The neoClose Abdominal Closure vs Carter-Thomason Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-12

Study Completion Date

2018-04-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Port Site Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Neo Close Abdominal Closure

Group Type EXPERIMENTAL

Neo Close Abdominal Closure

Intervention Type DEVICE

Neo Close Abdominal Closure

Carter Thomason Device

Group Type ACTIVE_COMPARATOR

Carter Thomason Device

Intervention Type DEVICE

Carter Thomason Device

Interventions

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Neo Close Abdominal Closure

Intervention Type DEVICE

Carter Thomason Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Morbid obesity (BMI \> 35).
* Completed multimodality pre operative evaluation (Psychology, Nutrition, Support Groups).
* Approved for robotic assisted laparoscopic gastric bypass.