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Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery

NCT00487409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Colonic Diseases
  • Rectal Diseases

Interventions

PROCEDURE

Bipolar electrosurgical generator and instruments

laparoscopic colectomy using the Ligasure device

PROCEDURE

Disposable stapling instruments

laparoscopic colectomy using clips, cautery and stapler

Sponsors & Collaborators

  • Tyco Healthcare Group

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Conor P. Delaney, MD, PhD · University Hospitals of Cleveland/ Institute for Surgical Innovation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487409 on ClinicalTrials.gov