Clinical trial NCT01759550: Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
Official title: Prospective Case-Series of LigaSure Advance Pistol Grip and LigaSure Blunt Tip in Gastric Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Morbid Obesity
Keywords: Gastric Procedures
Force Triad
LigaSure Advance Pistol Grip
LigaSure Blunt Tip
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2013-01-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include 60 patients previously scheduled to undergo a Roux-en-Y or gastric reduction precodures (sleeve gastrectomy or placation) using the LigaSure Advance Pistol Grip or LigaSure Blunt Tip, repectively. The pricipal investigator will be responsible for patient selection.

Brief summary: The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic value of using LigaSure in gastric surgeries will be appraised.

In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation) procedure at Durham Regional Hospital will be recruited.

Data Analysis will be performed using the data collected in the software program titled MetaBar at Duke University Medical Center. Categorical variables will be summarized as proportions for each category; continuous measures will be summarized by mean and standard deviation or median and range as appropriated for the data distribution. Procedure-related risks are those typically associated with gastric procedures and general anesthesia including intra-operative bleeding, infection, and injury to surrounding organs and structures. Device related risks include those normally associated with the use of electrosurgery including intra-operative bleeding, unintended tissue burns, electrical shock, and electrical stimulation of muscles and nerves.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Patients who will undergo a Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation)
* Patients with a BMI between 40-60

Exclusion Criteria:

* Patients under 18 years of age
* Patients participating in other competing research protocol(s)
* Patients for whom electrosurgery is contraindicated
* Patients unable to tolerate general anesthesia
* Patients who are pregnant
* Patients unwilling or unable to provide informed consent
* Patients who have undergone significant upper GI surgery leading to adhesion formation, as determined by the Principal Investigator.

Primary outcomes:
measure: Safety and Efficacy of the LigaSure Advance Pistol Grip and LigaSure Blunt Tip using the Force Triad Energy Platform during Roux-en-Y and gastric reduction procedures.
timeFrame: 1 month
Secondary outcomes:
measure: Economic value of using LigaSure in gastric surgeries
timeFrame: 1 month
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Metabolic and Weightloss Surgery
state: North Carolina
Study officials:
affiliation: DUMC
name: Dana Portenier, MD
role: PRINCIPAL_INVESTIGATOR
References: