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NCT Number: NCT04808206

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

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.

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Key information

Conditions

Obesity Body Weight Gastrostomy Nissen Sleeve Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Roux-en-y Gastric Bypass Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg, campus St.-Jan, Genk, Belgium

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

    Time frame: At index procedure

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

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

    Time frame: At discharge up to 1 week

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

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

    Time frame: Follow-up 1: 1 month after the procedure

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

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

    Time frame: Follow-up 2: 6 months after the procedure

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

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

    Time frame: Follow-up 3: 12 months after the procedure

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

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

    Time frame: 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 outcomes

  1. Device performance

    Time frame: At index procedure

    Number of procedures with technical success

  2. Device performance

    Time frame: 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.

  3. Clinical efficacy - weight loss

    Time frame: Follow-up 1: 1 month after the procedure

    Weight loss

  4. Clinical efficacy - weight loss

    Time frame: Follow-up 2: 6 months after the procedure

    Weight loss

  5. Clinical efficacy - weight loss

    Time frame: Follow-up 3: 12 months after the procedure

    Weight loss

  6. Clinical efficacy - weight loss

    Time frame: Follow-up 4: 24 months after the procedure

    Weight loss

  7. Number of participants with a post-operative change of cormorbidities

    Time frame: Follow-up 3: 12 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) 12 months after the surgical procedure as compared to the patients' comorbidities at baseline.

  8. Number of participants with a post-operative change of cormorbidities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Registry information

Official study title

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

Acronym: STAP-JOLI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2021
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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