A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery (SIRIUS)

• ClinicalTrials.gov Identifier: NCT04543526
• Recruitment Status: Withdrawn
• First Posted: September 10, 2020
• Last Update Posted: January 11, 2022
• Sponsor: Duomed
• Information provided by (Responsible Party): Duomed

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Obesity; Roux-en-Y Gastric Bypass	Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
• Estimated Study Start Date: September 1, 2021
• Estimated Primary Completion Date: October 31, 2024
• Estimated Study Completion Date: November 30, 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Obese patients; 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.

Outcome Measures

Primary Outcome Measures :

1. Safety - Conversion rate to laparotomy [ Time Frame: At index procedure. ]
   Number of conversions to laparotomy during the index procedure
2. Safety - Length of stay at the intensive care unit [ Time Frame: At index procedure. ]
   Number of days at the intensive care unit after the index procedure.
3. Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS) [ Time Frame: At index procedure. ]
   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.
4. Safety - Number of re-interventions and number of participants with (serious) adverse events [ Time Frame: At index procedure. ]
   Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
5. Safety - Length of stay at the intensive care unit. [ Time Frame: At discharge, up to 1 week. ]
   Number of days at the intensive care unit after the index procedure.
6. Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS) [ Time Frame: At discharge, up to 1 week. ]
   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.
7. Safety - Number of re-interventions and number of participants with (serious) adverse events [ Time Frame: At discharge, up to 1 week. ]
   Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
8. Safety - Number of re-interventions and number of participants with (serious) adverse events [ Time Frame: Follow-up 1: 1 month after the procedure. ]
   Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
9. Safety - Number of re-interventions and number of participants with (serious) adverse events [ Time Frame: Follow-up 2: 6 months after the procedure. ]
   Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
10. Safety - Number of re-interventions and number of participants with (serious) adverse events [ Time Frame: Follow-up 3: 12 months after the procedure ]
    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
11. Safety - Number of re-interventions and number of participants with (serious) adverse events [ Time Frame: Follow-up 4: 24 months after the procedure. ]
    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Secondary Outcome Measures :

1. Device performance - Technical success of the surgical procedure performed with the device [ Time Frame: At index procedure ]
   Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to laparotomy.
2. Device performance - Scoring of operator satisfaction [ Time Frame: At index procedure ]
   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.
3. Post-operative pain by means of the Visual Analogue Scale (VAS) [ Time Frame: At index procedure ]
   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.
4. Post-operative pain by means of the Visual Analogue Scale (VAS) [ Time Frame: At discharge, up to 1 week ]
   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.
5. Post-operative pain by means of the Visual Analogue Scale (VAS) [ Time Frame: Follow-up 1: 1 month after the procedure ]
   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.
6. Post-operative food tolerance by means of the food tolerance questionnaire [ Time Frame: Follow-up 1: 1 month after the procedure ]
   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.
7. Post-operative food tolerance by means of the food tolerance questionnaire [ Time Frame: Follow-up 2: 6 months after the procedure ]
   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.
8. Post-operative food tolerance by means of the food tolerance questionnaire [ Time Frame: Follow-up 3: 12 months after the procedure ]
   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.
9. Post-operative food tolerance by means of the food tolerance questionnaire [ Time Frame: Follow-up 4: 24 months after the procedure ]
   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.
10. Post-operative change in weight [ Time Frame: Follow-up 1: 1 month after the procedure ]
    Weight loss 1 month after the surgical procedure as compared to the patients' weight at baseline.
11. Post-operative change in weight [ Time Frame: Follow-up 2: 6 months after the procedure ]
    Weight loss 6 months after the surgical procedure as compared to the patients' weight at baseline.
12. Post-operative change in weight [ Time Frame: Follow-up 3: 12 months after the procedure ]
    Weight loss 12 months after the surgical procedure as compared to the patients' weight at baseline.
13. Post-operative change in weight [ Time Frame: Follow-up 4: 24 months after the procedure ]
    Weight loss 24 months after the surgical procedure as compared to the patients' weight at baseline.
14. Number of participants with a post-operative change of cormorbidities [ Time Frame: Follow-up 3: 12 months after the procedure ]
    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.
15. Number of participants with a post-operative change of cormorbidities [ Time Frame: Follow-up 4: 24 months after the procedure ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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).

Criteria

Inclusion Criteria:

• Patient ≥ 18 years of age at study entry.
• Patient and investigator signed and dated the informed consent form prior to the index-procedure.
• Patient has a BMI ≥ 35 kg/m2 with one or more related co-morbidity.
• Patient has a BMI ≥ 40 kg/m2.
• Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB surgery.

Exclusion Criteria:

• Patient is unable / unwilling to provide informed consent.
• Patient has a history of bariatric surgery.
• Patient is unable to comply with the study protocol or proposed follow-up visits.
• Patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.

Contacts and Locations

Locations

Belgium

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

Ziekenhuis Maas en Kempen (ZMK)

Maaseik, Belgium

Sponsors and Collaborators

Duomed

Investigators

• Principal Investigator: Hans Verhelst, Dr.; Ziekenhuis Oost-Limburg (ZOL)

More Information

• Responsible Party: Duomed
• ClinicalTrials.gov Identifier: NCT04543526
• Other Study ID Numbers: DM-ZOL-01
• First Posted: September 10, 2020
• Last Update Posted: January 11, 2022
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No