Clinical trial NCT02589171: 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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Port Site Hernia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: NeoSurgical Limited
First posted: 2015-10-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
timeFrame: at the time of surgery
measure: Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
timeFrame: at the time of surgery
measure: Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
timeFrame: at the time of surgery
measure: Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
timeFrame: at the time of surgery
measure: Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
timeFrame: at the time of surgery
measure: Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
timeFrame: immediately post op
measure: Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
timeFrame: 1 week
measure: Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
timeFrame: 6 weeks
measure: Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
timeFrame: day 1
measure: Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
timeFrame: 1 week
measure: Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
timeFrame: 6 weeks
measure: Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
timeFrame: day 1
measure: Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
timeFrame: 1 week
measure: Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
timeFrame: 6 weeks
measure: Pain as Assessed by Number of Participants Who Took Pain Medications
timeFrame: week 1
measure: Pain as Assessed by Number of Participants Who Took Pain Medications
timeFrame: week 6
measure: Hospital Stay Duration
timeFrame: from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shinil Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: