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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01549925
Recruitment Status : Completed
First Posted : March 9, 2012
Results First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Epithelial Ovarian Cancer
Interventions: Other: Standard Surgical resection
Device: LIGASURE

  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

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 
Overall Participants Analyzed 
[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

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

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
First Submitted: March 6, 2012
First Posted: March 9, 2012
Results First Submitted: October 2, 2015
Results First Posted: January 28, 2016
Last Update Posted: January 28, 2016