Sixty years in the making: collagenase Clostridium histolyticum, from benchtop to FDA approval and beyond.

PURPOSE: The introduction of collagenase Clostridium histolyticum (CCH) as the first and only FDA-approved non-surgical treatment for Peyronie's disease (PD) has been an important step in its management. Our aim is to provide an overview of the historical origins of CCH and its development through FDA approval and beyond for the treatment of PD. METHODS: A PubMed search using the terms Peyronie OR Peyronie's AND collagenase and limited to clinical research studies resulted in 24 articles that were examined for the current review. RESULTS: PD is a connective tissue disorder of the penile tunica albuginea involving fibrotic penile plaques that cause abnormal curvature and, in many cases, erectile pain. Although the exact mechanism and underlying pathophysiology are not well characterized, the known lability of these plaques to exogenous bacterial collagenase combined with a lack of effective medical therapies led to the development of CCH as an evidence-based treatment of PD. The initial discovery of collagenase was followed by in vitro studies on PD plaque tissue and following the phase 3 IMPRESS trial culminated in FDA approval of CCH in 2013. Future directions in CCH therapy include improved patient selection, use in acute phase PD, adjuvant and combination therapies, and novel delivery mechanisms. CONCLUSION: CCH provides an effective non-surgical treatment option for men with PD. We have traced the development of CCH in the treatment of PD from the earliest in vitro investigations to comprehensive multi-study meta-analyses confirming its highly rated efficacy when compared to other historical non-surgical remedies.

A modified technique for intralesional injection of collagenase Clostridium histolyticum for Peyronie's disease results in reduced procedural morbidity using a standardized hematoma classification rubric.

PURPOSE: Early clinical trials of injectable collagenase Clostridium histolyticum (CCh) for Peyronie's disease (PD) demonstrated safety and efficacy. Since then, modified injection protocols have been proposed. Adverse events-such as bruising, swelling, hematoma, and corporal rupture-exceed 50% in many studies, but lack of standardization of hematoma severity limits conclusions about the relative safety of protocols. We propose a modification of the standard injection technique that aims to decrease the rates of adverse events. We further describe a hematoma classification rubric that may standardize safety assessment. METHODS: A modified injection procedure, termed the "fan" technique, was employed in the treatment of PD. All men receiving CCh from January 2016 through January 2019 at a single institution were included in an institutional review board (IRB) approved database. Treatment outcomes and adverse events were retrospectively assessed. A three-tiered hematoma classification rubric was devised to standardize reporting of hematoma, which was defined as concurrent bruising and swelling at the site of injection without loss of erection. RESULTS: Using the fan technique, 152 patients received 1323 injections. Eight hematomas (5.3% of all patients, 0.6% of all injections) were observed. The number of grade I, grade II, and grade III hematomas were 3, 2, and 3, respectively. Bruising or swelling not meeting the definition of hematoma was seen in 54.6% and 27.0% of patients, respectively. There were zero corporal ruptures. CONCLUSION: A modified injection technique results in reduced procedural morbidity. A hematoma classification system provides clarity and standardization to the assessment of safety in PD treatment. Further clinical studies with control arms are required to verify these findings.

Laparoscopic loop ileostomy reversal with intracorporeal anastomosis is associated with shorter length of stay without increased direct cost.

BACKGROUND: Laparoscopic ileostomy closure with intracorporeal anastomosis offers potential advantages over open reversal with extracorporeal anastomosis, including earlier return of bowel function and reduced postoperative pain. In this study, we aim to compare the outcome and cost of laparoscopic ileostomy reversal (utilizing either intracorporeal or extracorporeal anastomosis) with open ileostomy reversal. METHODS: A retrospective review of sequential patients undergoing elective loop ileostomy reversal between 2013 and 2016 at a single, high-volume institution was performed. Patients were stratified on the basis of operative approach: open reversal, laparoscopic-assisted reversal with extracorporeal anastomosis (LE), and laparoscopic reversal with intracorporeal anastomosis (LI). Linear and logistic regressions were utilized to perform multivariate analysis and determine risk-adjusted outcomes. RESULTS: Of 132 sequential cases of loop ileostomy reversal, 50 (38%) underwent open, 49 (37%) underwent LE, and 33 (22%) underwent LI. Demographic data and preoperative comorbidities were similar between the three cohorts. Median length of stay was significantly shorter for LI (52.1 h, p < 0.05) compared to open (69.0 h) and LE (69.6 h). After risk-adjusted analysis, length of stay was significant shorter in LI compared to LE (GM 0.78, 95% CI 0.64-0.93, p < 0.01) and open reversal (GM 0.78, 95% CI 0.66-0.93, p < 0.01). Risk-adjusted 30-day morbidity rates were similar for LI compared to LE (OR 0.43, 95% CI 0.081-2.33, p = 0.33) and open reversal (OR 0.53, 95% CI 0.09-3.125, p = 0.48). Median in-hospital direct cost was similar for LI ($6575.00), LE ($6722.50), and open reversal ($6181.00). CONCLUSION: Laparoscopic ileostomy reversal with intracorporeal anastomosis was associated with shorter length of stay without increased overall direct cost. The technique of laparoscopic ileostomy reversal warrants continued study in a randomized clinical trial.

An endoscopic mucosal grading system is predictive of leak in stapled rectal anastomoses.

BACKGROUND: Anastomotic leak is a devastating postoperative complication following rectal anastomoses associated with significant clinical and oncological implications. As a result, there is a need for novel intraoperative methods that will help predict anastomotic leak. METHODS: From 2011 to 2014, patient undergoing rectal anastomoses by colorectal surgeons at our institution underwent prospective application of intraoperative flexible endoscopy with mucosal grading. Retrospective review of patient medical records was performed. After creation of the colorectal anastomosis, application of a three-tier endoscopic mucosal grading system occurred. Grade 1 was defined as circumferentially normal appearing peri-anastomotic mucosa. Grade 2 was defined as ischemia or congestion involving <30% of either the colon or rectal mucosa. Grade 3 was defined as ischemia or congestion involving >30% of the colon or rectal mucosa or ischemia/congestion involving both sides of the staple line. RESULTS: From 2011 to 2014, a total of 106 patients were reviewed. Grade 1 anastomoses were created in 92 (86.7%) patients and Grade 2 anastomoses were created in 10 (9.4%) patients. All 4 (3.8%) Grade 3 patients underwent immediate intraoperative anastomosis takedown and re-creation, with subsequent re-classification as Grade 1. Demographic and comorbidity data were similar between Grade 1 and Grade 2 patients. Anastomotic leak rate for the entire cohort was 12.2%. Grade 1 patients demonstrated a leak rate of 9.4% (9/96) and Grade 2 patients demonstrated a leak rate of 40% (4/10). Multivariate logistic regression associated Grade 2 classification with an increased risk of anastomotic leak (OR 4.09, 95% CI 1.21-13.63, P = 0.023). CONCLUSION: Endoscopic mucosal grading is a feasible intraoperative technique that has a role following creation of a rectal anastomosis. Identification of a Grade 2 or Grade 3 anastomosis should provoke strong consideration for immediate intraoperative revision.

Respiratory complications after colonic procedures in chronic obstructive pulmonary disease: does laparoscopy offer a benefit?

BACKGROUND: Patients with severe chronic obstructive pulmonary disease (COPD) are at a higher risk for postoperative respiratory complications. Despite the benefits of a minimally invasive approach, laparoscopic pneumoperitoneum can substantially reduce functional residual capacity and raise alveolar dead space, potentially increasing the risk of respiratory failure which may be poorly tolerated by COPD patients. This raises controversy as to whether open techniques should be preferentially employed in this population. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database from 2011 to 2014 was used to examine the clinical data from patients with COPD who electively underwent laparoscopic and open colectomy. Patients defined as having COPD demonstrated either functional disability, chronic use of bronchodilators, prior COPD-related hospitalization, or reduced forced expiratory reserve volumes on lung testing (FEV1 <75%). Demographic data and preoperative characteristics were compared. Linear and logistic regressions were utilized to perform multivariate analysis and determine risk-adjusted outcomes. RESULTS: Of the 4397 patients with COPD, 53.8% underwent laparoscopic colectomy (LC) while 46.2% underwent open colectomy (OC). The LC and OC groups were similar with respect to demographic data and preoperative comorbidities. Equivalent frequencies of exertional dyspnea (LC 35.4 vs OC 37.7%, P = 0.11) were noted. After multivariate risk adjustment, OC demonstrated an increased rate of overall respiratory complications including pneumonia, reintubation, and prolonged ventilator dependency when compared to LC (OR 1.60, 95% CI 1.30-1.98, P < 0.01). OC was associated with longer length of stay (10 ± 8 vs. 6.7 ± 7 days, P < 0.01) and higher readmission (OR 1.36, 95% CI 1.09-1.68, P < 0.01) compared to LC. CONCLUSION: Despite the potential risks of laparoscopic pneumoperitoneum in the susceptible COPD population, a minimally invasive approach was associated with lower risk of postoperative respiratory complications, shorter length of stay, and decrease in postoperative morbidity.

Defining the Role of Minimally Invasive Proctectomy for Locally Advanced Rectal Adenocarcinoma.

OBJECTIVE: National examination of open proctectomy (OP), laparoscopic proctectomy (LP), and robotic proctectomy (RP) in pathological outcomes and overall survival (OS). BACKGROUND: Surgical management for rectal adenocarcinoma is evolving towards utilization of LP and RP. However, the oncological impacts of a minimally invasive approach to rectal cancer have yet to be defined. METHODS: Retrospective review of the National Cancer Database identified patients with nonmetastatic locally advanced rectal adenocarcinoma from 2010 to 2014, who underwent neoadjuvant chemoradiation, surgical resection, and adjuvant therapy. Cases were stratified by surgical approach. Multivariate analysis was used to compare pathological outcomes. Cox proportional-hazard modeling and Kaplan-Meier analyses were used to estimate long-term OS. RESULTS: Of 6313 cases identified, 53.8% underwent OP, 31.8% underwent LP, and 14.3% underwent RP. Higher-volume academic/research and comprehensive community centers combined to perform 80% of laparoscopic cases and 83% of robotic cases. In an intent-to-treat model, multivariate analysis demonstrated superior circumferential margin negativity rates with LP compared with OP (odds ratio 1.34, 95% confidence interval 1.02-1.77, P = 0.036). Cox proportional-hazard modeling demonstrated a lower death hazard ratio for LP compared with OP (hazard ratio 0.81, 95% confidence interval 0.67-0.99, P = 0.037). Kaplan-Meier analysis demonstrated a 5-year OS of 81% in LP compared with 78% in RP and 76% in OP (P = 0.0198). CONCLUSION: In the hands of experienced colorectal specialists treating selected patients, LP may be a valuable operative technique that is associated with oncological benefits. Further exploration of pathological outcomes and long-term survival by means of prospective randomized trials may offer more definitive conclusions regarding comparisons of open and minimally invasive technique.

Comparison of Times to Ureteral Efflux after Administration of Sodium Fluorescein and Phenazopyridine.

PURPOSE: There is currently a national shortage of indigo carmine. In efforts to identify the most efficient aid for visualizing ureteral efflux intraoperatively we investigated the time to excretion of phenazopyridine vs a newly identified alternative, sodium fluorescein. MATERIALS AND METHODS: We analyzed prospectively collected data on a cohort of women who underwent pelvic reconstructive surgery in 2015. Per provider preference patterns a number of patients were administered 200 mg phenazopyridine orally with a sip of water 1 hour prior to the start of operative time. Other patients were given 0.5 ml 10% sodium fluorescein intravenously in the operating room. In all cases time was measured between the administration of the agent and the visualization of color changes consistent with agent efflux in an indwelling catheter, which was placed at the start of the operation. Differences in excretion times between the groups were compared with the Wilcoxon rank sum test. RESULTS: Seven women received phenazopyridine and 5 received sodium fluorescein. Mean excretion time was significantly longer in the phenazopyridine group compared to the sodium fluorescein group (81.9 vs 5.1 minutes, p = 0.0057). Median excretion time for phenazopyridine was 70 minutes (range 59 to 127) and for sodium fluorescein it was 5 minutes (range 3 to 9). CONCLUSIONS: Sodium fluorescein is excreted significantly faster in the operating room compared to phenazopyridine. Depending on the cost of these agents at an institution, in addition to the desire to decrease operative time, this may impact practice patterns and agent selection.

Incidence, Risk Factors, and Trends of Motor Peripheral Nerve Injury After Colorectal Surgery: Analysis of the National Surgical Quality Improvement Program Database.

BACKGROUND: Motor peripheral nerve injury is a rare but serious event after colorectal surgery, and a nationwide study of this complication is lacking. OBJECTIVE: The purpose of this study was to report the incidence, trends, and risk factors of motor peripheral nerve injury during colorectal surgery. DESIGN: The National Surgical Quality Improvement Program database was surveyed for motor peripheral nerve injury complicating colorectal procedures. Risk factors for this complication were identified using logistic regression analysis. SETTINGS: The study used a national database. PATIENTS: Patients undergoing colorectal resection between 2005 and 2013 were included. MAIN OUTCOME MEASURES: The incidence, trends, and risk factors for motor peripheral nerve injury complicating colorectal procedures were measured. RESULTS: We identified 186,936 colorectal cases, of which 50,470 (27%) were performed laparoscopically. Motor peripheral nerve injury occurred in 122 patients (0.065%). Injury rates declined over the study period, from 0.025% in 2006 to <0.010% in 2013 (p < 0.001). Patients with motor peripheral nerve injury were younger (mean ± SD; 54.02 ± 15.41 y vs 61.56 ± 15.95 y; p < 0.001), more likely to be obese (BMI ≥30; 43% vs 31%; p = 0.003), and more likely to have received radiotherapy (12.3% vs 4.7%; p < 0.001). Nerve injury was also associated with longer operative times (277.16 ± 169.79 min vs 176.69 ± 104.80 min; p < 0.001) and was less likely to be associated with laparoscopy (p = 0.043). Multivariate analysis revealed that increasing operative time was associated with nerve injury (OR = 1.04 (95% CI, 1.03-1.04)), whereas increasing age was associated with a protective effect (OR = 0.80 (95% CI, 0.71-0.90)). LIMITATIONS: This study was limited by its retrospective nature. CONCLUSIONS: Motor peripheral nerve injury during colorectal procedures is uncommon (0.065%), and its rate declined significantly over the study period. Prolonged operative time is the strongest predictor of motor peripheral nerve injury during colorectal procedures. Instituting and documenting measures to prevent nerve injury is imperative; however, special attention to this complication is necessary when surgeons contemplate long colorectal procedures.

Comparison of open, laparoscopic, and robotic approaches for total abdominal colectomy.

BACKGROUND: The utilization of minimally invasive surgery is increasing in colorectal surgery. We sought to compare the outcomes of patients who underwent elective open, laparoscopic, and robotic total abdominal colectomy. METHODS: The NIS database was used to examine the clinical data of patients who underwent an elective total colectomy procedure during 2009-2012. Multivariate regression analysis was performed to compare the three surgical approaches. RESULTS: We sampled a total of 26,721 patients who underwent elective total colectomy. Of these, 16,780 (62.8 %) had an open operation, while 9934 (37.2 %) had a minimally invasive approach (9614 laparoscopic surgery, and 326 robotic surgery). The most common indication for an operation was ulcerative colitis (31 %). Patients who underwent open surgery had significantly higher mortality and morbidity compared to laparoscopic (AOR 2.48, 1.30, P < 0.01) and robotic approaches (AOR 1.04, 1.30, P < 0.01 and P = 0.04, respectively). There was no significant difference in mortality and morbidity between the laparoscopic and robotic approaches (AOR 0.96, 1.03, P = 0.10, P = 0.78). However, conversion rate of laparoscopic surgery to open was significantly higher than that of robotic approach (13.3 vs. 1.5 %, P < 0.01). Patients who underwent laparoscopic surgery had significantly lower total hospital charges compared to patients who underwent open surgery (mean difference = $21,489, P < 0.01). Also, total hospital charges for a robotic approach were significantly higher than for a laparoscopic approach (mean difference = $15,595, P < 0.01). CONCLUSION: Minimally invasive approaches to total colectomy are safe, with the advantage of lower mortality and morbidity compared to an open approach. Although there was no significant difference in the morbidity between minimally invasive approaches, robotic surgery had a significantly lower conversion rate compared to laparoscopic approach. Total hospital charges are significantly higher in robotic surgery compared to laparoscopic approach.

Trends in colorectal cancer admissions and stage at presentation: impact of screening.

BACKGROUND: Colorectal cancer (CRC) incidence is rising among patients under age 50. As such, we set out to determine the proportion of CRC-related hospital admissions and distribution of colon cancer by stage in different age groups. METHODS: The NIS database for 2002-2012 was used to investigate trends of colorectal cancer resection by age, and the ACS NSQIP database for 2012-2013 was used to investigate contemporary stage at diagnosis for colon cancer in different age groups. RESULTS: A total of 1,198,421 patients were admitted to a hospital with a diagnosis of CRC and captured by the NIS database. Although the number of hospitalized CRC patients decreased from 2002 to 2012, the observed decrease was predominant in patients older than 65 years (P < 0.01) and in colon cancer compared to rectal cancer patients (P < 0.01). The proportion of patients younger than 65 years increased from 32.8 % in 2002 to 41.1 % in 2012, and the proportion of patients under age 50 increased from 9 to 12 %. In the NSQIP database, the age <50 group also had a significantly higher proportion of advanced disease (stage III/IV) compared to patients age 50 and older (62.3 vs. 47.5 %, P < 0.01). In 2012, it was observed that most patients with rectal cancer were younger than 65 years (55.8 %). CONCLUSION: There was a steady decrease in the number of hospitalized patients with colorectal cancer during the last decade, primarily attributable to a decrease in the older than 65 years age patients and colon cancer patients. The proportion of hospitalized patients age <50 is rising. In addition, patients younger than 50 years were more likely to have advanced disease compared to older patients.

Laparoscopic right hemicolectomy: short- and long-term outcomes of intracorporeal versus extracorporeal anastomosis.

BACKGROUND: The use of laparoscopy for right hemicolectomy has gained popularity allowing the option of a totally laparoscopic intracorporeal anastomosis (IA) for intestinal reconstruction. This technique may alleviate some of the technical limitations that a surgeon faces with a laparoscopic-assisted extracorporeal anastomosis (EA). METHODS: A retrospective chart review of 195 consecutive patients who underwent laparoscopic right hemicolectomy by four colorectal surgeons at three institutions from March 2005 to June 2014 was performed. Multivariate regression analysis was used to compare postoperative and oncologic outcomes. RESULTS: A total of 195 patients underwent laparoscopic right hemicolectomy over the study period, with 86 (44 %) patients receiving IA and 109 (56 %) patients receiving an EA. The most common indication for surgery in both groups was cancer: 56 (65 %) of IA cases and 57 (52 %) of EA cases. IA had a significantly higher rate of minor complications but no difference in serious complications compared to EA. Conversion to open resection was higher in EA. Using multivariate analysis to compare IA versus EA, there was no significant difference in length of stay, return of bowel function, risk of anastomotic leak, risk of intraabdominal abscess or risk of wound complications. Amongst cancer resections, there was no significant difference in the median number of lymph nodes harvested (18 LNs in IA group vs. 19 LNs in EA group, P > 0.05). There was also no significant difference in overall survival and disease-free survival at 5.7 years between the two groups. CONCLUSIONS: IA in laparoscopic right hemicolectomy is associated with similar postoperative and oncologic outcomes compared to EA. IA may possess advantages in terms of conversion and flexibility of specimen extraction, but this is counterbalanced by a higher incidence of minor complications. These findings suggest that IA represents a valid technique in the arsenal of the experienced colorectal surgeon without compromising outcomes.

Risk factors for prolonged ileus following colon surgery.

BACKGROUND: Prolonged ileus is one of the most common postoperative complications after colorectal surgery. We sought to investigate the predictors of prolonged ileus following elective colon resections procedures. METHODS: The national participant user files of NSQIP databases were utilized to examine the clinical outcomes of patients undergoing elective colon resection during 2012-2013. Multivariate regression analysis was performed to investigate predictors of prolonged ileus. Prolonged ileus was defined as no return of bowel function in 7 days. RESULTS: We sampled a total of 27,560 patients who underwent colon resections; of these, 3497 (12.7%) patients had prolonged ileus. Patients with ileocolonic anastomosis (ICA) had a significantly higher rate of prolonged ileus compared to patients with colorectal anastomosis (CRA) (15 vs. 11.5%, AOR 1.25, P < 0.01). Prolonged ileus was significantly associated with intra-abdominal infections (13 vs. 2.8%, AOR 2.56, P < 0.01) and anastomotic leakage (12 vs. 2.4%, AOR 2.50, P < 0.01). Factors such as preoperative sepsis (AOR 1.63, P < 0.01), disseminated cancer (AOR 1.24, P = 0.01), and chronic obstructive pulmonary disease (AOR 1.27, P = 0.02) were associated with an increased risk of prolonged ileus, whereas oral antibiotic bowel preparation (AOR 0.77, P < 0.01) and laparoscopic surgery (AOR 0.51, P < 0.01) are associated with decreased prolonged ileus risk. CONCLUSIONS: Prolonged ileus is a common condition following colon resection, with an incidence of 12.7%. Among colon surgeries, colectomy with ICA resulted in the highest rate of postoperative prolonged ileus. Prolonged ileus is positively associated with anastomotic leak and intra-abdominal infections; thus, a high index of suspicion must be had in all patients with prolonged postoperative ileus.

Post-Hospital Discharge Venous Thromboembolism in Colorectal Surgery.

BACKGROUND: There are limited data regarding the criteria for prophylactic treatment of venous thromboembolism (VTE) after hospital discharge. We sought to identify risk factors of post-hospital discharge VTE events following colorectal surgery. METHODS: The NSQIP database was utilized to examine patients developed VTE after hospital discharge following colorectal surgery during 2005-2013. Multivariate analysis using logistic regression was performed to quantify risk factors of VTE after discharge. RESULTS: We evaluated a total of 219,477 patients underwent colorectal resections. The overall incidence of VTE was 2.1 % (4556). 33.8 % (1541) of all VTE events occurred after hospital discharge. The length of postoperative hospitalization had a strong association with post-discharge VTE, with the highest risk in patients who were hospitalized for more than 1 week after operation (AOR 9.08, P < 0.01). Other factors associated with post-discharge VTE included chronic steroid use (AOR 1.81, P < 0.01), stage 4 colorectal cancer (AOR 1.40, P = 0.03), obesity (AOR 1.37, P < 0.01), age >70 (AOR 1.21, P = 0.04), and open surgery (AOR 1.36, P < 0.01). Patients who were hospitalized for more than 1 week after an open colorectal resections had a 12 times higher risk of post-discharge VTE event compared to patients hospitalized less than 4 days after a laparoscopic resection (AOR 12.34, P < 0.01). CONCLUSIONS: VTE is uncommon following colorectal resections; however, a significant proportion occurs after patients are discharged from the hospital (33.8 %). The length of postoperative hospitalization appears to have a strong association with post-discharge VTE. High-risk patients may benefit from continued VTE prophylaxis after discharge.

Variations in Laparoscopic Colectomy Utilization in the United States.

BACKGROUND: Recent published articles reported a wide geographic variation in the utilization of laparoscopic colectomy in the United States. OBJECTIVES: This study aimed to report the current rates of laparoscopic colon resection in different types of hospitals in the United States. DESIGN: The Nationwide Inpatients Sample database was used to examine the clinical data of patients undergoing elective colon resection for the diagnosis of colon cancer or diverticular disease from 2009 to 2012. SETTING: Multivariate regression analysis was performed to compare different hospital types and regions regarding the utilization of laparoscopy. PATIENTS: Patients undergoing elective colon resection for the diagnosis of colon cancer or diverticular disease from 2009 to 2012 were selected. MAIN OUTCOME MEASURES: The primary outcome measured was the rates of laparoscopic colon resection in different types of hospitals. RESULTS: We sampled a total of 309,816 patients who underwent elective colon resection. Of these, 171,666 (55.4%) had a laparoscopic operation. The utilization of a laparoscopic approach increased from 51.3% in 2009 to 59.3% in 2012. The increased utilization of a laparoscopic approach was seen in both urban (53.6% vs 61.6%) and rural hospitals (33.4% vs 42.3%), for colon cancer (45% vs 53.5%), and diverticular disease (61.9% vs 68.2%). The conversion rate to open surgery for diverticular disease was significantly higher than for colon cancer (adjusted odds ratio (AOR), 1.23; p < 0.01). After adjustment, urban hospitals (AOR, 2.13; p < 0.01), teaching hospitals (AOR, 1.13; p < 0.01), and large hospitals (AOR, 1.33; p < 0.01) had a greater utilization of laparoscopic surgery. LIMITATIONS: This study was limited by its retrospective nature. CONCLUSIONS: Although we have finally reached the point where a majority of patients undergoing an elective colectomy for diverticular disease and colon cancer receive a laparoscopic operation, there is wide variation in the implementation of laparoscopic surgery in colon resection in the United States. The utilization of a laparoscopic approach has associations with hospital factors such as size, teaching status of the hospital, and geographic location (urban vs rural).

Surgical site infection impact of pelvic exenteration procedure.

BACKGROUND: We sought to investigate morbidity and infectious complications following pelvic exenteration (PEx) and compare infectious complications of patients undergoing PEx and conventional rectal resections. METHODS: The NSQIP database was utilized to examine the clinical data of patients undergoing elective rectal resections during 2005-2013. Multivariate regression analysis was used to compare postoperative complications of patients who underwent PEx and proctectomy procedure. RESULTS: We sampled a total of 7,950 patients who underwent rectal resection. Of these, 303 (3.8%) patients underwent pelvic exenteration. Mortality, morbidity, and infectious complications of patients who underwent pelvic exenteration were 1.7%, 65.7%, and 42.6%, respectively. Patients who underwent PEx had a significantly higher rate of morbidity (AOR: 2.01, P < 0.01), overall infectious complications (AOR: 1.49, P < 0.01), hemorrhagic complications (AOR: 3.36, P < 0.01), and surgical site infections (SSI) (AOR: 1.23, P = 0.04) compared to patients who underwent proctectomy. Return to operation room (AOR: 4.99, P < 0.01), obesity (AOR: 1.43, P < 0.01), disseminated cancer (AOR: 1.30, P = 0.01) were significantly associated with SSI complications. CONCLUSION: Postoperative morbidity and infectious complication are significantly higher after PEx procedure. Return to operation room, obesity, and disseminated cancer are strongly associated with surgical site infections complications in rectal surgery. Specific consideration to infectious complications is recommended for these patients.

Colorectal surgery in Parkinson's disease--outcomes and predictors of mortality.

PURPOSE: Although diseases of the lower gastrointestinal tract are common in patients with Parkinson's disease, there is a paucity of data regarding postoperative outcomes after colorectal surgery. METHODS: The Nationwide Inpatient Sample database (2007-2011) was utilized to analyze outcomes in patients with Parkinson's disease (PD) undergoing colorectal surgery. Main outcomes were risk-adjusted inpatient morbidity, mortality, hospital charge, and length of hospital stay. RESULTS: A total of 6490 patients were identified. Utilization of laparoscopic surgery in Parkinson's patients has progressively increased in frequency over the latest 5 years analyzed. The most common diagnoses were colorectal malignancy (39 %) and intestinal obstruction (20 %). Right hemicolectomy (37 %) and sigmoidectomy (30 %) were the most common operations. Laparoscopy was used in 18 % of Parkinson's patients and most commonly in the elective setting. 54.3 % of Parkinson's patients had emergency surgery compared to 38.6 % in non-Parkinson's. Overall morbidity and mortality were significantly lower after laparoscopic surgery compared to open (20 vs. 25 % and 2.1 vs. 6.6 %, respectively). Length of stay was significantly shorter (OR -1.86; p < 0.01) for laparoscopic operations, but there were no significant differences in risk-adjusted outcomes between laparoscopic and open groups. CONCLUSION: PD patients have high rates of morbidity and mortality after colorectal surgery; this may be because more than half of all patients in this population undergo emergent surgery. The laparoscopic approach appears to have short-term benefits in this patient population.

Surgical treatments for rectal prolapse: how does a perineal approach compare in the laparoscopic era?

BACKGROUND: Patients with rectal prolapse often have significant comorbidities that lead surgeons to select a perineal resection for treatment despite a reported higher recurrence rate over abdominal approaches. There is a lack of data to support this practice in the laparoscopic era. The objective of this study was to evaluate if risk-adjusted morbidity of perineal surgery for rectal prolapse is actually lower than laparoscopic surgery. DESIGN: A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database as performed for patients undergoing surgical treatment of rectal prolapse between 2005 and 2011. Outcomes were analyzed according to procedure-type: laparoscopic rectopexy (LR), laparoscopic resection/rectopexy (LRR), open rectopexy (OR), open resection/rectopexy (ORR), and perineal resection (PR). A multivariate logistic regression was used to compare risk-adjusted morbidity and mortality between each procedure. Main outcome measures were 30-day morbidity and mortality. RESULTS: Among 3,254 cases sampled, a laparoscopic approach was used in 22 %, an open abdominal approach in 30 %, and PR in 48 %. Patients undergoing PR were older (76) and had a higher ASA (3) compared to laparoscopic (58, 2) and open abdominal procedures (58, 2). Risk-adjusted mortality could not be assessed due to a low overall incidence of mortality (0.01 %). Overall morbidity was 9.3 %. ORR was associated with a higher risk-adjusted morbidity compared to PR (OR: 1.89 CI (1.19-2.99), p = 0.03). There were no significant differences in risk-adjusted morbidity found between LR and LRR compared to PR (OR 0.44 CI (0.19-1.03), p = 0.18; OR 1.55 CI (0.86-2.77), p = 0.18). Laparoscopic cases averaged 27 min longer than open cases (p < 0.001). CONCLUSION: Laparoscopic rectal prolapse surgery has comparable morbidity and mortality to perineal surgery. A randomized trial is indicated to validate these findings and to assess recurrence rates and functional outcomes.

Wound Disruption Following Colorectal Operations.

OBJECTIVES: Postoperative wound disruption is associated with high morbidity and mortality. We sought to identify the risk factors and outcomes of wound disruption following colorectal resection. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database was used to examine the clinical data of patients who underwent colorectal resection from 2005 to 2013. Multivariate regression analysis was performed to identify risk factors of wound disruption. RESULTS: We sampled a total of 164,297 patients who underwent colorectal resection. Of these, 2073 (1.3 %) had wound disruption. Patients with wound disruption had significantly higher mortality (5.1 vs. 1.9 %, AOR: 1.46, P = 0.01). The highest risk of wound disruption was seen in patients with wound infection (4.8 vs. 0.9 %, AOR: 4.11, P < 0.01). A number of factors are associated with wound disruption such as chronic steroid use (AOR: 1.71, P < 0.01), smoking (AOR: 1.60, P < 0.01), obesity (AOR: 1.57, P < 0.01), operation length more than 3 h (AOR: 1.56, P < 0.01), severe Chronic Obstructive Pulmonary Disease (COPD) (AOR: 1.36, P < 0.01), urgent/emergent admission (AOR: 1.31, P = 0.01), and serum Albumin Level <3 g/dL (AOR: 1.27, P < 0.01). Laparoscopic surgery had significantly lower risk of wound disruption compared to open surgery (AOR: 0.61, P < 0.01). CONCLUSION: Wound disruption occurs in 1.3 % of colorectal resections, and it correlates with mortality of patients. Wound infection is the strongest predictor of wound disruption. Chronic steroid use, obesity, severe COPD, prolonged operation, non-elective admission, and serum albumin level are strongly associated with wound disruption. Utilization of the laparoscopic approach may decrease the risk of wound disruption when possible.

Risk factors for conversion of laparoscopic colorectal surgery to open surgery: does conversion worsen outcome?

INTRODUCTION: The utilization of laparoscopy in colorectal surgery is increasing. However, conversion to open surgery remains relatively high. OBJECTIVE: We evaluated (1) conversion rates in laparoscopic colorectal surgery; (2) the outcomes of converted cases compared with successful laparoscopic and open colorectal operations; (3) predictive risk factors of conversion of laparoscopic colorectal surgery to open surgery. METHODS: Using the National Inpatient Sample database, we examined the clinical data of patients who underwent colon and rectal resection from 2009 to 2010. Multivariate regression analysis was performed to identify factors predictive for conversion of laparoscopic to open operation. RESULTS: A total of 207,311 patients underwent intended laparoscopic colorectal resection during this period. The conversion rate was 16.6 %. Considering resection type and pathology, the highest conversion rates were observed in proctectomy (31.4 %) and Crohn's disease (20.2 %). Using multivariate regression analysis, Crohn's disease (adjusted odds ratio [AOR], 2.80), prior abdominal surgery (AOR, 2.45), proctectomy (AOR, 2.42), malignant pathology (AOR, 1.90), emergent surgery (AOR, 1.82), obesity (AOR, 1.63), and ulcerative colitis (AOR, 1.60) significantly impacted the risk of conversion. Compared with patients who were successfully completed laparoscopically, converted patients had a significantly higher complication rate (laparoscopic: 23 %; vs. converted: 35.2 % vs. open: 35.3 %), a higher in-hospital mortality rate (laparoscopic: 0.5 %; vs. converted: 0.6 %; vs. open: 1.7 %) and a longer mean hospital stay (laparoscopic: 5.4 days; vs. converted: 8.1 days; vs. open: 8.4 days); however, converted patients had better outcomes compared with the open group. CONCLUSIONS: The conversion rate in colorectal surgery was 16.6 %. Converted patients had significantly higher rates of morbidity and mortality compared to successfully completed laparoscopic cases, although lower than open cases. Crohn's disease, prior abdominal surgery, and proctectomy are the strongest predictors for conversion of laparoscopic to open in colorectal operations.