Single Port Laparoscopic Colectomy (SILS)
|ClinicalTrials.gov Identifier: NCT01320267|
Recruitment Status : Withdrawn (Industry Funding Withdrawn)
First Posted : March 22, 2011
Last Update Posted : March 17, 2014
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 or disease||Intervention/treatment||Phase|
|Colon Cancer||Procedure: Single port laparoscopic right hemicolectomy||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Incision Laparoscopic Right Hemi-colectomy Pilot Study|
|Study Start Date :||December 2011|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
Experimental: SILS right hemicolectomy
Single arm with intervention only.
Procedure: Single port laparoscopic right hemicolectomy
above procedure using Roticulating instruments (from Covidien)
- 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.
- 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