The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.
Study Type
OBSERVATIONAL
Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical.
Ziekenhuis Oost-Limburg (ZOL)
Genk, Belgium
Ziekenhuis Maas en Kempen (ZMK)
Maaseik, Belgium
Safety - Conversion rate to laparotomy
Number of conversions to laparotomy during the index procedure
Time frame: At index procedure.
Safety - Length of stay at the intensive care unit
Number of days at the intensive care unit after the index procedure.
Time frame: At index procedure.
Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
The Modified PADSS guarantees safe discharge. PADSS is based on the assessment of 6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output. Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for discharge, provided that the score for vital signs is not lower than 2 and that none of the other five criteria is 0, even if the total score reaches 9.
Time frame: At index procedure.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: At index procedure.
Safety - Length of stay at the intensive care unit.
Number of days at the intensive care unit after the index procedure.
Time frame: At discharge, up to 1 week.
Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
he Modified PADSS guarantees safe discharge. PADSS is based on the assessment of 6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output. Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for discharge, provided that the score for vital signs is not lower than 2 and that none of the other five criteria is 0, even if the total score reaches 9.
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Time frame: At discharge, up to 1 week.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: At discharge, up to 1 week.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 1: 1 month after the procedure.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 2: 6 months after the procedure.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 3: 12 months after the procedure
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 4: 24 months after the procedure.
Device performance - Technical success of the surgical procedure performed with the device
Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to laparotomy.
Time frame: At index procedure
Device performance - Scoring of operator satisfaction
Scoring of: easy of intra-abdominal device positioning, grasping/climbing force, sharpness of the blades, staple-line formation, device stability, device maneuverability, battery power, device consistency and reliability, ergonomic design, hemostasis. Each of the aforementioned items receives a score from 0 to 4, with 0 indicating that the user is very unsatisfied and 4 indicating that the user is very satisfied.
Time frame: At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Assessment of acute post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Time frame: At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Assessment of acute post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Time frame: At discharge, up to 1 week
Post-operative pain by means of the Visual Analogue Scale (VAS)
Assessment of the worst post-operative abdominal pain since discharge by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Time frame: Follow-up 1: 1 month after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Time frame: Follow-up 1: 1 month after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Time frame: Follow-up 2: 6 months after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Time frame: Follow-up 3: 12 months after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Time frame: Follow-up 4: 24 months after the procedure
Post-operative change in weight
Weight loss 1 month after the surgical procedure as compared to the patients' weight at baseline.
Time frame: Follow-up 1: 1 month after the procedure
Post-operative change in weight
Weight loss 6 months after the surgical procedure as compared to the patients' weight at baseline.
Time frame: Follow-up 2: 6 months after the procedure
Post-operative change in weight
Weight loss 12 months after the surgical procedure as compared to the patients' weight at baseline.
Time frame: Follow-up 3: 12 months after the procedure
Post-operative change in weight
Weight loss 24 months after the surgical procedure as compared to the patients' weight at baseline.
Time frame: Follow-up 4: 24 months after the procedure
Number of participants with a post-operative change of cormorbidities
Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 12 months after the surgical procedure as compared to the patients' comorbidities at baseline.
Time frame: Follow-up 3: 12 months after the procedure
Number of participants with a post-operative change of cormorbidities
Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 24 months after the surgical procedure as compared to the patients' comorbidities at baseline.
Time frame: Follow-up 4: 24 months after the procedure