Clinical trial NCT04808206: A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
Official title: A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Roux-en-Y Gastric Bypass
Gastrostomy
Nissen Sleeve
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
timeFrame: At index procedure
measure: Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
timeFrame: At discharge up to 1 week
measure: Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
timeFrame: Follow-up 1: 1 month after the procedure
measure: Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
timeFrame: Follow-up 2: 6 months after the procedure
measure: Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
timeFrame: Follow-up 3: 12 months after the procedure
measure: Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
timeFrame: Follow-up 4: 24 months after the procedure
Secondary outcomes:
measure: Device performance
timeFrame: At index procedure
measure: Device performance
timeFrame: At index procedure
measure: Clinical efficacy - weight loss
timeFrame: Follow-up 1: 1 month after the procedure
measure: Clinical efficacy - weight loss
timeFrame: Follow-up 2: 6 months after the procedure
measure: Clinical efficacy - weight loss
timeFrame: Follow-up 3: 12 months after the procedure
measure: Clinical efficacy - weight loss
timeFrame: Follow-up 4: 24 months after the procedure
measure: Number of participants with a post-operative change of cormorbidities
timeFrame: Follow-up 3: 12 months after the procedure
measure: Number of participants with a post-operative change of cormorbidities
timeFrame: Follow-up 4: 24 months after the procedure
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg, campus St.-Jan
city: Haine-Saint-Paul
country: Belgium
facility: Hôpital de Nivelles, groupe Jolimont
city: Maaseik
country: Belgium
facility: Ziekenhuis Maas en Kempen
Study officials:
affiliation: Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium
name: Salvatore Lobue, MD
role: PRINCIPAL_INVESTIGATOR
References: