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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
Last Update Posted : October 11, 2018
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 closurewill be used to close 12 mm camera and stapler port sites upon completion of a robotic assisted laparoscopic gastric bypass. The procedure requires a 12 mm port be placed in the midline approximately 3 cm cephalad to the umbilicus and a second 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  (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 : June 2018
Actual Study Completion Date : June 2018

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 [ Time Frame: at the time of surgery ]
  2. Technical effectiveness as assessed by the time required to complete closure [ Time Frame: at the time of surgery ]
  3. Technical effectiveness as assessed by depth of needle penetration to complete closure [ Time Frame: at the time of surgery ]
  4. Technical effectiveness as assessed by surgical site occurrences [ Time Frame: immediately post op ]
    Surgical site occurrences include hernia and infection.

  5. Technical effectiveness as assessed by surgical site occurrences [ Time Frame: 1 week ]
    Surgical site occurrences include hernia and infection.

  6. Technical effectiveness as assessed by surgical site occurrences [ Time Frame: 6 weeks ]
    Surgical site occurrences include hernia and infection.

  7. Technical effectiveness as assessed by presence of port site hernia [ Time Frame: 6 weeks ]
    Abdominal ultrasound will be used to detect port site hernia.


Secondary Outcome Measures :
  1. Pain as assessed by a visual analog scale at the 12mm camera port site [ Time Frame: immediately after surgery ]
  2. Pain as assessed by a visual analog scale at the 12mm camera port site [ Time Frame: 1 week ]
  3. Pain as assessed by a visual analog scale at the 12mm camera port site [ Time Frame: 6 weeks ]
  4. Pain as assessed by a visual analog scale at the stapler port site [ Time Frame: immediately after surgery ]
  5. Pain as assessed by a visual analog scale at the stapler port site [ Time Frame: 1 week ]
  6. Pain as assessed by a visual analog scale at the stapler port site [ Time Frame: 6 weeks ]
  7. Pain assessed by amount of intravenous narcotics required immediately after surgery [ Time Frame: immediately after surgery ]
  8. Pain as assessed by amount of intravenous narcotics required one day after surgery [ Time Frame: 1 day after surgery ]
  9. Pain as assessed by hospital stay duration [ Time Frame: immediately after surgery ]
  10. Pain as assessed by hospital stay duration [ Time Frame: 1 day after surgery ]


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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
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
Principal Investigator: Shinil Shah, MD The University of Texas Health Science Center, Houston

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
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes