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Single Port Laparoscopic Colectomy (SILS)

This study has been withdrawn prior to enrollment.
(Industry Funding Withdrawn)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320267
First Posted: March 22, 2011
Last Update Posted: March 17, 2014
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.
Collaborator:
Tyco Healthcare Group
Information provided by (Responsible Party):
University of British Columbia
  Purpose

The investigators will document the success for completing laparoscopic resection of cancer in the right colon using a new single port access technique. The current procedure requires 4 incisions for 4 separate ports. With technological advancement of newly designed instruments it is now possible to do the same laparoscopic procedure through a single port. The investigators want to demonstrate here in British Columbia that it is a safe procedure with similar success and outcomes compared to the standard 4-port laparoscopic operation.

The investigators propose that this procedure may provide early discharge due to less pain and also be associated with less wound infection and hernia complications. The single incision will have improved cosmesis compared to the standard 4-port standard laparoscopic procedure.


Condition Intervention Phase
Colon Cancer Procedure: Single port laparoscopic right hemicolectomy Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopic Right Hemi-colectomy Pilot Study

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Successful completion of the right hemicolectomy [ Time Frame: 1 day ]
    The first and main outcome is to assess if right hemicolectomy can be safely performed using the Single Port.


Secondary Outcome Measures:
  • Use of additional ports and reason [ Time Frame: 1 day ]
    This is to see that even using roticulating laparoscopic instruments, how often and how many additional ports were placed.

  • Conversion to an open procedure and reason [ Time Frame: 1 day ]
  • Duration of surgery [ Time Frame: 1 Day ]
  • Operative complications [ Time Frame: 1 Day ]
    this includes, bleeding complications and inadvertant bowel or other abdominal visceral injury.

  • Total Length of surgical incision (cm) [ Time Frame: 30 days ]
  • Postoperative analgesia requirements (total opioid used) [ Time Frame: 30 days ]
    total mg of Morphine used. If morphine is not used and alternative opioid used, this will be coverted standard conversion to equivalent dose of Morphine.

  • 30 Day Mortality [ Time Frame: 30 Days ]
  • Length of postoperative hospital stay [ Time Frame: 30days ]
  • Pathological Cancer stage (TNM) [ Time Frame: 15 Days ]
  • Pathology: Resection margin clearance [ Time Frame: 15 Days ]
  • Number of lymph nodes assessed [ Time Frame: 15 Days ]
  • Total Number of Surgical Incisions [ Time Frame: 1 Day ]
  • Wound Infection [ Time Frame: 30 Days ]
    yes/no, Deep Surgical site infection vs Superficial Surgical site infection.

  • Postoperative complications: Requirement of Re-operation [ Time Frame: 30 Days ]
    Yes/NO

  • Postoperative complications: Reason for reoperation [ Time Frame: 30 Days ]
    (if needed re-operation)

  • Postop Complications: Wound Dehiscence [ Time Frame: 30 Day ]
  • Postoperative Complications: Others [ Time Frame: 30 Day ]
    including deep vein thrombosis/pulmonary embolism (DVT/PE), myocardial infarction, stroke and pneumonia

  • 30 Day Re-admission [ Time Frame: 30 Days ]
  • Postoperative Measure of Pain [ Time Frame: 3 DAYS ]
    Visual Analogue Scale to quantify pain on POD#1, #2 AND #3


Enrollment: 0
Study Start Date: December 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SILS right hemicolectomy
Single arm with intervention only.
Procedure: Single port laparoscopic right hemicolectomy
above procedure using Roticulating instruments (from Covidien)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients age 19 years or older diagnosed with resectable right colon cancer

Exclusion Criteria:

  • Advanced cancer on routine preoperative CT (local invasion, distant metastases)
  • maximum diameter of cancer > 5cm
  • previous abdominal surgery
  • emergency surgery
  • pregnancy
  • ages < 18 years old
  • ASA (American Society of Anesthesiologists) Class III or above
  • Any other contraindications to laparoscopic surgery
  • Non-English speaking/reading or unable to give consent
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01320267     History of Changes
Other Study ID Numbers: H10-00969
First Submitted: March 1, 2011
First Posted: March 22, 2011
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by University of British Columbia:
Resectable right colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases