The neoClose Abdominal Closure vs Carter-Thomason Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer

Conditions
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Surgical Port Site Hernia

Intervention / Treatment
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* Device: Neo Close Abdominal Closure
* Device: Carter Thomason Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbid obesity (BMI > 35). Completed multimodality pre operative evaluation (Psychology, Nutrition, Support Groups). Approved for robotic assisted laparoscopic gastric bypass. Exclusion Criteria: Previous midline laparotomy or weight loss procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neo Close Abdominal Closure<br> | Device: Neo Close Abdominal Closure<br>* Neo Close Abdominal Closure<br>|
| Active Comparator: Carter Thomason Device<br> | Device: Carter Thomason Device<br>* Carter Thomason Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site |  | at the time of surgery | 
| Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site |  | at the time of surgery | 
| Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site |  | at the time of surgery | 
| Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site |  | 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 |  | 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. | 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. | 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. | 6 weeks | 
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 6 weeks | 
| Pain as Assessed by Number of Participants Who Took Pain Medications |  | week 1 | 
| Pain as Assessed by Number of Participants Who Took Pain Medications |  | week 6 | 
| Hospital Stay Duration |  | from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days) |