Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study.

BACKGROUND: Circular staplers perform a critical function for creation of anastomoses in colorectal surgeries. Powered stapling systems allow for reduced force required by surgeons to fire the device and may provide advantages for creating a secure anastomosis. The objective of this study was to evaluate the clinical performance of a novel circular powered stapler in a post-market setting, during left-sided colectomy procedures. MATERIALS AND METHODS: Consecutive subjects underwent left-sided colorectal resections that included anastomosis performed with the ECHELON CIRCULAR™ Powered Stapler (ECP). The primary endpoint was the frequency in which a stapler performance issue was observed. Secondary endpoints included evaluation of ease of use of the device via a surgeon satisfaction questionnaire, and monitoring/recording of procedure-related adverse events (AEs). RESULTS: A total of 168 anastomoses were performed with the ECP. Surgical approaches included robotic-assisted (n = 74, 44.0%), laparoscopic (n = 71, 42.3%), open (n = 20, 11.9%), and hand-assisted minimally invasive (n = 3, 1.8%) procedures. There were 22 occurrences of device performance issues in 20 (11.9%) subjects during surgery. No positive intraoperative leak tests were observed, and only 1 issue was related to a procedure-related AE or surgical complication, which was an instance of incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the ECP as easier to use compared to previously used manual circular staplers in 85.7% of procedures. CONCLUSION: The circular powered stapler exhibited few clinically relevant performance issues, an overall favorable safety profile, and ease of use for creation of left-sided colon anastomoses.

Prospective comparison of laparoscopic vs. open resections for colorectal adenocarcinoma over a ten-year period.

PURPOSE: The aim of this study was to define the long-term oncologic outcomes of laparoscopic resections for colorectal cancer. METHODS: We analyzed our experience via a prospective, nonrandomized, longitudinal cohort study. The period of study extended from April 1991 to May 2001. Laparoscopic resection was offered selectively in the absence of a large mass, invasion into abdominal wall or adjacent organs, and multiple prior abdominal operations. Every laparoscopic resection performed with curative intent for adenocarcinoma was included. Twenty percent of patients whose procedures were converted to open resection were included in the laparoscopic-resection group because of intention to treat. Oncologic outcome measures of this group were compared with a computerized, case-matched, open-resection group, the case-matching variables being age, gender, site of primary tumor (colon vs. rectum), and TNM stage. The laparoscopic-resection group was followed up prospectively, and data were updated regularly. The follow-up techniques consisted of a combination of office visits, telephone calls, and the United States Social Security Death Index database. RESULTS: The laparoscopic-resection group consisted of 172 patients with a mean age of 67 (range, 27-85) years. The open-resection group consisted of 172 patients with a mean age of 69 (range, 30-90) years. Mean follow-up was 52 (range, 3-128) months. Complete (100 percent) follow-up data were available. The TNM stage distribution was 63 Stage I (37 percent), 51 Stage II (30 percent), 47 Stage III (27 percent), and 11 Stage IV (6 percent) tumors for the laparoscopic-resection group and 65 Stage I (38 percent), 48 Stage II (28 percent), 51 Stage III (29 percent), and 8 Stage IV (5 percent) tumors for patients in the open-resection group (P = 0.75, not significant). Thirty-day mortality was 1.2 percent (2 deaths) in the laparoscopic-resection group and 2.4 percent (4 deaths) in the open-resection group (P > 0.05, not significant). Early and late complication incidences were comparable. Local recurrence was observed in three patients (1.7 percent) in the laparoscopic resection group with the primary tumor in the colon and in three patients (1.7 percent) with the primary tumor in the rectum, for a total incidence of local recurrence in the laparoscopy group of 3.5 percent (6 patients). In the open-resection group, local recurrence was observed in two patients (1.2 percent) among those with primary tumor site in the colon and in three patients (1.7 percent) in the group with primary tumor in the rectum, for a total incidence of local recurrence in the open-resection group of 2.9 percent (5 patients). One of the local recurrences in the laparoscopy group occurred in the port/extraction site, for an incidence of 0.6 percent. Metastasis occurred in 18 patients (10.5 percent) in the open group and in 21 (12.2 percent) in the laparoscopy group. Stage-for-stage overall five-year survival rates were similar in the two groups. The Kaplan-Meier statistical analysis performed for colonic vs. rectal primary adenocarcinoma confirmed that TNM stage for stage-overall survival was similar in the laparoscopic and open-resection groups (log-rank P = 0.22). CONCLUSIONS: Notwithstanding the drawbacks of a nonrandomized study, no adverse long-term oncologic outcomes of laparoscopic resections for colorectal cancer were observed in a single center's experience during a ten-year period.