Development and validation of a model to predict outcomes of colon cancer surveillance.

PURPOSE: Clinical trials suggest that intensive surveillance of colon cancer (CC) survivors to detect recurrence increases curative-intent treatment, although any survival benefit of surveillance as currently practiced appears modest. Realizing the potential of surveillance will require tools for identifying patients likely to benefit and for optimizing testing regimens. We describe and validate a model for predicting outcomes for any schedule of surveillance in CC survivors with specified age and cancer stage. METHODS: A Markov process parameterized based on individual-level clinical trial data generates natural history events for simulated patients. A utilization submodel simulates surveillance and diagnostic testing. We validate the model against outcomes from the follow-up after colorectal surgery (FACS) trial. RESULTS: Prevalidation sensitivity analysis showed no parameter influencing curative-intent treatment by > 5.0% or overall five-year survival (OS5) by > 1.5%. In validation, the proportion of recurring subjects predicted to receive curative-intent treatment fell within FACS 95% CI for carcinoembryonic antigen (CEA)-intensive, computed tomography (CT)-intensive, and combined CEA+CT regimens, but not for a minimum surveillance regimen, where the model overestimated recurrence and curative treatment. The observed OS5 fell within 95% prediction intervals for all regimens. CONCLUSION: The model performed well in predicting curative surgery for three of four FACS arms. It performed well in predicting OS5 for all arms.

Prospective Case Series of a Novel Minimally Invasive Bipolar Coagulation System in the Treatment of Grade I and II Internal Hemorrhoids.

Background Existing nonsurgical procedures for the treatment of grade I and II internal hemorrhoids are often painful, technically demanding, and often necessitate multiple applications. This study prospectively assessed the safety and efficacy of the HET Bipolar System, a novel minimally invasive device, in the treatment of symptomatic grade I and II internal hemorrhoids. Methods Patients with symptomatic grade I or II internal hemorrhoids despite medical management underwent hemorrhoidal ligation with the HET Bipolar System. Endpoints included resolution or improvement of hemorrhoidal bleeding and/or prolapse from baseline, recurrent or refractory symptoms, and pain. Results Twenty patients were treated with the HET Bipolar System. Two were lost to follow-up. Refractory or recurrent bleeding was present in 8 of 18 (44.4%), 4 of 11 (36.4%), and 4 of 8 (50.0%) patients, and prolapse was reported by 1 of 18 (5.6%), 4 of 11 (36.4%), and 1/7 (14.3%) of patients at 1, 3, and 6 months, respectively. Bleeding improved from baseline in 88.2%, 81.8%, and 87.5% of patients, and resolution of baseline prolapse was seen in 11 of 11 (100%), 4 of 7 (57.1%), and 5 of 5 (100%) patients at the same intervals. Thirteen of 18 (72.2%) patients did not require additional treatment for their symptoms. Conclusions The HET Bipolar System is safe and easy to use with short-term effectiveness comparable to that of currently used techniques for the treatment of symptomatic grade I and II internal hemorrhoids. It may be an effective alternative to rubber band ligation in patients with larger internal hemorrhoids and those with hemorrhoids close to the dentate line in which banding may produce debilitating pain.

The effect of transversus abdominis plane blocks on postoperative pain in laparoscopic colorectal surgery: a prospective, randomized, double-blind trial.

BACKGROUND: Superior early pain control has been suggested with transversus abdominis plane blocks, but evidence-based recommendations for transversus abdominis plane blocks and their effects on patient outcomes are lacking. OBJECTIVE: The aim of this study was to determine whether transversus abdominis plane blocks improve early postoperative outcomes in patients undergoing laparoscopic colorectal resection already on an optimized enhanced recovery pathway. DESIGN: This study is based on a prospective, randomized, double-blind controlled trial. SETTINGS: The trial was conducted at a tertiary referral center. PATIENTS: Patients undergoing elective laparoscopic colorectal resection were selected. INTERVENTIONS(S): Patients were randomly assigned to receive either a transversus abdominis plane block or a placebo placed intraoperatively under laparoscopic guidance. All followed a standardized enhanced recovery pathway. Patient demographics, perioperative procedures, and postoperative outcomes were collected. MAIN OUTCOME MEASURES: Postoperative pain and nausea/vomiting scores in the postanesthesia care unit and department, opioid use, length of stay, and 30-day readmission rates were measured. RESULTS: The trial randomly assigned 41 patients to the transversus abdominis plane block group and 38 patients to the control group. Demographic, clinical, and procedural data were not significantly different. In the postanesthesia care unit, the transversus abdominis plane block group had significantly lower pain scores (p < 0.01) and used fewer opioids (p < 0.01) than the control group; postoperative nausea/vomiting scores were comparable (p = 0.99). The transversus abdominis plane group had significantly lower pain scores on postoperative day 1 (p = 0.04) and throughout the study period (p < 0.01). There was no significant difference between groups in postoperative opioid use (p = 0.65) or nausea/vomiting (p = 0.79). The length of stay (median, 2 days experimental, 3 days control; p = 0.50) and readmission rate (7% experimental, 5% control, p = 0.99) was similar across cohorts. LIMITATIONS: This study was conducted a single center. CONCLUSIONS: Transversus abdominis plane blocks improved immediate short-term opioid use and pain outcomes. Pain improvement was durable throughout the hospital stay. However, the blocks did not translate into less overall narcotic use, shorter length of stay, or lower readmission rates.

Pilot study evaluating the efficacy of AlloMEM™ for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy.

OBJECTIVE: This study was designed to evaluate the feasibility of AlloMEM™, a novel lyophililzed human peritoneal membrane, at peritoneal reconstitution, and decreasing adhesion formation after temporary loop ileostomy. METHODS: In a pilot study, ten patients had AlloMEM™ used during elective formation of a temporary diverting loop ileostomy for benign or malignant colorectal disease. A blinded investigator and the operating surgeon analyzed the change in adhesion formation and peritoneal remodelling using ileostomy mobilization time and a 5-point adhesion scale grading intra-abdominally and at the subcutaneous and fascial levels. RESULTS: The mean body mass index was 31 [standard deviation (SD) 5.6], and 40 % of patients had previous abdominal surgery. Ileostomies were reversed after a mean 14 weeks (SD 6.0). The mean ileostomy mobilization time was 27.2 min (SD 12.0). From baseline to ileostomy reversal, there were significant increases in adhesions at the subcutaneous (p = 0.0002) and fascial levels (p = 0.0024). The increased subcutaneous adhesions were associated with improved peritoneal remodeling. There was no significant increase in adhesions from baseline to ileostomy reversal at the intra-abdominal points (p = 0.9393) or around the ileostomy site (p = 0.6128). The median hospital length of stay was 2.6 days (range, 2-3). A single adverse event related to product packaging led to redesign of the packaging process. CONCLUSIONS: Use of AlloMEM™ in ileostomy closures suggested improvement in adhesions around the fascia and promotion of peritoneal remodeling. AlloMEM™ was safe, feasible, and easy to use in this pilot study. Comparative research is needed to assess the outcomes with this novel product.

Demonstrating the benefits of transversus abdominis plane blocks on patient outcomes in laparoscopic colorectal surgery: review of 200 consecutive cases.

BACKGROUND: Quality improvement in colorectal surgery (CRS) requires implementation of tools to improve patient and financial outcomes, and assessment of results. Our objective was to evaluate the durability of transversus abdominis plane (TAP) blocks and a standardized enhanced recovery protocol (ERP) on a large series of laparoscopic colorectal resections. STUDY DESIGN: Two hundred consecutive laparoscopic CRS patients received TAP blocks under laparoscopic guidance at the end of their operation. All were managed with a standardized ERP. Demographic, perioperative, and postoperative outcomes variables were analyzed. The main outcomes measures were length of stay (LOS), readmission, reoperation, morbidity, and mortality rates. RESULTS: Of 200 cases, 194 were elective and 6 emergent. The main diagnosis was colorectal cancer (45%). The mean patient age was 61.2 years, mean body mass index was 29.2 kg/m(2), and the majority (63%) were American Society of Anesthesiologists (ASA) class III. The main procedure performed was a segmental colectomy (64%). Mean operative time was 181 minutes. Nine cases (4.5%) were converted to open. The median LOS was 2 days (range 1 to 8 days). Twenty-one percent were discharged by postoperative day (POD) 1, 41% by POD 2, and 77% by POD 3. By POD 7, 99% were discharged. Twelve percent (n = 24) had complications, and 6.5% (n = 13) were readmitted. There were 3 unplanned reoperations and no mortalities. Comparing the first and second groups of 100 consecutive patients further tested the consistency of the TAP block benefit. With comparable demographics, there were no significant differences in readmission, complication, or reoperation rates over the entire series. CONCLUSIONS: Adding TAP blocks to an ERP facilitated shorter LOS with low readmission and reoperation rates when compared to previously published series. The effect appears durable and consistent in a large case series. Transversus abdominis plane blocks may be an efficient, cost-effective method for improving laparoscopic CRS results.