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Single Incision Laparoscopic Right Hemi-colectomy Pilot Study

Phase 1/Phase 2
18 Years
Not Enrolling
Colon Cancer

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Trial Information

Single Incision Laparoscopic Right Hemi-colectomy Pilot Study


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.


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


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:

1. Successful completion of the right hemicolectomy

2. Use of additional ports and reason

3. Conversion to an open procedure and reason

4. Duration of the surgery

5. Operative complications

6. Number and total length of surgical incisions

7. Postoperative analgesia requirements

8. Postoperative complications

9. Length of postoperative hospital stay

10. Cancer stage (TNM)

11. Resection margin clearance

12. 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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Successful completion of the right hemicolectomy

Outcome Description:

The first and main outcome is to assess if right hemicolectomy can be safely performed using the Single Port.

Outcome Time Frame:

1 day

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

December 2011

Completion Date:

December 2012

Related Keywords:

  • Colon Cancer
  • Resectable right colon cancer
  • Colonic Neoplasms