Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery

This study has been completed.
Sponsor:
Collaborator:
Tyco Healthcare Group
Information provided by (Responsible Party):
Conor Delaney, MD, PhD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00487409
First received: June 15, 2007
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

The purpose of this research is to compare two different standard of care surgical methods for the following large bowel (colon) procedures: laparoscopic right colectomy, total colectomy, and left colectomy. The study will compare electrocautery, used with surgical clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be looking at which procedure is faster and more cost efficient and the investigators will calculate hospital expenses for the two groups to make comparisons.


Condition Intervention
Colonic Diseases
Rectal Diseases
Procedure: Bipolar electrosurgical generator and instruments
Procedure: Disposable stapling instruments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Outcomes for the LigaSure and Disposable Stapling Instruments for Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • this study will evaluate the surgical approach using the Ligasure device at six weeks post operative. [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: Yes ]
    The objective of this study is to determine the best technical approach to laparoscopic right total and left colectomy by comparing the utilization of the Ligasure device to electrocautery with the application of surgical clips and or surgical staples. Safety, cost, operative time, time to pedicle ligation and hemostasis will be objectively measured in each treatment group.


Secondary Outcome Measures:
  • Will evaluate the surgical approach using electrocautery with surgical clips and staples [ Time Frame: 6 weeks post op ] [ Designated as safety issue: Yes ]
    The objective of this study is to determine the best technical approach to laparoscopic right total and left colectomy by comparing the utilization of the Ligasure device to electrocautery with the application of surgical clips and or surgical staples. Safety, cost, operative time, time to pedicle ligation and hemostasis will be objectively measured in each treatment group.


Enrollment: 100
Study Start Date: December 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Standard of Care
Procedure: Disposable stapling instruments
laparoscopic colectomy using clips, cautery and stapler
Other Name: Staples or Clips
Group B
Standard of Care
Procedure: Bipolar electrosurgical generator and instruments
laparoscopic colectomy using the Ligasure device
Other Name: Ligasure Device

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have benign or malignant colonic or rectal disease that mandate resection and are approached laparoscopically. Potential indications or conditions include ulcerative colitis, Crohn's disease, colorectal polyps, colorectal malignancy, endometriosis, diverticulitis, and colonic inertia
  • Subjects who are 18 years of age and older
  • Subjects of either sex
  • Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent

Exclusion Criteria:

  • Subjects who undergo conversion to the open approach before mobilization of the colon or pedicle ligation will be excluded from the analysis
  • Subjects who are pregnant
  • Subjects who have undergone a previous colectomy
  • Subjects with a medical condition that may interfere with the evaluation of safety or effectiveness of the study device
  • Subjects who have another condition that in the opinion of the investigator precludes further participation in the study
  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: NCT00487409

Locations
United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Tyco Healthcare Group
Investigators
Principal Investigator: Conor P. Delaney, MD, PhD University Hospitals of Cleveland/ Institute for Surgical Innovation
  More Information

No publications provided by University Hospitals of Cleveland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Conor Delaney, MD, PhD, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00487409     History of Changes
Other Study ID Numbers: 10-06-33
Study First Received: June 15, 2007
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Ulcerative colitis
Crohn's disease
Colorectal polyps
Colorectal malignancy
Endometriosis
Diverticulitis
Colonic inertia

Additional relevant MeSH terms:
Colonic Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014