Single Port Laparoscopic Colectomy (SILS)
This study is not yet open for participant recruitment.
Verified November 2011 by University of British Columbia
Sponsor:
University of British Columbia
Collaborator:
Tyco Healthcare Group
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01320267
First received: March 1, 2011
Last updated: November 22, 2011
Last verified: November 2011
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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
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320267
Contacts
| Contact: RANA SA KHAN, MBBS | R.S.A.KHAN@GMAIL.COM | |
| Contact: TERRY PHANG, MD, FRCSC,FACS | 604-806-8711 | tphang@providencehealth.bc.ca |
Locations
| Canada, British Columbia | |
| St. Paul's Hospital, Providence Health Care | Not yet recruiting |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Contact: TERRY PHANG, MD, MSc, FRCSC, FACS 604-806-8711 tphang@providencehealth.bc.ca | |
| Sub-Investigator: RANA SA KHAN, MBBS | |
| Principal Investigator: TERRY PHANG, MD, FACS | |
| Sub-Investigator: MANOJ RAVAL, MD, FRCSC | |
| Sub-Investigator: CARL BROWN, MD, FRCSC | |
Sponsors and Collaborators
University of British Columbia
Tyco Healthcare Group
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: | November 22, 2011 |
| 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 May 16, 2013