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Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04808206

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot listed
ConditionObesity, Roux-en-Y Gastric Bypass, Gastrostomy, Nissen Sleeve

Full registry criteria

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.

Treatments and study arms

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Device

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.

Primary outcomes

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)At index procedure

Number of conversions, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)At discharge up to 1 week

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)Follow-up 1: 1 month after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)Follow-up 2: 6 months after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)Follow-up 3: 12 months after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

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.

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Ziekenhuis Oost-Limburg, campus St.-Jan🇧🇪 Genk, Belgium
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Hôpital de Nivelles, groupe Jolimont🇧🇪 Haine-Saint-Paul, Belgium
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Ziekenhuis Maas en Kempen🇧🇪 Maaseik, Belgium
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