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

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Duke University

Status

Terminated

Conditions

Morbid Obesity

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01759550
Pro00030546

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

51 participants in 1 patient group

LigaSure Device
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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