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

Active, not recruiting

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

• Registration Number: NCT04808206
• Lead Sponsor: Duomed

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Study Start: 2022-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients eligible for laparoscopic bariatric surgery	easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	-

Primary Outcome Measures

Name	Time	Method
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)	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

Name	Time	Method
Clinical efficacy - weight loss	Follow-up 4: 24 months after the procedure	Weight loss
Device performance	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, 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.
Number of participants with a post-operative change of cormorbidities	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.

Trial Locations

Locations (3)

Ziekenhuis Oost-Limburg, campus St.-Jan; 🇧🇪 Genk, Belgium

Hôpital de Nivelles, groupe Jolimont; 🇧🇪 Haine-Saint-Paul, Belgium

Ziekenhuis Maas en Kempen; 🇧🇪 Maaseik, Belgium