A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy (STAP-JOLI)

A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy

The purpose of this observational registry is to evaluate the safety and the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical). The goal of the study will be achieved by reporting peri- and postoperative complications and the clinical outcome after surgery in a prospectively maintained database.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Stephanie De Munter, PhD; Phone Number: +32 (0)11 28 69 48; Email: stephanie.de.munter@archerresearch.eu

Study Locations

• Belgium
  • Genk, Belgium
    • Not yet recruiting
    • Ziekenhuis Oost-Limburg, Campus St.-Jan
    • Contact: Hans Verhelst, MD
  • Haine-Saint-Paul, Belgium
    • Not yet recruiting
    • Hôpital de Nivelles, groupe Jolimont
    • Contact: Salvatore Lobue, MD
  • Maaseik, Belgium
    • Recruiting
    • Ziekenhuis Maas en Kempen
    • Contact: Hans Verhelst, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data from 250 laparoscopic bariatric 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 registry 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-morbidities.
• Patient has a BMI ≥ 40 kg/m2.
• Patient is eligible for laparoscopic bariatric 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 registry protocol or the proposed follow-up visits.
• Patient has a contra-indication for laparoscopic bariatric 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 eligible for laparoscopic bariatric surgery	Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical); Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for the creation of anastomoses during laparoscopic bariatric surgery manufactured by Ezisurg Medical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)	Number of conversions, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.	At index procedure
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)	Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.	At discharge up to 1 week
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)	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 of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)	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 of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)	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 of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)	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
Device performance	Number of procedures with technical success	At index procedure
Device performance	Scoring of: easy of intra-abdominal device positioning, grasping/climbing force, sharpness of the blades, staple-line formation, device stability, device maneuverability, 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
Clinical efficacy - weight loss	Weight loss	Follow-up 1: 1 month after the procedure
Clinical efficacy - weight loss	Weight loss	Follow-up 2: 6 months after the procedure
Clinical efficacy - weight loss	Weight loss	Follow-up 3: 12 months after the procedure
Clinical efficacy - weight loss	Weight loss	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.	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

Collaborators and Investigators

• Sponsor: Duomed
• Investigators: Principal Investigator: Marc Vertruyen, MD, Europa Ziekenhuizen (campus St.-Michiel), Etterbeek, Belgium; Principal Investigator: Salvatore Lobue, MD, Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DM-PRO-ST2021

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