Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
研究概览
简要总结
The purpose of this study is to compare the neoClose abdominal closure to the standard Carter-Thomason closure in a bariatric surgery gastric bypass population.
详细描述
Both the neoClose abdominal closure to the standard Carter-Thomason closure will be used to close 12 mm camera port sites and 12 mm stapler port sites upon completion of a robotic assisted laparoscopic gastric bypass. The procedure requires a 12 mm port site be placed in the midline approximately 3 cm cephalad to the umbilicus and a second 12mm port site in the right mid abdomen. Port sites will be closed as defined as the inability to palpate a fascial defect and the incision being air tight upon carbon dioxide insufflation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbid obesity (BMI > 35).
- •Completed multimodality pre operative evaluation (Psychology, Nutrition, Support Groups).
- •Approved for robotic assisted laparoscopic gastric bypass.
排除标准
- •Previous midline laparotomy or weight loss procedure.
研究组 & 干预措施
Neo Close Abdominal Closure
干预措施: Neo Close Abdominal Closure (Device)
Carter Thomason Device
干预措施: Carter Thomason Device (Device)
结局指标
主要结局
Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
时间窗: at the time of surgery
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
时间窗: 6 weeks
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
时间窗: at the time of surgery
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
时间窗: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
时间窗: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
时间窗: at the time of surgery
Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively
时间窗: 6 weeks
Abdominal ultrasound will be used to detect port site hernia.
次要结局
- Pain at the Stapler Port Site as Assessed by a Visual Analog Scale(6 weeks)
- Pain as Assessed by Number of Participants Who Took Pain Medications(week 6)
- Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale(6 weeks)
- Hospital Stay Duration(from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days))
研究者
Shinil Shah
Assistant Professor
The University of Texas Health Science Center, Houston