Patient-Reported Outcome Measures in Colorectal Surgery: Construction of Core Measures Using Open-Source Research Method.

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients' organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients' representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.

Lower GI Bleeding: An Update on Incidences and Causes.

Bleeding from the lower gastrointestinal tract represents a significant source of morbidity and mortality. The colon represents the vast majority of the location of bleeding with only a much smaller incidence occurring in the small intestine. The major causes of lower gastrointestinal bleeding (LGIB) are from diverticulosis, vascular malformations, and cancer. We discuss the incidence and causes of LGIB.

Prophylactic antibiotics for hemorrhoidectomy: are they really needed?

BACKGROUND: Hemorrhoidectomy is considered by many to be a contaminated operation that requires antibiotic prophylaxis to lower the incidence of surgical site infection. In reality, little evidence exists to either support or refute the use of antibiotic prophylaxis in this setting. OBJECTIVE: This study aimed to determine if antibiotic prophylaxis is associated with reduced incidence of postoperative surgical site infection following hemorrhoidectomy. DESIGN: This is a retrospective database review. SETTING: This study was conducted at multiple institutions. PATIENTS: All patients undergoing hemorrhoidectomy with minimum 3-month follow-up were included. MAIN OUTCOME MEASURES: The primary outcome measure was the incidence of postoperative surgical site infection. RESULTS: Eight hundred fifty-two patients met the inclusion criteria (50.1% female; mean age, 50.0 ± 13.7 years). The prevalence of preoperative risk factors for surgical site infection included 7.7% with a smoking history, 2.5% with diabetes mellitus, 0.8% receiving steroids, and 0.2% with Crohn's disease. Surgery was performed predominately for 3-column prolapsed internal and mixed internal/external hemorrhoidal disease. All surgeries performed were closed hemorrhoidectomies. Antibiotic prophylaxis was used in a fewer number of cases (41.3% vs 58.7%). Overall, there were only 12 documented postoperative infections identified, producing an overall incidence of 1.4%. Of those patients who developed postoperative surgical site infections, 9 (75%) did not receive antibiotic prophylaxis (p = 0.25). On multivariate regression analysis, no perioperative risk factor was associated with an increased risk of developing a posthemorrhoidectomy surgical site infection. Conversely, there were no adverse antibiotic-related complications such as Clostridium difficile colitis or antibiotic-associated diarrhea in those receiving antibiotic prophylaxis. LIMITATIONS: This study was limited by the retrospective nature of the analysis. CONCLUSIONS: Postoperative surgical site infection is an exceedingly rare event following hemorrhoidectomy. Antibiotic prophylaxis does not reduce the incidence of postoperative surgical site infection, and its routine use appears unnecessary.

Laparoscopy impacts outcomes favorably following colectomy for ulcerative colitis: a critical analysis of the ACS-NSQIP database.

INTRODUCTION: The surgical management of ulcerative colitis (UC) often involves complex operations. We investigated the outcome of patients who underwent surgery for UC by analyzing a nationwide database. METHODS: We queried the American College of Surgeons National Surgical Quality Improvement Program database (ACS-NSQIP, 2005-2008) for all UC patients who underwent colectomy. To analyze by operation, groupings included: partial colectomy (PC; n = 265), total abdominal colectomy (TAC; n = 232), total proctocolectomy with ileostomy (TPC-I; n = 134), and total proctocolectomy with ileal pouch-anal anastomosis (IPAA; n = 446) to analyze 30-day outcomes. RESULTS: From 1,077 patients (mean age, 44 years; 45 % female; 7 % emergent), a laparoscopic approach was used in 29.2 %, with rates increasing 8.5 % each year (18.5 % in 2005 to 41.3 % in 2008, P < 0.001). Complications occurred in 29 %, and laparoscopy was associated with a lower complication rate (21 vs. 32 % open, P < 0.001). On multivariate regression, postoperative complications increased when patients were not functionally independent [odds ratio (OR) = 3.2], had preoperative sepsis (OR = 2.0), or prior percutaneous coronary intervention (OR = 2.8). A laparoscopic approach was associated with a lower complication rate (OR = 0.63). When stratified by specific complications, laparoscopy was associated with lower complications, including superficial surgical site infections (11.4 vs. 6.7 %, P = 0.0011), pneumonia (2.9 vs. 0.6 %, P = 0.023), prolonged mechanical ventilation (3.9 vs. 1.3 %, P = 0.023), need for transfusions postoperatively (1.6 vs. 0 %, P = 0.016), and severe sepsis (2.9 vs. 1.0 %, P = 0.039). Laparoscopy was also was associated with a lower complication rate in TACs (41.7 vs. 18.8 %, P < 0.0001) and IPAA (29.9 vs. 18.2 %, P = 0.005) and had an overall lower mortality rate (0.2 vs. 1.7 %, P = 0.046). CONCLUSIONS: Results from a large nationwide database demonstrate that a laparoscopic approach was utilized in an increasing number of UC patients undergoing colectomy and was associated with lower morbidity and mortality, even in more complex procedures, such as TAC and IPAA.

Surgical residents and the adequacy of dictated operative reports.

INTRODUCTION: The surgeon's clinical note has been previously shown to poorly reflect both physician-centered and patient-centered outcomes. We hypothesized that dictated operative reports do not adequately demonstrate surgeons' workload, preoperative involvement, clinical decision-making, or core competencies. MATERIALS AND METHODS: We retrospectively reviewed operative reports in the month of January for the years 2007-2011. Operative reports were dictated by interns, residents (R1-R5), and surgical staff. All resident reports were approved by staff surgeons. We qualitatively assessed each for 15 items that encompassed physician-centered outcomes, patient-centered outcomes, and Joint Commission/Medicare-required fields. Groups were compared to each other with 1-way analysis of variance with Bonferroni correction. RESULTS: We reviewed 999 operative reports. Nearly every chart included an indication and preoperative and postoperative diagnoses. Only 57.3% listed whether or not there were any complications. Half recorded operative findings. The mean number of fields missed based on level of surgical training was R1: 4.83, R2: 4.46, R3: 3.68, R4: 3.35, R5: 3.29, and staff: 3.09. Interns and second-year residents missed significantly more data fields than upper-level residents and staff (P < 0.0001). Staff surgeons missed fewer data fields than third-year residents (P = 0.004). There was no statistical difference between R4, R5, and surgical staff (P > 0.999). CONCLUSIONS: The dictated operative report does not accurately document preoperative surgeon involvement, clinical decision-making, maintenance of core competencies, or full compliance with Joint Commission regulations. Focused education and enhanced staff oversight of junior-level dictated operative reports might be required to improve quality.

Historical and current trends in colon trauma.

The authors discuss the evolution of the evaluation and management of colonic trauma, as well as the debate regarding primary repair versus fecal diversion. Their evidence-based review covers diagnosis, management, surgical approaches, and perioperative care of patients with colon-related trauma. The management of traumatic colon injuries has evolved significantly over the past 50 years; here the authors describe a practical approach to the treatment and management of traumatic injuries to the colon based on the most current research. However, management of traumatic colon injuries remains a challenge and continues to be associated with significant morbidity. Familiarity with the different methods to the approach and management of colonic injuries will allow surgeons to minimize unnecessary complications and mortality.

Phenotypic subpopulations of metastatic colon cancer stem cells: genomic analysis.

BACKGROUND: Human cancer is characterized by high heterogeneity in gene expression, varieties of differentiation phenotypes and tumor-host interrelations. Growing evidence suggests that tumor-initiating, or cancer stem cells (CSCs), may also represent a heterogeneous population. The present study was undertaken to isolate and characterize the different phenotypic subpopulations of metastatic colon cancer and to develop a working colon CSC model for obtaining highly tumorigenic and clonogenic cells in sufficient numbers. MATERIALS AND METHODS: Different phenotypic cell subpopulations were isolated based on differential levels and patterns of expression of several stemness markers, including CD133, CD44, CD166 and CD49b. Stemness properties of isolated cells were tested by analysis of their ability to form floating colonospheres in vitro, to induce tumors in NOD/SCID mice after transplantation at relatively low cell numbers, and to produce progenitors of different phenotypes. RESULTS: The metastatic colon cancer HCT116 cell line, which expressed a majority of known CSC markers, closely resembling the patterns of expression in exfoliated peritoneal cells from several metastatic colon cancer patients, was selected as a reference material. Genome-wide microarray analysis (Affymetrix; DAVID) of CD133(high) CSC-enriched versus CSC-depleted cell populations revealed 4,351 differentially expressed genes with an overrepresentation of those responsible for apoptosis resistance, regulation of cell cycle, proliferation, stemness and developmental pathways. Simultaneous analysis of 84 stem cell- and metastasis-related genes with corresponding PCR arrays identified genes differentially expressed in several colon CSC phenotypic populations versus bulk tumor cells, and in relation to each other. It was found that colonospheres induced by tumorigenic cells with the highest expression of CD133 and those which were induced by CD133/CD44-negative cells possessed profoundly different stem cell-related gene expression profiles. CONCLUSION: The proposed approaches allow for reliable isolation and propagation of highly tumorigenic and clonogenic cells of different phenotypes. Genomic analysis of several candidate CSC phenotypic populations may contribute to the identification of novel targets for colon cancer stem cell-targeted drug development and treatment.

The impact of Model for End-Stage Liver Disease-Na in predicting morbidity and mortality following elective colon cancer surgery irrespective of underlying liver disease.

BACKGROUND: The Model for End-Stage Liver Disease Sodium Model (MELD-Na) is a validated scoring system that uses bilirubin, international normalized ratio, serum creatinine, and sodium to predict mortality in cirrhotic patients awaiting liver transplantation. The aim of this study was to identify the utility of MELD-Na to predict patient outcomes, with and without liver disease, after elective colon cancer surgery. METHODS: A review of the American College of Surgeons National Surgical Quality Improvement Program database (2005 to 2010) was conducted to calculate risk-adjusted 30-day outcomes using regression modeling. RESULTS: A total of 10,842 patients (mean age, 68 years; 51% women) were included. MELD-Na scores were higher in men (10.2 vs 9.1, P < .001) and in open procedures (9.9 vs 9.1, P < .001). The overall complication and mortality rates were 26.3% and 3.3%, respectively. Incremental increases in MELD-Na score correlated with a 1.2% increase in mortality and a 1.1% increase in complications. On multivariate analysis, complications increased with MELD-Na score (odds ratio [OR], 1.05 per 1 point increase; 95% confidence interval [CI], 1.038 to 1.066). MELD-Na score was also associated with increased mortality (OR, 1.13; 95% CI, 1.1 to 1.16), along with ascites (OR, 5.7; 95% CI, 3.7 to 8.8) and corticosteroids (OR, 2.1; 95% CI, 1.3 to 3.3). CONCLUSIONS: Elevated preoperative MELD-Na score is significantly associated with worse outcomes after elective resection for colon cancer.

Complications of colorectal anastomoses: leaks, strictures, and bleeding.

Intestinal anastomosis is an essential part of surgical practice, and with it comes the inherent risk of complications including leaks, strictures, and bleeding, which result in significant morbidity and occasional mortality. Understanding the myriad of risk factors and the strength of the data helps guide a surgeon as to the safety of undertaking an operation in which a primary anastomosis is to be considered. This article reviews the risk factors, management, and outcomes associated with anastomotic complications.

Endoscopy and polyps-diagnostic and therapeutic advances in management.

Despite multiple efforts aimed at early detection through screening, colon cancer remains the third leading cause of cancer-related deaths in the United States, with an estimated 51000 deaths during 2013 alone. The goal remains to identify and remove benign neoplastic polyps prior to becoming invasive cancers. Polypoid lesions of the colon vary widely from hyperplastic, hamartomatous and inflammatory to neoplastic adenomatous growths. Although these lesions are all benign, they are common, with up to one-quarter of patients over 60 years old will develop pre-malignant adenomatous polyps. Colonoscopy is the most effective screening tool to detect polyps and colon cancer, although several studies have demonstrated missed polyp rates from 6%-29%, largely due to variations in polyp size. This number can be as high as 40%, even with advanced (> 1 cm) adenomas. Other factors including sub-optimal bowel preparation, experience of the endoscopist, and patient anatomical variations all affect the detection rate. Additional challenges in decision-making exist when dealing with more advanced, and typically larger, polyps that have traditionally required formal resection. In this brief review, we will explore the recent advances in polyp detection and therapeutic options.

An NSQIP evaluation of practice patterns and outcomes following surgery for anorectal abscess and fistula in patients with and without Crohn's disease.

BACKGROUND: Patients with Crohn's disease (CD) are believed to have more aggressive anorectal abscess and fistula disease. We assessed the types of procedures performed and perioperative complications associated with the surgical management of anorectal abscess and fistula disease in patients with and without CD. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database (ACS-NSQIP, 2005-2010) was used to calculate 30-day outcomes using regression modeling, accounting for demographics, comorbidities and surgical procedures. ICD-9 codes for anorectal abscess or fistula were used for initial selection. Patients were then stratified, based on the presence or absence of underlying CD. Local procedures included incision and drainage of abscesses, fistulotomy and seton placement. Cutaneous fistulas were considered simple, while all others were classified as complex (-vaginal, -urethral and -vesical). RESULTS: A total of 7,218 patients (mean age 45 years; 64% male) met inclusion criteria, with underlying CD in 345 (4.8%). CD patients were more likely to have a seton placed (9.9 vs 8.2%, P < 0.001) and be on steroids (15.4 vs 4.3%, P < 0.001). Thirty-seven percent of CD patients underwent local procedures, while 46% had a proctectomy and 8% underwent diversion. Fistulotomy was more common in those without underlying CD (16 vs 11%, P < 0.001). The overall complication rate after local treatment was 4.9%, with no difference between patients with and without CD (7.7 vs 4.9%, P = 0.144). This was not affected by fistula type-simple (7.9 vs 3.9%, P = 0.194) vs complex (33 vs 7.1%, P = 0.21)-or when stratified by wound (3.8 vs 2.4%; P = 0.26) or systemic complications (3.8 vs 2.5%; P = 0.53). Yet, complications following emergency procedures were higher in patients with CD (21.4 vs 5.9%, P = 0.047). Factors significantly associated with increased complications were Crohn's disease (OR = 8.2), lack of functional independence (OR = 2.0), pre-operative weight loss (OR = 2.6) and pre-operative acute renal failure (OR = 5.6). Steroids were also associated with a 1.7-fold increase in complications, independent from CD. CONCLUSIONS: While most patients with anorectal abscess/fistula are treated with local procedures, proctectomy and diversion use is fairly common in those with underlying CD. Although complication rates following elective local procedures for anorectal abscess/fistula are similar in patients with and without CD, they are higher in patients on steroids and in CD patients undergoing emergent procedures.

Improved access and visibility during stapling of the ultra-low rectum: a comparative human cadaver study between two curved staplers.

BACKGROUND: The purpose of this study was to compare in human cadavers the applicability of a commonly used stapling device, the CONTOUR® curved cutter (CC) (Ethicon Endo-Surgery, Cincinnati, OH) to a newly released, curved stapler, the Endo GIA™ Radial Reload with Tri-Staple™ Technology (RR) (Covidien, New Haven, CT) METHODS: Four experienced surgeons performed deep pelvic dissection with total mesorectal excision (TME) of the rectum in twelve randomized male cadavers. Both stapling devices were applied to the ultra-low rectum in coronal and sagittal configurations. Extensive measurements were recorded of anatomic landmarks for each cadaver pelvis along with various aspects of access, visibility, and ease of placement for each device. RESULTS: The RR reached significantly lower into the pelvis in both the coronal and sagittal positions compared to the CC. The median distance from the pelvic floor was 1.0 cm compared to 2.0 cm in the coronal position, and 1.0 cm versus 3.3 cm placed sagitally, p < 0.0001. Surgeons gave a higher visibility rating with less visual impediment in the sagittal plane using the RR Stapler. Impediment of visibility occurred in only 10% (5/48) of RR applications in the coronal position, compared to a rate of 48% (23/48) using the CC, p = 0.0002. CONCLUSIONS: The RR device performed significantly better when compared to the CC stapler in regards to placing the stapler further into the deep pelvis and closer to the pelvic floor, while causing less obstructing of visualization.

Stapler access and visibility in the deep pelvis: A comparative human cadaver study between a computerized right angle linear cutter versus a curved cutting stapler.

PURPOSE: Distal rectal stapling is often challenging because of limited space and visibility. We compared two stapling devices in the distal rectum in a cadaver study: the iDrive™ right angle linear cutter (RALC) (Covidien, New Haven, CT) and the CONTOUR® curved cutter (CC) (Ethicon Endo-Surgery, Cincinnati, OH). METHODS: Twelve male cadavers underwent pelvic dissection by 4 surgeons. After rectal mobilization as in a total mesorectal excision, the staplers were applied to the rectum as deep as possible in both the coronal and sagittal positions. The distance from the pelvic floor was measured for each application. A questionnaire rated the visibility and access of the stapling devices. Measurements were taken between pelvic landmarks to see what anatomic factors hinder the placement of a distal rectal stapler. RESULTS: The median (range) distance of the stapler from the pelvic floor in the coronal position for the RALC was 1.0 cm (0-4.0) vs. 2.0 cm (0-5.0) for the CC, p = 0.003. In the sagittal position, the median distance was 1.6 cm (0-3.5) for the RALC and 3.3 cm (0-5.0) for the CC, p < 0.0001. The RALC scored better than the CC in respect to: 1. interference by the symphysis pubis, 2. number of stapler readjustments, 3. ease of placement in the pelvis, 4. impediment of visibility, 5. ability to hold and retain tissue, 6. visibility rating, and 7. access in the pelvis. A shorter distance between the tip of the coccyx and the pubic symphysis correlated with a longer distance of the stapler from the pelvic floor (p = 0.002). CONCLUSIONS: The RALC is superior to the CC in terms of access, visibility, and ease of placement in the deep pelvis. This could provide important clinical benefit to both patient and surgeon during difficult rectal surgery.

Clinical significance of telomerase activity in peritoneal disseminated cells: gastrointestinal cancers.

Early detection and accurate staging of gastrointestinal (GI) cancers are difficult. The aim of this study was to evaluate whether telomerase activity (TA) in exfoliated/disseminated epithelial cells could be used as a reliable marker for GI cancers. TA was evaluated with the real-time RTQ-TRAP in immunomagnetically sorted peritoneal epithelial cells from 60 patients undergoing surgical treatment. Thirty-two patients were clinically diagnosed with a variety of GI cancers: 1 had premalignant disease, 2 had history of GI cancers, and 25 patients were clinically negative for cancer. Here we report that all types and all cases of gastrointestinal cancers were telomerase positive, thereby demonstrating 100% sensitivity for cancer. Eighteen of 25 nonmalignant cases had undetectable levels of TA, 2 had low, and 5 of 25 expressed high TA levels. Because normal epithelial cells usually have low TA and a lesser tendency to exfoliate compared with cancer cells, it is of great importance to have close follow-up for these patients to exclude possible malignant disease. We conclude that RTQ-TRAP assessment of TA in immunomagnetically sorted peritoneal epithelial cells has 100% sensitivity and 100% negative predictive value for GI cancers, and therefore, can be considered as a valuable tool and useful addition to current standard diagnostic methods. Clinical significance of unusually high telomerase activity in some clinically negative for cancer cases requires further study.

Rectovaginal fistulas: current surgical management.

Rectovaginal fistulas represent an often devastating condition in patients and a challenge for surgeons. Successful management of this condition must take into account a variety of variables including the etiology, size, and location of the fistula. Etiologies include obstetrical trauma, inflammatory bowel disease, malignant processes, and complications of radiation therapy and surgery. Repair options include local repairs, tissue transfer techniques, and abdominal operations.