The neoClose Abdominal Closure vs Carter-Thomason Trial

Surgical Port Site Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589171
• Other study ID #: HSC-MS-15-0668
• Status: Completed
• Phase: N/A
• Start date: February 12, 2016
• Est. completion date: April 25, 2018

Study information

• Verified date: August 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 25, 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Surgical Port Site Hernia

Intervention

Device:
• Neo Close Abdominal Closure
Neo Close Abdominal Closure
• Carter Thomason Device
Carter Thomason Device

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	NeoSurgical Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site		at the time of surgery
Primary	Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site		at the time of surgery
Primary	Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site		at the time of surgery
Primary	Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site		at the time of surgery
Primary	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
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.	immediately post op
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.	1 week
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.	6 weeks
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.	6 weeks
Secondary	Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	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.	day 1
Secondary	Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	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.	1 week
Secondary	Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	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 weeks
Secondary	Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	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.	day 1
Secondary	Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	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.	1 week
Secondary	Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	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 weeks
Secondary	Pain as Assessed by Number of Participants Who Took Pain Medications		week 1
Secondary	Pain as Assessed by Number of Participants Who Took Pain Medications		week 6
Secondary	Hospital Stay Duration		from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)