORT-B scale for assessing pain in pediatric patients aged 0 to less than 2 years of age
The COMFORT-B Score is a validated behavioral assessment tool designed to evaluate the level of sedation, pain, and distress in pediatric patients. The COMFORT-B scale will be used to assess pain levels in children aged 0 to less than 2 years of age. The COMFORT-B scale includes six behavioral dimensions: Alertness, Calmness/Agitation, Respiratory Response (only in mechanically ventilated children), Crying (only in spontaneously breathing children), Physical Movement, Muscle Tone, and Facial Tension. Each dimension is scored on a scale from 1 to 5, yielding a total score range of 6 to 30. Higher scores indicate greater distress or discomfort.
Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale for children aged 2 years to less than 7 years of age.
The FLACC scale assesses pain by observing five categories of behaviors and assigning a score of 0-2 to each category, resulting in a total score of 0-10, where a score of 10 indicates a higher level of pain. The following five behavioral categories are assessed: Facial expression, leg movement, Activity level, Crying, and Consolability. The FLACC scale will be utilized to assess pain in children aged 2 to less than 7 years of age.
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Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Numerical Rating Scale (NRS) for assessing pain in patients aged 7 years to less than 18 years of age.
Pain will be assessed using a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain). The NRS scale will be used for patients aged 7 years to less than 18 years of age.
Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.