The neoClose Abdominal Closure vs Carter-Thomason Trial

Not Applicable

Completed

• Conditions: Surgical Port Site Hernia
• Interventions: Device: Neo Close Abdominal Closure; Device: Carter Thomason Device

• Registration Number: NCT02589171
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2016-02-12
• Primary Completion: 2018-04-25
• Study Completion: 2018-04-25
• Results First Submitted: 2019-07-26
• Results First Submitted QC: 2019-07-26
• Status Verified: 2019-08
• Results First Posted: 2019-08-15
• Last Update Submitted: 2019-08-17
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neo Close Abdominal Closure	Neo Close Abdominal Closure	-
Carter Thomason Device	Carter Thomason Device	-

Primary Outcome Measures

Name	Time	Method
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
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 the Time Required to Complete Closure at the Camera Port Site	at the time of surgery
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 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	6 weeks	Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.

Secondary Outcome Measures

Name	Time	Method
Pain at the Stapler Port Site as Assessed by a Visual Analog Scale	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.
Pain as Assessed by Number of Participants Who Took Pain Medications	week 6
Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale	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.
Hospital Stay Duration	from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States