An observational study in Obesity and Roux-en-Y Gastric Bypass, sponsored by Duomed. Withdrawn at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Duomed · Observational
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.
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Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery. This registry will collect data from 150 laparoscopic RYGB procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.
Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
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.
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.
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
Plan to share: No
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This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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