Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01549925
First received: March 6, 2012
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: October 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epithelial Ovarian Cancer
Interventions: Other: Standard Surgical resection
Device: LIGASURE

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Surgical Resection

standard surgical resection using clamps and surgical ligatures

Standard Surgical resection: standard surgical resection using clamps and surgical ligatures

LIGASURE

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon


Participant Flow:   Overall Study
    Standard Surgical Resection     LIGASURE  
STARTED     25     25  
COMPLETED     25     25  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Surgical Resection

standard surgical resection using clamps and surgical ligatures

Standard Surgical resection: standard surgical resection using clamps and surgical ligatures

LIGASURE

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Total Total of all reporting groups

Baseline Measures
    Standard Surgical Resection     LIGASURE     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age, Customized  
[units: Participants]
     
< 50 years     1     7     8  
50-70 years     16     13     29  
>70 years     8     5     13  
Gender  
[units: participants]
     
Female     25     25     50  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Surgical Time   [ Time Frame: at time of surgery, up to 10 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mark Wade
Organization: Huntsman Cancer Institute
phone: 801-213-5746
e-mail: mark.wade@hci.utah.edu



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01549925     History of Changes
Other Study ID Numbers: HCI41380
Study First Received: March 6, 2012
Results First Received: October 2, 2015
Last Updated: December 21, 2015
Health Authority: United States: Institutional Review Board