The neoClose Abdominal Closure vs Carter-Thomason Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Port Site Hernia
• Intervention / Treatment: Device: Neo Close Abdominal Closure; Device: Carter Thomason Device

Detailed Description

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
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neo Close Abdominal Closure	Device: Neo Close Abdominal Closure; Neo Close Abdominal Closure
Active Comparator: Carter Thomason Device	Device: Carter Thomason Device; Carter Thomason Device

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: NeoSurgical Limited
• Investigators: Principal Investigator: Shinil Shah, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2016
• Primary Completion (Actual): April 25, 2018
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 17, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: HSC-MS-15-0668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No