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

Duomed

Status: Active, not recruiting

Conditions: Gastrostomy; Obesity; Roux-en-Y Gastric Bypass; Nissen Sleeve

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04808206

DM-PRO-ST2021

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Obese patients eligible for laparoscopic bariatric surgery

Treatment:

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