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Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01759550
First received: December 31, 2012
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Case-Series of LigaSure Advance Pistol Grip and LigaSure Blunt Tip in Gastric Procedures

Resource links provided by NLM:

MedlinePlus related topics: Flu Obesity
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Primary study variables include patient demographic information (age, pre- and post-operative BMI, gender, and presence of obesity associated co-morbid disease conditions such as hypertension, diabetes, sleep apnea, obesity hypoventilation, heart failure, prior blood clots, etc.), procedure time, American Society of Anesthesiologists (ASA) score, operative blood loss,length of hospital stay, and any complications noted up to one month post-operative.


Secondary Outcome Measures:
  • Economic value of using LigaSure in gastric surgeries [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    These variables include the costs of the instrument, duration and costs of anesthesia, postoperative analgesic use, and hospital day rate costs to study the economic impact of different hemostatic devices and observe trends towards cost differences. Outcomes such as perceived ergonomics, multi-functionality, and access to organs will be collected.


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759550

Locations
United States, North Carolina
Duke Center for Metabolic and Weightloss Surgery
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University
Covidien
Investigators
Principal Investigator: Dana Portenier, MD DUMC
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01759550     History of Changes
Other Study ID Numbers: Pro00030546
Study First Received: December 31, 2012
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Gastric Procedures
Force Triad
LigaSure Advance Pistol Grip
LigaSure Blunt Tip

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013