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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
70
Neo Close Abdominal Closure
Carter Thomason Device
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
Time frame: at the time of surgery
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Time frame: immediately post op
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Time frame: 1 week
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Time frame: 6 weeks
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Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively
Abdominal ultrasound will be used to detect port site hernia.
Time frame: 6 weeks
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Time frame: day 1
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Time frame: 1 week
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Time frame: 6 weeks
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Time frame: day 1
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Time frame: 1 week
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Time frame: 6 weeks
Pain as Assessed by Number of Participants Who Took Pain Medications
Time frame: week 1
Pain as Assessed by Number of Participants Who Took Pain Medications
Time frame: week 6
Hospital Stay Duration
Time frame: from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)