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)

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 Overview

• Status: Withdrawn
• Conditions: Obesity; Roux-en-Y Gastric Bypass
• Intervention / Treatment: Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

• Study Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg (ZOL)
  • Maaseik, Belgium
    • Ziekenhuis Maas en Kempen (ZMK)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Conversion rate to laparotomy	Number of conversions to laparotomy during the index procedure	At index procedure.
Safety - Length of stay at the intensive care unit	Number of days at the intensive care unit after the index procedure.	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.	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.	At index procedure.
Safety - Length of stay at the intensive care unit.	Number of days at the intensive care unit after the index procedure.	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.	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.	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.	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.	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.	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.	Follow-up 4: 24 months after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Follow-up 4: 24 months after the procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DM-ZOL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No