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

This study has been terminated.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01759550
First received: December 31, 2012
Last updated: August 5, 2014
Last verified: August 2014
  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:


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 Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
LigaSure Device
In this prospective observational study, 60 patients scheduled to undergo a Roux-en-Y or gastric reduction procedure (sleeve gastrectomy or plication) will have hemostasis controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. Both devices are regularly used at Duke in the Bariatric Surgery division. The surgeon will select which device is used. There will be no randomization. The device decision tree will be based upon the procedure. Cases that require enterotomy will utilize the AdvanceTM pistol grip. Cases which don't need enterotomy will utilize the 5 Blunt Tip. The LigaSure AdvanceTM pistol grip and LigaSureTM Blunt Tip are used exclusively with the Force TriadTM Energy platform. There is no simultaneous use.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 5, 2014
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, Morbid
Body Weight
Nutrition Disorders
Obesity
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014