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Withdrawn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
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring Resectable right colon cancer
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
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
NCT ID
NCT01320267
First Posted
March 1, 2011
Last Updated
March 14, 2014
Sponsor
University of British Columbia
Collaborators
Tyco Healthcare Group
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
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Single Port Laparoscopic Colectomy
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