Clinical trial NCT04543526: A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
Official title: A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Roux-en-Y Gastric Bypass
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery. This registry will collect data from 150 laparoscopic RYGB procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).

Brief summary: The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years of age at study 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-morbidity.
* Patient has a BMI ≥ 40 kg/m2.
* Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB 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 study protocol or proposed follow-up visits.
* Patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.

Primary outcomes:
measure: Safety - Conversion rate to laparotomy
timeFrame: At index procedure.
measure: Safety - Length of stay at the intensive care unit
timeFrame: At index procedure.
measure: Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
timeFrame: At index procedure.
measure: Safety - Number of re-interventions and number of participants with (serious) adverse events
timeFrame: At index procedure.
measure: Safety - Length of stay at the intensive care unit.
timeFrame: At discharge, up to 1 week.
measure: Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
timeFrame: At discharge, up to 1 week.
measure: Safety - Number of re-interventions and number of participants with (serious) adverse events
timeFrame: At discharge, up to 1 week.
measure: Safety - Number of re-interventions and number of participants with (serious) adverse events
timeFrame: Follow-up 1: 1 month after the procedure.
measure: Safety - Number of re-interventions and number of participants with (serious) adverse events
timeFrame: Follow-up 2: 6 months after the procedure.
measure: Safety - Number of re-interventions and number of participants with (serious) adverse events
timeFrame: Follow-up 3: 12 months after the procedure
measure: Safety - Number of re-interventions and number of participants with (serious) adverse events
timeFrame: Follow-up 4: 24 months after the procedure.
Secondary outcomes:
measure: Device performance - Technical success of the surgical procedure performed with the device
timeFrame: At index procedure
measure: Device performance - Scoring of operator satisfaction
timeFrame: At index procedure
measure: Post-operative pain by means of the Visual Analogue Scale (VAS)
timeFrame: At index procedure
measure: Post-operative pain by means of the Visual Analogue Scale (VAS)
timeFrame: At discharge, up to 1 week
measure: Post-operative pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 1: 1 month after the procedure
measure: Post-operative food tolerance by means of the food tolerance questionnaire
timeFrame: Follow-up 1: 1 month after the procedure
measure: Post-operative food tolerance by means of the food tolerance questionnaire
timeFrame: Follow-up 2: 6 months after the procedure
measure: Post-operative food tolerance by means of the food tolerance questionnaire
timeFrame: Follow-up 3: 12 months after the procedure
measure: Post-operative food tolerance by means of the food tolerance questionnaire
timeFrame: Follow-up 4: 24 months after the procedure
measure: Post-operative change in weight
timeFrame: Follow-up 1: 1 month after the procedure
measure: Post-operative change in weight
timeFrame: Follow-up 2: 6 months after the procedure
measure: Post-operative change in weight
timeFrame: Follow-up 3: 12 months after the procedure
measure: Post-operative change in weight
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 (ZOL)
city: Maaseik
country: Belgium
facility: Ziekenhuis Maas en Kempen (ZMK)
Study officials:
affiliation: Ziekenhuis Oost-Limburg (ZOL)
name: Hans Verhelst, Dr.
role: PRINCIPAL_INVESTIGATOR
References: