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Completed

NCT Number: NCT02589171

The neoClose Abdominal Closure vs Carter-Thomason Trial

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.

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Key information

Conditions

Surgical Port Site Hernia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neo Close Abdominal Closure

Device

Neo Close Abdominal Closure

Carter Thomason Device

Device

Carter Thomason Device

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • NeoSurgical Limited

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2015
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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