Clinical trial NCT01320267: Single Port Laparoscopic Colectomy
Official title: Single Incision Laparoscopic Right Hemi-colectomy Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Colon Cancer
Keywords: Resectable right colon cancer
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Tyco Healthcare Group
First posted: 2011-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Successful completion of the right hemicolectomy
timeFrame: 1 day
Secondary outcomes:
measure: Use of additional ports and reason
timeFrame: 1 day
measure: Conversion to an open procedure and reason
timeFrame: 1 day
measure: Duration of surgery
timeFrame: 1 Day
measure: Operative complications
timeFrame: 1 Day
measure: Total Length of surgical incision (cm)
timeFrame: 30 days
measure: Postoperative analgesia requirements (total opioid used)
timeFrame: 30 days
measure: 30 Day Mortality
timeFrame: 30 Days
measure: Length of postoperative hospital stay
timeFrame: 30days
measure: Pathological Cancer stage (TNM)
timeFrame: 15 Days
measure: Pathology: Resection margin clearance
timeFrame: 15 Days
measure: Number of lymph nodes assessed
timeFrame: 15 Days
measure: Total Number of Surgical Incisions
timeFrame: 1 Day
measure: Wound Infection
timeFrame: 30 Days
measure: Postoperative complications: Requirement of Re-operation
timeFrame: 30 Days
measure: Postoperative complications: Reason for reoperation
timeFrame: 30 Days
measure: Postop Complications: Wound Dehiscence
timeFrame: 30 Day
measure: Postoperative Complications: Others
timeFrame: 30 Day
measure: 30 Day Re-admission
timeFrame: 30 Days
measure: Postoperative Measure of Pain
timeFrame: 3 DAYS
Other outcomes:
Locations:
Study officials:
References: