The neoClose Abdominal Closure vs Carter-Thomason Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02589171

Enrollment

Registered

2015-10-28

Start date

2016-02-12

Completion date

2018-04-25

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Port Site Hernia

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.

Interventions

DEVICENeo Close Abdominal Closure

Neo Close Abdominal Closure

DEVICECarter Thomason Device

Carter Thomason Device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively	6 weeks	Abdominal ultrasound will be used to detect port site hernia.
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site	at the time of surgery	—
Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site	at the time of surgery	—
Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site	at the time of surgery	—
Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	immediately post op	Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site	at the time of surgery	—
Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site	at the time of surgery	—

Secondary

Measure	Time frame	Description
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	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.
Pain as Assessed by Number of Participants Who Took Pain Medications	week 1	—
Hospital Stay Duration	from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)	—
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Neo Close Abdominal Closure Neo Close Abdominal Closure: Neo Close Abdominal Closure	35
Carter Thomason Device Carter Thomason Device: Carter Thomason Device	35
Total	70

Baseline characteristics

Characteristic	Neo Close Abdominal Closure	Carter Thomason Device	Total
Age, Continuous	46 years STANDARD_DEVIATION 12	45 years STANDARD_DEVIATION 11	46 years STANDARD_DEVIATION 12
Race/Ethnicity, Customized African American	6 Participants	6 Participants	12 Participants
Race/Ethnicity, Customized Caucasian	26 Participants	25 Participants	51 Participants
Race/Ethnicity, Customized Hispanic	3 Participants	4 Participants	7 Participants
Region of Enrollment United States	35 Participants	35 Participants	70 Participants
Sex: Female, Male Female	25 Participants	25 Participants	50 Participants
Sex: Female, Male Male	10 Participants	10 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 35
other Total, other adverse events	0 / 35	0 / 35
serious Total, serious adverse events	0 / 35	0 / 35

Outcome results

Primary

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

Population: Data were not available for 12 participants in the NeoClose arm and 16 participants in the Carter Thomason arm. For each participant analyzed, there were needle depth data available for 1, 2, 3, or 4 stitches per participant.

Arm	Measure	Value (MEAN)	Dispersion
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site	3.2 centimeters	Standard Deviation 0.93
Carter Thomason Device	Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site	4.9 centimeters	Standard Deviation 1.67

Primary

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.

Time frame: 6 weeks

Population: Data were not available for 1 in the Carter Thomason arm.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively	0 Participants
Carter Thomason Device	Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively	0 Participants

Primary

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.

Time frame: 1 week

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants
Carter Thomason Device	Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants

Primary

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.

Time frame: 6 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants
Carter Thomason Device	Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants

Primary

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.

Time frame: immediately post op

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants
Carter Thomason Device	Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively	0 Participants

Primary

Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site

Time frame: at the time of surgery

Population: Data were not available for 4 in the NeoClose arm and 3 in the Carter Thomason arm.

Arm	Measure	Value (MEAN)	Dispersion
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site	2 number of sutures	Standard Deviation 0
Carter Thomason Device	Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site	1.84 number of sutures	Standard Deviation 0.37

Primary

Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site

Time frame: at the time of surgery

Population: Data were not available for 5 in the NeoClose arm and 6 in the Carter Thomason arm.

Arm	Measure	Value (MEAN)	Dispersion
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site	2 number of sutures	Standard Deviation 0
Carter Thomason Device	Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site	1.83 number of sutures	Standard Deviation 0.38

Primary

Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site

Time frame: at the time of surgery

Population: Data were not available for 1 in the Carter Thomason arm.

Arm	Measure	Value (MEAN)	Dispersion
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site	20.95 seconds	Standard Deviation 11.73
Carter Thomason Device	Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site	33.23 seconds	Standard Deviation 25.89

Primary

Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site

Time frame: at the time of surgery

Population: Data were not available for 3 in the Carter Thomason arm.

Arm	Measure	Value (MEAN)	Dispersion
Neo Close Abdominal Closure	Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site	18.49 seconds	Standard Deviation 7.79
Carter Thomason Device	Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site	28.63 seconds	Standard Deviation 11.41

Secondary

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)

Arm	Measure	Value (MEAN)	Dispersion
Neo Close Abdominal Closure	Hospital Stay Duration	2.12 days	Standard Deviation 0.57
Carter Thomason Device	Hospital Stay Duration	2.12 days	Standard Deviation 0.83

Secondary

Pain as Assessed by Number of Participants Who Took Pain Medications

Time frame: week 1

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Neo Close Abdominal Closure	Pain as Assessed by Number of Participants Who Took Pain Medications	10 Participants
Carter Thomason Device	Pain as Assessed by Number of Participants Who Took Pain Medications	10 Participants

Secondary

Pain as Assessed by Number of Participants Who Took Pain Medications

Time frame: week 6

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Neo Close Abdominal Closure	Pain as Assessed by Number of Participants Who Took Pain Medications	0 Participants
Carter Thomason Device	Pain as Assessed by Number of Participants Who Took Pain Medications	1 Participants

Secondary