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

NCT04543526 | Withdrawn

• 1 other identifier: DM-ZOL-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Roux-en-Y Gastric Bypass

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (15)

• Device performance - Technical success of the surgical procedure performed with the device

  At index procedure

• Device performance - Scoring of operator satisfaction

  At index procedure

• Post-operative pain by means of the Visual Analogue Scale (VAS)

  At index procedure

• Post-operative pain by means of the Visual Analogue Scale (VAS)

  At discharge, up to 1 week

• Post-operative pain by means of the Visual Analogue Scale (VAS)

  Follow-up 1: 1 month after the procedure

Study Arms (1)

Obese patients

Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.

Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Interventions

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) DEVICE

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.

Obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duomed: lead

Study Sites (2)

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

Location

Ziekenhuis Maas en Kempen (ZMK)

Maaseik, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Verhelst, Dr.

  Ziekenhuis Oost-Limburg (ZOL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2021
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: January 11, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)