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The neoClose Abdominal Closure vs Carter-Thomason Trial

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ClinicalTrials.gov Identifier: NCT02589171
Recruitment Status : Completed
First Posted : October 28, 2015
Results First Posted : August 15, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
NeoSurgical Limited
Information provided by (Responsible Party):
Shinil Shah, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Surgical Port Site Hernia Device: Neo Close Abdominal Closure Device: Carter Thomason Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer
Actual Study Start Date : February 12, 2016
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site [ Time Frame: at the time of surgery ]
  2. Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site [ Time Frame: at the time of surgery ]
  3. Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site [ Time Frame: at the time of surgery ]
  4. Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site [ Time Frame: at the time of surgery ]
  5. 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 ]
  6. Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively [ Time Frame: immediately post op ]
    Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.

  7. Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively [ Time Frame: 1 week ]
    Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.

  8. Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively [ Time Frame: 6 weeks ]
    Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.

  9. Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively [ Time Frame: 6 weeks ]
    Abdominal ultrasound will be used to detect port site hernia.


Secondary Outcome Measures :
  1. Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale [ Time Frame: day 1 ]
    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.

  2. Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale [ Time Frame: 1 week ]
    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.

  3. Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale [ Time Frame: 6 weeks ]
    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.

  4. Pain at the Stapler Port Site as Assessed by a Visual Analog Scale [ Time Frame: day 1 ]
    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.

  5. Pain at the Stapler Port Site as Assessed by a Visual Analog Scale [ Time Frame: 1 week ]
    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. Pain at the Stapler Port Site as Assessed by a Visual Analog Scale [ Time Frame: 6 weeks ]
    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.

  7. Pain as Assessed by Number of Participants Who Took Pain Medications [ Time Frame: week 1 ]
  8. Pain as Assessed by Number of Participants Who Took Pain Medications [ Time Frame: week 6 ]
  9. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589171


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
NeoSurgical Limited
Investigators
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Principal Investigator: Shinil Shah, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Shinil Shah, The University of Texas Health Science Center, Houston:

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Responsible Party: Shinil Shah, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02589171     History of Changes
Other Study ID Numbers: HSC-MS-15-0668
First Posted: October 28, 2015    Key Record Dates
Results First Posted: August 15, 2019
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical