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

Obesity Clinical Trial

— STAP-JOLI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808206
• Other study ID #: DM-PRO-ST2021
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2023
• Source: Duomed
• Contact: Stephanie De Munter, PhD
• Phone: +32 (0)11 28 69 48
• Email: stephanie.de.munter[@]archerresearch.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2025
• Est. primary completion date: January 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrostomy
• Nissen Sleeve
• Obesity
• Roux-en-Y Gastric Bypass

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg, campus St.-Jan	Genk
Belgium	Hôpital de Nivelles, groupe Jolimont	Haine-Saint-Paul
Belgium	Ziekenhuis Maas en Kempen	Maaseik

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Device performance	Number of procedures with technical success	At index procedure
Secondary	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
Secondary	Clinical efficacy - weight loss	Weight loss	Follow-up 1: 1 month after the procedure
Secondary	Clinical efficacy - weight loss	Weight loss	Follow-up 2: 6 months after the procedure
Secondary	Clinical efficacy - weight loss	Weight loss	Follow-up 3: 12 months after the procedure
Secondary	Clinical efficacy - weight loss	Weight loss	Follow-up 4: 24 months after the procedure
Secondary	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
Secondary	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