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

NCT ID: NCT01759550

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Morbid Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Portenier, MD

Role: PRINCIPAL_INVESTIGATOR

DUMC

Locations

Duke Center for Metabolic and Weightloss Surgery

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00030546

Identifier Type: -

Identifier Source: org_study_id