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

Sponsor
Duomed (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04808206
Collaborator
(none)
150
3
33
50
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Obese patients eligible for laparoscopic bariatric surgery

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  1. Device performance [At index procedure]

    Number of procedures with technical success

  2. 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.

  3. Clinical efficacy - weight loss [Follow-up 1: 1 month after the procedure]

    Weight loss

  4. Clinical efficacy - weight loss [Follow-up 2: 6 months after the procedure]

    Weight loss

  5. Clinical efficacy - weight loss [Follow-up 3: 12 months after the procedure]

    Weight loss

  6. Clinical efficacy - weight loss [Follow-up 4: 24 months after the procedure]

    Weight loss

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ziekenhuis Oost-Limburg, campus St.-Jan Genk Belgium
2 Hôpital de Nivelles, groupe Jolimont Haine-Saint-Paul Belgium
3 Ziekenhuis Maas en Kempen Maaseik Belgium

Sponsors and Collaborators

  • Duomed

Investigators

  • Principal Investigator: Marc Vertruyen, MD, Europa Ziekenhuizen (campus St.-Michiel), Etterbeek, Belgium
  • Principal Investigator: Salvatore Lobue, MD, Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duomed
ClinicalTrials.gov Identifier:
NCT04808206
Other Study ID Numbers:
  • DM-PRO-ST2021
First Posted:
Mar 22, 2021
Last Update Posted:
Jun 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 23, 2022