Single Port Laparoscopic Colectomy

Colon Cancer Clinical Trial

— SILS  

Official title:

Single Incision Laparoscopic Right Hemi-colectomy Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01320267
• Other study ID #: H10-00969
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 1, 2011
• Last updated: March 14, 2014
• Start date: December 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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:

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Procedure:
• Single port laparoscopic right hemicolectomy
above procedure using Roticulating instruments (from Covidien)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Tyco Healthcare Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	1 day	No
Secondary	Conversion to an open procedure and reason		1 day	Yes
Secondary	Duration of surgery		1 Day	No
Secondary	Operative complications	this includes, bleeding complications and inadvertant bowel or other abdominal visceral injury.	1 Day	Yes
Secondary	Total Length of surgical incision (cm)		30 days	No
Secondary	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 days	No
Secondary	30 Day Mortality		30 Days	Yes
Secondary	Length of postoperative hospital stay		30days	No
Secondary	Pathological Cancer stage (TNM)		15 Days	No
Secondary	Pathology: Resection margin clearance		15 Days	No
Secondary	Number of lymph nodes assessed		15 Days	Yes
Secondary	Total Number of Surgical Incisions		1 Day	No
Secondary	Wound Infection	yes/no, Deep Surgical site infection vs Superficial Surgical site infection.	30 Days	Yes
Secondary	Postoperative complications: Requirement of Re-operation	Yes/NO	30 Days	Yes
Secondary	Postoperative complications: Reason for reoperation	(if needed re-operation)	30 Days	Yes
Secondary	Postop Complications: Wound Dehiscence		30 Day	Yes
Secondary	Postoperative Complications: Others	including deep vein thrombosis/pulmonary embolism (DVT/PE), myocardial infarction, stroke and pneumonia	30 Day	Yes
Secondary	30 Day Re-admission		30 Days	Yes
Secondary	Postoperative Measure of Pain	Visual Analogue Scale to quantify pain on POD#1, #2 AND #3	3 DAYS	Yes