Study Stopped
Industry Funding Withdrawn
Single Port Laparoscopic Colectomy
SILS
Single Incision Laparoscopic Right Hemi-colectomy Pilot Study
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 17, 2014
March 1, 2014
5 months
March 1, 2011
March 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 day
Secondary Outcomes (19)
Use of additional ports and reason
1 day
Conversion to an open procedure and reason
1 day
Duration of surgery
1 Day
Operative complications
1 Day
Total Length of surgical incision (cm)
30 days
- +14 more secondary outcomes
Study Arms (1)
SILS right hemicolectomy
EXPERIMENTALSingle arm with intervention only.
Interventions
above procedure using Roticulating instruments (from Covidien)
Eligibility Criteria
You may qualify if:
- Adult patients age 19 years or older diagnosed with resectable right colon cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Tyco Healthcare Groupcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 22, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
March 17, 2014
Record last verified: 2014-03