Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery

NCT00487409 | Completed

• 1 other identifier: 10-06-33
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ulcerative colitis; Crohn's disease; Colorectal polyps; Colorectal malignancy; Endometriosis; Diverticulitis; Colonic inertia

Outcome Measures

Primary Outcomes (1)

• this study will evaluate the surgical approach using the Ligasure device at six weeks post operative.

  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.

  6 weeks post-op

Secondary Outcomes (1)

• Will evaluate the surgical approach using electrocautery with surgical clips and staples

  6 weeks post op

Study Arms (2)

Group A

OTHER

Standard of Care

Procedure: Disposable stapling instruments

Group B

OTHER

Standard of Care

Procedure: Bipolar electrosurgical generator and instruments

Interventions

Bipolar electrosurgical generator and instruments PROCEDURE

laparoscopic colectomy using the Ligasure device

Also known as: Ligasure Device

Group B

Disposable stapling instruments PROCEDURE

laparoscopic colectomy using clips, cautery and stapler

Also known as: Staples or Clips

Group A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Tyco Healthcare Group: collaborator

Study Sites (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Adamina M, Champagne BJ, Hoffman L, Ermlich MB, Delaney CP. Randomized clinical trial comparing the cost and effectiveness of bipolar vessel sealers versus clips and vascular staplers for laparoscopic colorectal resection. Br J Surg. 2011 Dec;98(12):1703-12. doi: 10.1002/bjs.7679. Epub 2011 Oct 13.

  PMID: 21997317 DERIVED

MeSH Terms

Conditions

Colonic Diseases; Rectal Diseases; Colitis, Ulcerative; Crohn Disease; Endometriosis; Diverticulitis; Constipation

Interventions

Sutures; Surgical Instruments

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Diverticular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Conor P. Delaney, MD, PhD

  University Hospitals of Cleveland/ Institute for Surgical Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: December 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

US (1)