Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

Mesh sutured repairs of contaminated incisional hernias.

BACKGROUND: We sought to evaluate the results of a new mesh sutured repair technique for closure of contaminated incisional hernias. METHODS: 48 patients with contaminated hernias 5 cm wide or greater by CT scan were closed with mesh sutures. Surgical site occurrence, infections, and hernia recurrence were compared to similar patient series reported in the literature. RESULTS: Of the 48 patients, 20 had clean-contaminated wounds, 16 had contaminated wounds, and 12 were infected. 69% of the patients underwent an anterior perforator sparing components release for hernias that averaged 10.5 cm transversely (range 5 cm-25 cm). SSO occurred in 27% of patients while SSI was 19%. There were no fistulas or delayed suture sinuses. With a mean follow-up of almost 12 months, 3 midline hernias recurred (6%). In these same patients, three parastomal hernias repaired with mesh sutures failed out of 4 attempted for a total failure rate of 13%. CONCLUSION: Mesh sutured closure represents a simplified and effective surgical strategy for contaminated midline incisional hernia repair.

Fecal Incontinence: Epidemiology, Impact, and Treatment.

Fecal incontinence (FI) is a chronic and debilitating condition that carries a significant health, economic, and social burden. FI has a considerable psychosocial and financial impact on patients and their families. A variety of treatment modalities are available for FI including behavioral and dietary modifications, pharmacotherapy, pelvic floor physical therapy, bulking agents, anal sphincteroplasty, sacral nerve stimulation, artificial sphincters, magnetic sphincters, posterior anal sling, and colostomy.

Comparison of the Effect of Instrument Type on Transanal Endoscopic Surgery Learning Curves.

BACKGROUND: Transanal endoscopic surgery (TES) can be technically difficult due to the constraints of operating through a narrow proctoscope channel. In this study, we compared the performance of surgical novices using instruments with and without articulating shafts to perform a simulated TES task. METHODS: Medical students each performed 10 repetitions of the Fundamentals of Laparoscopic Surgery circle-cut task. Participants were randomized into 3 groups: 2 performed the task through a TES proctoscope using scissors with either a rigid (TES-R) or articulating (TES-A) shaft. The third group performed the task laparoscopically (LAP). RESULTS: A total of 31 medical students participated. The LAP group had a faster mean task time than both the TES-R and TES-A groups (LAP 201±120 s vs. TES-R 362±212 s and TES-A 405±212 s, both P <0.001). The TES-R group made more errors (ie, deviation from a perfect circle) than both the other groups. The TES-R group adjusted the proctoscope position during more repetitions than the TES-A group. CONCLUSIONS: Students had faster task times when operating laparoscopically than through a TES protoscope. Task times were similar between the TES groups using scissors with articulating and rigid shafts; however, use of the articulating instruments resulted in fewer errors and less need to adjust proctoscope position.

Should Oral Contrast Be Omitted in Patients with Suspected Appendicitis?

BACKGROUND: Acute appendicitis is one of the most common surgical emergencies. Our study evaluated patients given the diagnosis of appendicitis and reviewed their workup and clinical outcomes. We specifically focused on the use of oral contrast followed by appendectomy. METHODS: We retrospectively reviewed all adult patients given an ICD-9 code for appendicitis at Northwestern Memorial Hospital between January 2000 and September 2010. Complication rates, time to the operating room, and length of hospital stay were compared between patients who received a CT scan and those who did not during the hospitalization for appendicitis. RESULTS: Average time from Emergency Department to the operating room was found to be statistically longer for patients who underwent a CT scan (10 h: 3, 1548) versus those who did not (6 h: 2, 262) (p < 0.0001). There were 19 patients who had the complication of pneumonia and 4 patients who were diagnosed with acute respiratory distress syndrome postoperatively. Patients who underwent a CT scan and received oral contrast had a statistically higher number of both complications (p < 0.0001). CONCLUSIONS: The use of oral contrast is not necessary for an accurate diagnosis of appendicitis and may be associated with higher complication rates, longer hospital stays, and poor outcomes.

The anthropometric definition of the rectum is highly variable.

PURPOSE: The precise definition of the rectum is essential for localizing colorectal pathology, yet current definitions are nebulous. The objective of this study is to determine the anthropometric definition of common pelvic landmarks in relation to patient characteristics. METHODS: Seventy-one patients underwent open proctectomy with intra-operative measurements from the anal verge to various pelvic landmarks, and patient characteristics were evaluated. Analyses were performed using Spearman correlation and Wilcoxon rank sum. RESULTS: The mean landmark distance was dentate line = 1.7 cm (range 0.8-4.0 cm), puborectalis muscle = 4.2 cm (range 2.0-8.0 cm), anterior peritoneal reflection = 13.2 cm (range 8.5-21.0 cm), sacral promontory = 17.9 cm (range 13.0-26.0 cm), and confluence of the taenia = 25.5 cm (range 16.0-44.0 cm). Men had longer mean distances to the dentate line (p = 0.0003), puborectalis muscle (p = 0.03), and anterior peritoneal reflection (p = 0.02). Patient weight significantly correlated with distance to all landmarks except for the confluence of the taenia, which did not correlate with any patient factor. CONCLUSIONS: The location of common pelvic landmarks is highly variable. The use of predefined absolute measurements from the anal verge to localize rectal pathology is inaccurate and fails to account for patient variability.

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial.

IMPORTANCE: Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE: To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS: Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES: The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation. RESULTS: Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, -5.3%; 1-sided 95% CI, -10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, -0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, -0.7%; 95% CI, -4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, -4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE: Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00726622.

Sacral Nerve Stimulation in the Treatment of Bowel Disorders.

Defecation problems occur in patients of all ages, but are more prevalent in the elderly, postpartum women, and patients with chronic and debilitating medical conditions. Most of the time, these problems respond to medical therapy and nonsurgical options, but it is not uncommon for patients to require surgical intervention. Sacral nerve stimulation (SNS) presents an alternative for patients with bowel dysfunction combining proven therapeutic benefits and limited surgical risks. Here we describe the common indications for SNS, patient selection, technical details of the procedure, published outcomes, and complications that can arise. Based on our review, SNS is an effective treatment option for fecal incontinence and may reduce the patients' clinical symptoms and help restore their quality of life. Future research studies may expand the role of this modality for other bowel disorders.

Frequency of lower urinary tract injury after gastrointestinal surgery in the nationwide inpatient sample database.

Bladder and ureteral injury are serious iatrogenic complications during abdominal and pelvic surgery but are poorly investigated in the general surgery literature. The objective of this study was to examine rates, trends, and patient and surgical characteristics present in lower urinary tract injuries during gastrointestinal surgery using the Nationwide Inpatient Sample (NIS) database. The NIS database was queried from 2002 to 2010 for gastrointestinal surgery procedures including small/large bowel, rectal surgery, and procedures involving a combination of the two. These were crossreferenced with bladder and ureteral injury using International Classification of Diseases, 9th Revision, Clinical Modification codes. Multivariate regression analysis was used to calculate odds ratios for hypothesized risk factors. From 2002 to 2010, total average rates of bladder injury and ureteral injury were 0.15 and 0.06 per cent, respectively. Small/large bowel procedures had lower annual rates of ureteral (0.05 to 0.07%) and bladder (0.12 to 0.14%) injuries compared with ureteral (0.11 to 0.25%) and bladder (0.27 to 0.41%) injuries in rectal procedures. Presence of metastatic disease was associated with the greatest risk for bladder (odds ratio, 2.0; 95% confidence interval, 1.8 to 2.2) and ureteral (2.2; 1.9 to 2.5) injury in small/large bowel surgery, and for bladder (3.1; 2.5 to 3.9) and ureteral (4.0; 3.2 to 5.0) injury in combination procedures. Injury rates were significantly greater in open surgeries compared with laparoscopic procedures for both bladder injury (0.78 vs 0.26%, P < 0.0001) and ureteral injury (0.34 vs 0.06%, P < 0.0001). The incidence of genitourinary (GU) injury in gastrointestinal surgery is rare, less than 1.0 per cent, and is less than the incidence of GU injury reported in gynecologic surgery. This risk is increased by operations on the rectum and the presence of malignancy.

Cholecystitis.

Acute cholecystitis is defined as inflammation of the gallbladder and is usually caused by obstruction of the cystic duct. Cholescintigraphy is the most sensitive imaging modality for cholecystitis. The gold standard treatment of acute cholecystitis is laparoscopic cholecystectomy. Operating early in the disease course decreases overall hospital stay and avoids increased complications, conversion to open procedures, and mortality. Cholecystitis during pregnancy is a challenging problem for surgeons. Operative intervention is generally safe for both mother and fetus, given the improved morbidity of the laparoscopic approach compared with open, although increased caution should be exercised in women with gallstone pancreatitis.

Expression of RORγt marks a pathogenic regulatory T cell subset in human colon cancer.

The role of regulatory T cells (T(regs)) in human colon cancer (CC) remains controversial: high densities of tumor-infiltrating T(regs) can correlate with better or worse clinical outcomes depending on the study. In mouse models of cancer, T(regs) have been reported to suppress inflammation and protect the host, suppress T cells and protect the tumor, or even have direct cancer-promoting attributes. These different effects may result from the presence of different T(reg) subsets. We report the preferential expansion of a T(reg) subset in human CC with potent T cell-suppressive, but compromised anti-inflammatory, properties; these cells are distinguished from T(regs) present in healthy donors by their coexpression of Foxp3 and RORγt. T(regs) with similar attributes were found to be expanded in mouse models of hereditary polyposis. Indeed, ablation of the RORγt gene in Foxp3(+) cells in polyp-prone mice stabilized T(reg) anti-inflammatory functions, suppressed inflammation, improved polyp-specific immune surveillance, and severely attenuated polyposis. Ablation of interleukin-6 (IL-6), IL-23, IL-17, or tumor necrosis factor-α in polyp-prone mice reduced polyp number but not to the same extent as loss of RORγt. Surprisingly, loss of IL-17A had a dual effect: IL-17A-deficient mice had fewer polyps but continued to have RORγt(+) T(regs) and developed invasive cancer. Thus, we conclude that RORγt has a central role in determining the balance between protective and pathogenic T(regs) in CC and that T(reg) subtype regulates inflammation, potency of immune surveillance, and severity of disease outcome.

Development of a feasible transrectal natural orifice transluminal endoscopic surgery (NOTES®) approach in a cadaveric appendectomy model: anterior is better.

BACKGROUND: The transrectal natural orifice transluminal endoscopic surgery (NOTES) approach is a potentially promising alternative to transgastric or transvaginal approaches for intraperitoneal procedures. However, whether the optimal transrectal approach for intraperitoneal surgery is anterior or posterior remains unknown. To evaluate this, a prospective comparison of anterior and posterior transrectal NOTES approaches in a cadaveric appendectomy model was performed. METHODS: Operations were performed on human cadavers using a transanal endoscopic microsurgery (TEM) scope to assist with access and closure. Posterior access was achieved by tunneling cephalad through the retrorectal space into the peritoneal cavity. Anterior transrectal access was established through the rectal wall just above the peritoneal reflection. A dual-channel flexible endoscope was used to perform appendectomies. Rectotomies were closed using sutures or staples. Operative time, degree of laparoscopic assistance, complications, and leak-testing results were recorded. RESULTS: This study investigated 10 cadavers with access and closure attempted using both anterior (n = 10) and posterior (n = 5) approaches, whereas appendectomies were performed using either an anterior (n = 8) or a posterior (n = 2) approach. The anterior approach required less time than the posterior approach for peritoneal access (4 ± 1 vs. 61 ± 14 min; p < 0.001), specimen extraction (2 ± 1 vs. 5 ± 1 min; p < 0.01), and the total operation (99 ± 35 vs. 176 ± 26 min; p = 0.02). A "pure" NOTES dissection was possible with the anterior approach using rigid transanal instruments for assistance. Dissection time, closure time, and the incidence of complications were similar between the two approaches. Leak testing of closures showed significant variability for all closure types. CONCLUSION: Transrectal NOTES appendectomy is feasible in a cadaveric model using an anterior transrectal approach. This approach is technically easier, results in shorter operative times, and allows for a "pure" NOTES dissection compared with a posterior transrectal approach. Leak pressure testing of NOTES closures is unreliable in the cadaveric model.

Progression to advanced neoplasia is infrequent in post colectomy familial adenomatous polyposis patients under endoscopic surveillance.

BACKGROUND AND STUDY AIMS: Advanced neoplasia may occur in the remaining colon and distal ileum of familial adenomatous polyposis (FAP) patients who have had a prophylactic colon resection. The role of post operative lower GI endoscopic surveillance and management of advanced neoplasia in FAP patients is not well defined. The aims of this study were to determine the prevalence of post operative neoplasia and to evaluate the safety and effectiveness of lower GI endoscopic surveillance and ablative therapy following prophylactic colon resection. PATIENTS AND METHODS: A retrospective analysis of 42 FAP patients with prior primary colon cancer preventative surgery undergoing lower GI surveillance and ablative therapy from 1992 to 2006. RESULTS: All patients had adenomatous disease identified upon initial endoscopy with advanced neoplasia identified in 6/42 (14%). Patients had a median of 4 endoscopic procedures of which 2 (range 0-12) were therapeutic, over a 49 month follow-up period (range 0-168) Thermal ablation with argon plasma coagulation, polypectomy and surgical intervention were required in 55%, 7% and 14% of patients. Ablative therapy complications were due to Nd: YAG laser and snare polypectomy (5%). Progression to advanced neoplasia from baseline pathology occurred despite ablative therapy in 3/42 (7%) patients. We propose a lower GI tract endoscopic surveillance program for post surgical FAP patients. CONCLUSION: Despite prophylactic colon surgery, FAP patients continue to be at risk of neoplasia. The development of advanced neoplasia is infrequent in patients embarking upon endoscopic surveillance. Ablative therapy is effective and safe for the vast majority of FAP patients.

Impact of pre- and postoperative multimodality therapy on rectal cancer.

Surgery is the primary treatment of rectal cancer. However, variability in surgical outcomes led to development of combined therapies including pelvic radiation and systemic chemotherapy. The evolution of these therapies both individually and combined, their successes and limitations is discussed in the context of an evolving understanding of rectal cancer biology. The impact of standardized optimal surgery on the need for additional therapy and trends in treating complete responders to neoadjuvant therapy is also reviewed.

The role of clinical trials in the development of novel surgical techniques.

The new paradigm and standard for medicine and surgery is the evidence-based practice for which the randomized controlled trial is fundamental. Despite the early involvement of surgeons in clinical trials, randomized trials testing novel surgical therapies are not common. Indeed, only 24% of surgical patients are managed based on level 1 evidence. This chapter details how randomized controlled trial methodologies facilitate the development of level 1 evidence in support of minimally invasive colon cancer surgery.

Colon and rectal cancer: laparoscopic or open?

Early experiences with laparoscopic colectomy were unfavorable, with higher than expected rates of wound tumor implants and concerns about short and long-term compromised oncologic outcomes. Several international randomized controlled trials were initiated to address concerns regarding compromised oncologic outcomes. Each of the trials was designed to test the hypothesis that level 1 evidence supports the general feasibility and recovery advantage as well as cancer equivalence of laparoscopic colectomy in curable colon cancer. The following four phase III randomized controlled trials have completed accrual and reported early data on recovery benefits for laparoscopic colectomy: Barcelona, Clinical Outcomes of Surgical Therapy Study Group (COSTSG), Colon Cancer Laparoscopic or Open Resection (COLOR), and Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC). These trials have uniformly and consistently shown a significant reduction in the use of narcotics and oral analgesics and length of hospital stay, as well as a faster return of diet and bowel function, with laparoscopic colectomy. Two of the trials, Barcelona and COSTSG, have sufficient maturation and follow-up to report recurrence and survival data, and neither has found a survival disadvantage in patients treated with laparoscopic colectomy. Results of the Barcelona trial suggest a cancer-related survival advantage in patients treated with laparoscopic colectomy, based solely on differences in patients with stage III disease; this is not confirmed by the COSTSG trial. Results of the CLASICC and COLOR trials, as well as 5-year data from the COSTSG trial, should definitively address survival results. The investigational experience with laparoscopic rectal cancer is not as mature; the subset of rectal cancer patients (n = 253) in the CLASICC trial provides the only available randomized controlled trial data. Laparoscopic colectomy in patients with curable cancer is accepted as an alternative to open colectomy, whereas the viability of laparoscopic rectal cancer resection requires further investigation.

Minimal access cancer management.

Minimal access approaches in the treatment of a variety of solid tumors of the stomach, large bowel, and genitourinary system are now being advocated in several surgical specialty areas. The laparoscope has evolved from a diagnostic tool to a modality that allows for removal of tumors using small incisions and the application of pneumoperitoneum with carbon dioxide. Through studies using animal models and patient investigation, the immunologic benefits of laparoscopic cancer procedures appear to be beneficial when compared with conventional laparotomy. Overall benefits of analgesic reduction, more rapid postoperative recovery, and patient satisfaction are the byproducts of minimal access approaches. Patients with cancers of the stomach, colon, and kidney show similar long-term outcomes when compared with conventional open techniques. Caution, however, should be exercised in recommending laparoscopic approaches for routine management of primary tumors of the rectum and adrenal gland.

Laparoscopic restorative proctocolectomy for ulcerative colitis.

Laparoscopic surgery of the colon has become an established method for the resection of both benign and malignant disease. Complex laparoscopic colon resections were once stigmatized due to their longer operating times and inherent technical difficulty. However, technological innovations and increased surgical experience with laparoscopy have advanced the field of complex laparoscopic surgery, including ileal pouch-anal anastomosis (IPAA) procedure, with safe feasible results. When these operations are broken down in a stepwise fashion, the complexity of the laparoscopic IPAA procedure becomes simplified, allowing one to effectively reproduce this operation. The systematic laparoscopic steps outlined establish a simple, reproducible approach to a laparoscopic IPAA procedure for ulcerative colitis patients. This approach to laparoscopic IPAA provides one with a viable approach to this complex operation.