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The neoClose Abdominal Closure vs Carter-Thomason Trial

Primary Purpose

Surgical Port Site Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neo Close Abdominal Closure
Carter Thomason Device
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Port Site Hernia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neo Close Abdominal Closure

Carter Thomason Device

Arm Description

Outcomes

Primary Outcome Measures

Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Pain as Assessed by Number of Participants Who Took Pain Medications
Pain as Assessed by Number of Participants Who Took Pain Medications
Hospital Stay Duration

Full Information

First Posted
October 20, 2015
Last Updated
August 17, 2019
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
NeoSurgical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02589171
Brief Title
The neoClose Abdominal Closure vs Carter-Thomason Trial
Official Title
Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2016 (Actual)
Primary Completion Date
April 25, 2018 (Actual)
Study Completion Date
April 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
NeoSurgical Limited

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Port Site Hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neo Close Abdominal Closure
Arm Type
Experimental
Arm Title
Carter Thomason Device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Neo Close Abdominal Closure
Intervention Description
Neo Close Abdominal Closure
Intervention Type
Device
Intervention Name(s)
Carter Thomason Device
Intervention Description
Carter Thomason Device
Primary Outcome Measure Information:
Title
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
Time Frame
at the time of surgery
Title
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
Time Frame
at the time of surgery
Title
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
Time Frame
at the time of surgery
Title
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
Time Frame
at the time of surgery
Title
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
Title
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Description
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Time Frame
immediately post op
Title
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Description
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Time Frame
1 week
Title
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Description
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Time Frame
6 weeks
Title
Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively
Description
Abdominal ultrasound will be used to detect port site hernia.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Description
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
Title
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Description
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
Title
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Description
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
Title
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Description
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
Title
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Description
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
Title
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Description
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
Title
Pain as Assessed by Number of Participants Who Took Pain Medications
Time Frame
week 1
Title
Pain as Assessed by Number of Participants Who Took Pain Medications
Time Frame
week 6
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinil Shah, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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The neoClose Abdominal Closure vs Carter-Thomason Trial

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