Stereotactic navigation for TAMIS-TME.

Stereotactic navigation allows for real-time, image-guided surgery, thus providing an augmented working environment for the operator. This technique can be applied to complex minimally invasive surgery for fixed anatomic targets. Transanal minimally invasive surgery represents a new approach to rectal cancer surgery that is technically demanding and introduces the potential for procedure-specific morbidity. Feasibility of stereotactic navigation for TAMIS-TME has been demonstrated, and this could theoretically translate into improved resection quality by improving the surgeon's spatial awareness. The future of minimally invasive surgery as it relates to augmented reality and image-guided surgery is discussed.

Transanal minimally invasive surgery (TAMIS) for local excision of benign neoplasms and early-stage rectal cancer: efficacy and outcomes in the first 50 patients.

BACKGROUND: Since its inception in 2009, transanal minimally invasive surgery has been used increasingly in the United States and internationally as an alternative to local excision and transanal endoscopic microsurgery for local excision of neoplasms in the distal and mid rectum. Despite its increasing acceptance, the clinical benefits of transanal minimally invasive surgery have not yet been validated. OBJECTIVE: The aim of this study is to assess the adequacy of transanal minimally invasive surgery for the local excision of benign and malignant lesions of the rectum. DESIGN: This is a retrospective analysis of consecutive patients who underwent transanal minimally invasive surgery for local excision of neoplasms at a single institution. SETTINGS: The study was conducted by a single group of colorectal surgeons at a tertiary referral center. PATIENTS: Eligible patients with early-stage rectal cancer and benign neoplasms were offered transanal minimally invasive surgery as a means for local excision. Data from these patients were collected prospectively in a registry. MAIN OUTCOME MEASURES: The primary outcome measures included the feasibility of transanal minimally invasive surgery for local excision, resection quality, and short-term clinical results. RESULTS: : Fifty patients underwent transanal minimally invasive surgery between July 2009 and December 2011. Twenty-five benign neoplasms, 23 malignant lesions, and 2 neuroendocrine tumors were excised. All lesions were excised using transanal minimally invasive surgery without conversion to an alternate transanal platform. The average length of stay was 0.6 days (range, 0-6), and 68% of patients were discharged on the day of surgery. The average distance from the anal verge was 8.1 cm (range, 3-14 cm). All lesions were excised completely with only 2 fragmented specimens (4%). All specimens were removed with grossly negative margins, although 3 (6%) were found to have microscopically positive margins on final pathology. There were 2 recurrences (4%) at 6- and 18-month follow-up. Early complications occurred in 3 patients (6%). No long-term complications were observed at a median follow-up of 20 months. LIMITATIONS: The study was limited by its retrospective nature and midterm follow-up. CONCLUSIONS: Transanal minimally invasive surgery is an advanced transanal platform that provides a safe and effective method for resecting benign neoplasms, as well as carefully selected, early-stage malignancies of the mid and distal rectum.

Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer.

OBJECTIVE: To test the hypothesis that surgeon volume would not predict short- and long-term outcomes when evaluated in the setting of technical credentialing. SUMMARY BACKGROUND DATA: Surgical volume is a known predictor of outcomes; the importance of technical credentialing has not been evaluated. METHODS: Fifty-three credentialed surgeons operated on 871 patients in the Clinical Outcomes of Surgical Therapy Study (NCT00002575), investigating laparoscopic versus open surgery for colon cancer. Credentialing required that each surgeon document performance of at least 20 laparoscopic colon cases and demonstrate oncologic techniques on a video-recorded case. Surgeons were separated based on volume entered into the trial (low, < or =5 cases (n = 39); medium, 6-10 cases (n = 9); or high, >10 cases (n = 5)) and compared by outcomes. RESULTS: Patients treated by high volume compared with medium or low volume surgeons were older (70, 66, and 68 years; P < 0.001), more often had right-sided tumors (63%, 46%, and 53%; P < 0.001) and had more previous operations (48%, 38% and 45%; P < 0.004), respectively. Mean operative times were shorter (123, 147 and 145 minutes; P < 0.001), distal margins longer (13.4, 12.4 and 11.6 cm; P = 0.005), and lymph node harvest greater (14.8, 12.8, 12.6; P = 0.05) for high versus medium versus low volume surgeons. However, rates of conversion, complications, 5-year survival, and disease-free survival showed no significant differences. CONCLUSION: When tested in a randomized controlled trial with case-specific surgical technical credentialing and auditing, surgeon volume did not predict differences in rates of conversion, complications, or long-term cancer outcomes. Case-specific technical credentialing should be further studied specific to the role it could play in creating consistent, high quality outcomes.

Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane: a prospective, randomized, evaluator-blinded multicenter study.

INTRODUCTION: Postoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients. METHODS: Twelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no anti-adhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision. RESULTS: Data were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P < 0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/carboxymethylcellulose than with control (P < 0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose. CONCLUSIONS: Glycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.

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.

A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures.

PURPOSE: The aim of this study was to determine the optimal dose and dosing interval of nitroglycerin ointment to heal chronic anal fissures. METHOD: A randomized, double-blind study of intra-anally applied nitroglycerin ointment (Anogesic) was conducted in 17 centers in 304 patients with chronic anal fissures. The patients were randomly assigned to one of eight treatment regimens (0.0, 0.1, 0.2, 0.4 percent nitroglycerin ointment applied twice or three times per day), for up to eight weeks. A dose-measuring device standardized the delivery of 374 mg ointment. Healing of fissures (complete reepithelialization) was assessed by physical examination using an observer unaware of treatment allocation. The subjects assessed pain intensity daily by completing a diary containing a visual analog scale for average pain intensity for the day, the worst pain intensity for the day, and pain intensity at the last defecation. RESULTS: There were no significant differences in fissure healing among any of the treatment groups; all groups, including placebo had a healing rate of approximately 50 percent. This rate of placebo response was inexplicably higher than previously reported in the literature. Treatment with 0.4 percent (1.5 mg) nitroglycerin ointment was associated with a significant (P < 0.0002) decrease in average pain intensity compared with vehicle as assessed by patients with a visual analog scale. The decreases were observed by Day 4 of treatment. At 8 weeks the magnitude of the difference between 0.4 percent nitroglycerin and control was a 21 percent reduction in average pain. Treatment was well tolerated, with only 3.29 percent of patients discontinuing treatment because of headache. Headaches were the primary adverse event and were dose related. CONCLUSION: Nitroglycerin ointment did not alter healing but significantly and rapidly reduced the pain associated with chronic anal fissures.