Surgery, Surgery in Early Childhood
Conditions
Keywords
Robotic, Laparoscopic, Senhance
Brief summary
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.
Detailed description
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.
Interventions
DEVICESurgery
Patients who undergo surgery utilising the Senhance Surgical System.
Sponsors
Asensus Surgical
RQM+
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* \< 18 years of age * Body weight \> 10 kg * Indication for a potential robot-assisted operation * Expected survival of \> 3 months
Exclusion criteria
* Subjects requiring surgery on the heart or greater vessels. * Subjects for whom a laparoscopic approach and endoscopic approach in the thoracic area is not appropriate. * Anaesthetic contraindications, children with pacemakers or other implants for which electrosurgery must be avoided, children with cancer, parents who prefer to proceed with classical or manual laparoscopic surgery. * Subjects pregnant over the second trimester of pregnancy. * Parents or children with insufficient understanding of the site's local language (e.g. Dutch, German) or English language. * Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters due to which an endoscopic or laparoscopic surgical technique is contraindicated. * Subjects who would require an intervention to the upper mediastinum or to the upper pleural cavity regions as referred in the Senhance Surgical System User Manual (UM-001-00035\_CE).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | Index surgery to 30 days postoperative | Rate of Adverse Event (Clavien \>3) |
| Procedure-related severe adverse event | Index surgery to 30 days post-operative | Percent of procedurally related SAE after adjudication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | From day of index procedure to hospital discharge, up to 2 weeks | Total duration (in days) of hospitalization related to the index surgical procedure |
| Conversion to unplanned open surgery | Intraoperative (during index surgical procedure) | Rate of unplanned conversions from laparoscopic to open surgery. |
| COMFORT-B scale for assessing pain in pediatric patients aged 0 to less than 2 years of age | Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks. | 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. |
| Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale for children aged 2 years to less than 7 years of age. | Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks. | 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. |
| Numerical Rating Scale (NRS) for assessing pain in patients aged 7 years to less than 18 years of age. | Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks. | 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. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORJan Gödeke, Dr. med.
Dr. von Hauner Children's Hospital
Outcome results
None listed