Single Port Laparoscopic Colectomy (SILS)

This study has been withdrawn prior to enrollment.
(Industry Funding Withdrawn)
Sponsor:
Collaborator:
Tyco Healthcare Group
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01320267
First received: March 1, 2011
Last updated: March 14, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopic Right Hemi-colectomy Pilot Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Successful completion of the right hemicolectomy [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Duration of surgery [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Operative complications [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
    this includes, bleeding complications and inadvertant bowel or other abdominal visceral injury.

  • Total Length of surgical incision (cm) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Postoperative analgesia requirements (total opioid used) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Length of postoperative hospital stay [ Time Frame: 30days ] [ Designated as safety issue: No ]
  • Pathological Cancer stage (TNM) [ Time Frame: 15 Days ] [ Designated as safety issue: No ]
  • Pathology: Resection margin clearance [ Time Frame: 15 Days ] [ Designated as safety issue: No ]
  • Number of lymph nodes assessed [ Time Frame: 15 Days ] [ Designated as safety issue: Yes ]
  • Total Number of Surgical Incisions [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Wound Infection [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    yes/no, Deep Surgical site infection vs Superficial Surgical site infection.

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

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

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

  • 30 Day Re-admission [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Postoperative Measure of Pain [ Time Frame: 3 DAYS ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01320267     History of Changes
Other Study ID Numbers: H10-00969
Study First Received: March 1, 2011
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 26, 2014