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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Duomed
- 试验地点
- 2
- 主要终点
- Safety - Length of stay at the intensive care unit.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB surgery.
排除标准
- •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.
结局指标
主要结局
Safety - Length of stay at the intensive care unit.
时间窗: At discharge, up to 1 week.
Number of days at the intensive care unit after the index procedure.
Safety - Number of re-interventions and number of participants with (serious) adverse events
时间窗: Follow-up 4: 24 months after the procedure.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety - Length of stay at the intensive care unit
时间窗: At index procedure.
Number of days at the intensive care unit after the index procedure.
Safety - Conversion rate to laparotomy
时间窗: At index procedure.
Number of conversions to laparotomy during the index procedure
Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
时间窗: At discharge, up to 1 week.
he Modified PADSS guarantees safe discharge. PADSS is based on the assessment of 6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output. Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for discharge, provided that the score for vital signs is not lower than 2 and that none of the other five criteria is 0, even if the total score reaches 9.
次要结局
- Post-operative change in weight(Follow-up 4: 24 months after the procedure)
- Number of participants with a post-operative change of cormorbidities(Follow-up 4: 24 months after the procedure)
- Device performance - Technical success of the surgical procedure performed with the device(At index procedure)
- Post-operative food tolerance by means of the food tolerance questionnaire(Follow-up 4: 24 months after the procedure)
- Device performance - Scoring of operator satisfaction(At index procedure)
- Post-operative pain by means of the Visual Analogue Scale (VAS)(Follow-up 1: 1 month after the procedure)