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Single Port Laparoscopic Colectomy (SILS)

Primary Purpose

Colon Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Single port laparoscopic right hemicolectomy
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Resectable right colon cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SILS right hemicolectomy

    Arm Description

    Single arm with intervention only.

    Outcomes

    Primary Outcome Measures

    Successful completion of the right hemicolectomy
    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
    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
    Duration of surgery
    Operative complications
    this includes, bleeding complications and inadvertant bowel or other abdominal visceral injury.
    Total Length of surgical incision (cm)
    Postoperative analgesia requirements (total opioid used)
    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
    Length of postoperative hospital stay
    Pathological Cancer stage (TNM)
    Pathology: Resection margin clearance
    Number of lymph nodes assessed
    Total Number of Surgical Incisions
    Wound Infection
    yes/no, Deep Surgical site infection vs Superficial Surgical site infection.
    Postoperative complications: Requirement of Re-operation
    Yes/NO
    Postoperative complications: Reason for reoperation
    (if needed re-operation)
    Postop Complications: Wound Dehiscence
    Postoperative Complications: Others
    including deep vein thrombosis/pulmonary embolism (DVT/PE), myocardial infarction, stroke and pneumonia
    30 Day Re-admission
    Postoperative Measure of Pain
    Visual Analogue Scale to quantify pain on POD#1, #2 AND #3

    Full Information

    First Posted
    March 1, 2011
    Last Updated
    March 14, 2014
    Sponsor
    University of British Columbia
    Collaborators
    Tyco Healthcare Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01320267
    Brief Title
    Single Port Laparoscopic Colectomy
    Acronym
    SILS
    Official Title
    Single Incision Laparoscopic Right Hemi-colectomy Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Industry Funding Withdrawn
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of British Columbia
    Collaborators
    Tyco Healthcare Group

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Purpose: The purpose of the study is to demonstrate that single port right hemi-colectomy can be performed with consistency. The second purpose is to assess single port surgery in terms of length of stay in the hospital, analgesics requirement, and length of scar at 30 days. The single port surgery is a latest advancement towards achieving minimal scarring after major abdominal surgery. Justification: Laparoscopic Colon resection is well-documented and standard practice in many centers throughout the world. A Cochrane Review of 25 Randomized Control Trials (RCT) published in 2005 looked at the short term (30 Days) benefits of laparoscopic colorectal resection showed better outcome in intra-operative blood loss, intensity of postoperative pain, postoperative hospital stay, duration of postoperative ileus, and pulmonary functions (1). Total morbidity and local (surgical) morbidity was decreased in the laparoscopic groups. Until the 30th postoperative day, quality of life was better in laparoscopic patients. They concluded if the long-term oncological results of laparoscopic and conventional resection of colonic carcinoma show equivalent results, the laparoscopic approach should be preferred in patients suitable for this approach to colectomy. A Cochrane Review published in 2008 looked at 33 RCT's comparing laparoscopic/Laparoscopic-assisted and open colectomy for colo-rectal carcinoma found similar long-term oncologic outcomes in both groups (2). Single Incision Laparoscopic Surgery (SILS) instead of traditional 4 ports theoretically may reduce the wound complications. For cholecystectomy, a blinded randomized control study showed significant reduction in pain control at sub-costal port-sites in 2-port versus 4-port laparoscopic cholecystectomy and also showed similar pain at umbilical port (3). There have been few reports of performing colectomy through a single port similar to the SILS cholecystectomy as mentioned above. Remzi et al published a report of performing sigmoid-colectomy for polyp using single umbilical tri-port system (4). Merchant et al used a single port (this time a Gel-port) to perform SILS right hemicolectomy (5). Bucher reported a case of single incision laparoscopic sigmoidectomy for stenosis due to endometriosis (6). They questioned if SILS colectomy offers benefits except in cosmesis, when compared to standard laparoscopic surgery. The above-mentioned publications of SILS colectomy used conventional and not so conventional instruments (curved and/or articulating forceps). The availability of these instruments due to technical advancement has opened the door for these procedures to be performed more routinely. In a recent study this technique was applied effectively and performed in comparable operative times to traditional 3-port cholecystectomy with a learning curve of approximately 5 cases (7). Recently Dixon et al.(8) demonstrated by performing variety of colo-rectal procedures using a single port laparoscopic technique. They performed, right hemi-colectomy, extended right hemi-colectomy, total colectomy with ileo-anal anastomosis, procto-colectomy, restorative procto-colectomy with ileo-anal pouch formation and anterior resection. Two of these procedures were for cancers. All operations were performed using a single incision tri-port system with harmonics scalpel, linear/circular stapler and standard laparoscopic instruments. Methods: The investigators will assess short-term outcome variables for the single incision laparoscopic resection procedure in a pilot study of 20 patients diagnosed with resectable right colon cancer. The investigators will compare these short term outcome variables to an aggregate group of patients that previously had undergone standard 4-port laparoscopic resection of right colon cancer in a 12-month period (2009). The outcome variables are: Successful completion of the right hemicolectomy Use of additional ports and reason Conversion to an open procedure and reason Duration of the surgery Operative complications Number and total length of surgical incisions Postoperative analgesia requirements Postoperative complications Length of postoperative hospital stay Cancer stage (TNM) Resection margin clearance Number of lymph nodes assessed Data collection: Data will be collected prospectively for patients undergoing the single port laparoscopic resection. Data will be abstracted retrospectively from electronic hospital and office charts for patients that previously had standard laparoscopic resection of right colon cancer. Statistical analysis: Demographic, operative and postoperative data will be summarized and reported as counts and percents for categorical variables and Mean ± Standard Deviation (plus Median & Min. Max.) for continuous variables. Outcomes of the two groups will be compared by independent samples t-tests and non-parametric median tests for continuous variables and Chi-square or Fisher's exact tests for categorical variables. Sample size: The pilot study sample size of 20 was chosen on the basis of a reasonable number of patients to be recruited in one year. The comparison group size for patients previously having standard laparoscopic resection was chosen only for convenience but is estimated at approximately 20 patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer
    Keywords
    Resectable right colon cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SILS right hemicolectomy
    Arm Type
    Experimental
    Arm Description
    Single arm with intervention only.
    Intervention Type
    Procedure
    Intervention Name(s)
    Single port laparoscopic right hemicolectomy
    Intervention Description
    above procedure using Roticulating instruments (from Covidien)
    Primary Outcome Measure Information:
    Title
    Successful completion of the right hemicolectomy
    Description
    The first and main outcome is to assess if right hemicolectomy can be safely performed using the Single Port.
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Use of additional ports and reason
    Description
    This is to see that even using roticulating laparoscopic instruments, how often and how many additional ports were placed.
    Time Frame
    1 day
    Title
    Conversion to an open procedure and reason
    Time Frame
    1 day
    Title
    Duration of surgery
    Time Frame
    1 Day
    Title
    Operative complications
    Description
    this includes, bleeding complications and inadvertant bowel or other abdominal visceral injury.
    Time Frame
    1 Day
    Title
    Total Length of surgical incision (cm)
    Time Frame
    30 days
    Title
    Postoperative analgesia requirements (total opioid used)
    Description
    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.
    Time Frame
    30 days
    Title
    30 Day Mortality
    Time Frame
    30 Days
    Title
    Length of postoperative hospital stay
    Time Frame
    30days
    Title
    Pathological Cancer stage (TNM)
    Time Frame
    15 Days
    Title
    Pathology: Resection margin clearance
    Time Frame
    15 Days
    Title
    Number of lymph nodes assessed
    Time Frame
    15 Days
    Title
    Total Number of Surgical Incisions
    Time Frame
    1 Day
    Title
    Wound Infection
    Description
    yes/no, Deep Surgical site infection vs Superficial Surgical site infection.
    Time Frame
    30 Days
    Title
    Postoperative complications: Requirement of Re-operation
    Description
    Yes/NO
    Time Frame
    30 Days
    Title
    Postoperative complications: Reason for reoperation
    Description
    (if needed re-operation)
    Time Frame
    30 Days
    Title
    Postop Complications: Wound Dehiscence
    Time Frame
    30 Day
    Title
    Postoperative Complications: Others
    Description
    including deep vein thrombosis/pulmonary embolism (DVT/PE), myocardial infarction, stroke and pneumonia
    Time Frame
    30 Day
    Title
    30 Day Re-admission
    Time Frame
    30 Days
    Title
    Postoperative Measure of Pain
    Description
    Visual Analogue Scale to quantify pain on POD#1, #2 AND #3
    Time Frame
    3 DAYS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Single Port Laparoscopic Colectomy

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