Predictors of mesh explantation after incisional hernia repair.

BACKGROUND: Prosthetic mesh used for incisional hernia repair (IHR) reduces hernia recurrence. Mesh infection results in significant morbidity and challenges for subsequent abdominal wall reconstruction. The risk factors that lead to mesh explantation are not well known. METHODS: This is a multisite cohort study of patients undergoing IHR at 16 Veterans Affairs hospitals from 1998 to 2002. RESULTS: Of the 1,071 mesh repairs, 55 (5.1%) had subsequent mesh explantation at a median of 7.3 months (interquartile range 1.4-22.2) after IHR with permanent mesh prosthesis. Infection was the most common reason for explantation (69%). No differences were observed by the type of repair. Adjusting for covariates, same-site concomitant surgery (hazard ratio [HR] = 6.3) and postoperative surgical site infection (HR = 6.5) were associated with mesh explantation. CONCLUSIONS: Patients undergoing IHR with concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. Permanent prosthetic mesh should be used with caution in this setting.

Hospital-level variability in incisional hernia repair technique affects patient outcomes.

BACKGROUND: Mesh placement during ventral incisional hernia repair has been shown to result in superior outcomes; however, significant variation persists in the adoption of this technique. We performed a multi-institutional study to understand how variation in surgical technique influences outcomes. METHODS: This study is a retrospective, facility-level analysis of incisional hernia repairs performed at 16 veteran's administration medical centers between 1997 and 2002. Operative notes and a postoperative course were physician-abstracted from the medical record. Hospital rates for the type of hernia repair, mesh placement, and recurrence were calculated. Spearman's correlation and generalized linear models were performed. RESULTS: A total of 1,612 incisional hernia repairs with a median follow-up of 66.2 months were included in the study. The mean rate of mesh implantation was 63.7% but ranged from 37.5% to 90%. The 5-year recurrence rate was 25.6% and ranged from 16.0% to 38.4%. The rate of mesh use for the incisional hernia repair at the hospital level was associated significantly with the hospital recurrence rate for all cases (R(2) = .27; P = .04) and elective cases (R(2) = .31; P = .02). For every 10% increase in the rate of mesh placement, a corresponding 3.1% decrease was noted in the recurrence rates (P = .001). The hospital rate of mesh use was not associated significantly with rates of complications or patient satisfaction. CONCLUSION: Hospitals that adopted a higher rate of mesh repair for incisional hernia repairs had lower recurrence rates. These data support that the efficacy of mesh repair previously proven in clinical trials is highly translatable to effective practice in the field. Continued studies on the attributable risk of complications to mesh placement are ongoing.

Long-term follow-up of technical outcomes for incisional hernia repair.

BACKGROUND: Incisional hernia repair (IHR) is plagued by high recurrence rates and lack of long-term outcomes data to guide repair technique. Mesh repair reduces recurrence rates but lacks standardization of technique. We investigated long-term outcomes of elective IHR, focusing on technical predictors of recurrence. STUDY DESIGN: This retrospective multicenter cohort study included elective IHR performed at 16 Veterans Affairs hospitals between 1997 and 2002. Hernia characteristics and operative details were abstracted from operative notes, and chart review was performed to identify recurrence and complications. Kaplan-Meier curves and Cox regression models were used to evaluate the effects of hernia characteristics and operative technique on recurrence. RESULTS: There were 1,346 elective IHRs, of which 22% were recurrent hernias. Repair technique was primary suture in 31%, open inlay or onlay mesh in 30%, open underlay in 30%, and laparoscopic in 9%. At median follow-up of 73.4 months, there were 383 recurrences (28.5%), 23 mesh removals (1.7%), and 7 enterocutaneous fistulas (ECF) (0.5%). On Cox regression modeling with adjustment for hernia and Veterans Affairs site characteristics, the effectiveness of mesh varied by position. Compared with suture repair, laparoscopic (hazard ratio = 0.49; 95% CI, 0.28-0.84) and open underlay mesh repair (hazard ratio = 0.72; 95% CI, 0.53-0.98) substantially reduced the recurrence risk, but onlay or inlay mesh repair did not. Mesh position did not affect mesh removal or ECF rates. CONCLUSIONS: Underlay technique, either laparoscopic or open, for mesh implantation during elective IHR substantially reduces the risk of recurrence, without increasing the risk of serious mesh infection or ECF.

Ex vivo sentinel lymph node mapping in patients undergoing proctectomy for rectal cancer.

PURPOSE: Controversy exists over the utility of sentinel lymph node mapping in the treatment of rectal cancer. The purpose of this study was to evaluate the use of ex vivo sentinel lymph node mapping in the setting of proctectomy for rectal cancer, with and without multilevel sectioning and immunohistochemistry. METHODS: A prospective phase 2 clinical study of subjects undergoing proctectomy for rectal cancer from 2003 to 2008 was conducted. Sentinel lymph node mapping was performed with ex vivo injection of isosulfan blue. Sentinel lymph nodes were examined by hematoxylin and eosin evaluation, and when the results were negative, they were examined by multilevel sectioning and immunohistochemistry. RESULTS: The study population consisted of 58 subjects; 88% received neoadjuvant therapy. Tumors were downstaged in 25 (49%) subjects receiving neoadjuvant therapy, 24% were clinical complete responders, and 20% were pathologic complete responders. The mean total lymph node harvest was 12.1 nodes per patient. Twenty-five subjects had positive nodal disease on final pathology. The sentinel lymph node detection rate was 85%, with a mean sentinel lymph node harvest of 2.2 nodes per subject. Fifteen (26%) subjects had sentinel lymph node nodal metastasis on routine hematoxylin and eosin examination. Neither multilevel sectioning nor immunohistochemistry evaluation improved detection of sentinel lymph node positivity. The accuracy of sentinel lymph node mapping was 71%, the sensitivity was 53%, the negative predictive value was 79%, and the false negative rate was 47%. Seven subjects were determined to have nodal disease only in the sentinel lymph node. CONCLUSION: Ex vivo sentinel lymph node mapping is feasible after proctectomy for rectal cancer but did not improve staging. Neither multilevel sectioning nor immunohistochemistry improved the sensitivity of sentinel lymph node mapping.

Multiple preoperative endoscopic interventions are associated with worse outcomes after laparoscopic Heller myotomy for achalasia.

BACKGROUND: The effect of preoperative pneumatic dilation or botulinum toxin injection on outcomes after laparoscopic Heller myotomy (LHM) for achalasia is unclear. We compared outcomes in patients with and without multiple preoperative endoscopic interventions. METHODS: This cohort study categorized achalasia patients undergoing first-time LHM by the number of preoperative endoscopic interventions: zero or one intervention vs. two or more interventions. Outcomes of interest included surgical failure (defined as the need for re-intervention), gastrointestinal symptoms, and health-related quality of life. Logistic regression modeling was performed to determine the independent effect of multiple preoperative endoscopic interventions on the likelihood of surgical failure. RESULTS: One hundred thirty-four patients were included; 88 (66%) had zero to one preoperative intervention, and 46 (34%) had multiple (more than one) interventions. The incidence of surgical failure was 7% in the zero to one intervention group and 28% in the more than one intervention group (p < 0.01). Greater improvements in gastrointestinal symptoms and health-related quality of life were seen in the zero to one intervention group. On logistic regression modeling, the likelihood of surgical failure was significantly higher in the more than one intervention group (odds ratio = 5.1, 95% confidence interval 1.6-15.8, p = 0.005). CONCLUSIONS: Multiple endoscopic treatments are associated with poorer outcomes and should be limited to achalasia patients who fail surgical therapy.

Laparoscopic and open distal pancreatectomy: a comparison of outcomes.

Laparoscopic (lap) pancreatic surgery has been increasingly reported since its introduction in 1992. A retrospective analysis of consecutive patients undergoing elective lap and open distal pancreatectomy from 2002 to 2007 was performed. Univariate analysis was completed to evaluate perioperative variables. Logistic regression analysis was used to model predictors of postoperative pancreatic fistula. One hundred forty-eight subjects underwent distal pancreatectomy; 98 completed open, 44 lap, and six converted to open. There was no significant difference in the incidence of postoperative morbidity or mortality between the surgical approaches. Decreased operative time (156 vs 200 minutes, P < 0.01), blood loss (157 vs 719 mL, P < 0.01), and length of stay (5.9 vs 8.6 days, P < 0.01) were seen in the lap group. There was no significant difference in the rate of all pancreatic fistula formation (50 vs 46%, P = 0.94) or clinically significant leaks (18 vs 19%, P = 0.97) between techniques. A preoperative biopsy-proven cancer, increasing body mass index, history of pancreatitis, and male gender were significant predictors of having a pancreatic fistula. Lap and open distal pancreatectomy are performed safely at high-volume pancreatic surgery centers. This report provides ongoing support of the feasibility and safety of the lap approach with improved perioperative outcomes and equivalent pancreatic fistula rate.

Prevention of post-operative leak following laparoscopic Heller myotomy.

PURPOSE: Laparoscopic Heller myotomy is the preferred treatment for achalasia. Post-operative leaks cause significant morbidity and impair functional outcome. This study assesses the efficacy of intra-operative leak testing on post-operative leak rate. METHODS: A retrospective analysis of 106 consecutive patients undergoing laparoscopic Heller myotomy by a single surgeon between November 2001 and August 2006 was undertaken. Intra-operative leak testing was performed in all patients. Variables associated with intra-operative mucosotomy were assessed by univariate analysis and logistic regression modeling. RESULTS: Intra-operative mucosotomy occurred in 25% of patients. All mucosotomies were repaired primarily and tested with methylene-blue-stained saline. Dor fundoplication was performed in 74% of the patients. There were no post-operative leaks and patients were started on diet day of surgery. Mean LOS was 1.4(+/-0.7) days. Logistic regression modeling demonstrated that prior myotomy was associated with a statistically significant increase in the rate of mucosotomy (p = 0.033), while previous botox injection (p = 0.193), pneumatic dilation (p = 0.599) or concomitant hiatal hernia (p = 0.874) were not significantly associated with mucosotomy. CONCLUSION: Laparoscopic Heller myotomy for the treatment of achalasia is a safe procedure. Intra-operative leak testing minimizes the risk of post-operative leaks and expedites post-operative management. Prior endoscopic treatment does not impair operative results.

Risk of complications from enterotomy or unplanned bowel resection during elective hernia repair.

HYPOTHESIS: Enterotomy or unplanned bowel resection (EBR) may occur during elective incisional hernia repair (IHR) and significantly affects surgical outcomes and hospital resource use. DESIGN: Retrospective review of patients undergoing IHR between January 1998 and December 2002. SETTING: Sixteen tertiary care Veterans Affairs medical centers. PATIENTS: A total of 1124 elective incisional hernia repairs identified in the National Surgical Quality Improvement Program data set. INTERVENTION: Elective IHR. MAIN OUTCOME MEASURES: Thirty-day postoperative complication rate, return to operating room, length of stay, and operative time. RESULTS: Of the 1124 elective procedures, 74.1% were primary IHR, 13.3% were recurrent prior mesh IHR, and 12.6% were recurrent prior suture. Overall, 7.3% had an EBR. The incidence of EBR was increased in patients with prior repair: 5.3% for primary repair, 5.7% for recurrent prior suture, and 20.3% for prior mesh repair (P < .001). The occurrence of EBR was associated with increased postoperative complications (31.7% vs 9.5%; P < .001), rate of reoperation within 30 days (14.6% vs 3.6%; P < .001), and development of enterocutaneous fistula (7.3% vs 0.7%; P < .001). After adjusting for procedure type, age, and American Society of Anesthesiologists class, EBR was associated with an increase in median operative time (1.7 to 3.5 hours; P < .001) and mean length of stay (4.0 to 6.0 days; P < .001). CONCLUSIONS: Enterotomy or unplanned bowel resection is more likely to complicate recurrent IHR with prior mesh. The occurrence of EBR is associated with increased postoperative complications, return to the operating room, risk of enterocutaneous fistula, length of hospitalization, and operative time.

Variation in mesh placement for ventral hernia repair: an opportunity for process improvement?

BACKGROUND: Incisional hernia repair (IHR) with mesh has been associated with decreased hernia recurrence. We analyzed variation in mesh use for IHR. METHODS: A cohort undergoing IHR from 16 Veterans' Administration (VA) Hospitals was identified. Patient-specific variables were obtained from National Surgical Quality Improvement Program (NSQIP) data. Operative variables were obtained from physician-abstracted operative notes. Univariate and multivariable logistic regression analyses were used to model mesh implantation predictors. RESULTS: A total of 1,123 IHR cases were analyzed; Mesh was implanted in 69.6% (n = 781). Regression models demonstrated repair at a high performing facility was associated with a nearly 4-fold increase in mesh utilization. Other significant predictors include repair of recurrent hernia, chronic steroid use, and multiple fascial defects. CONCLUSIONS: There is variation in the rate of mesh placement for IHR by VA facility, even after accounting for key explanatory variables. Patterns of mesh placement in IHR appear to be based on practice style.

Umbilical herniorrhapy in cirrhosis: improved outcomes with elective repair.

OBJECTIVE: This study was undertaken to examine the effect of cirrhosis on elective and emergent umbilical herniorrhapy outcomes. METHODS: Procedures were identified from the Veterans' Affairs National Surgical Quality Improvement Program at 16 hospitals. Medical records and operative reports were physician abstracted to obtain preoperative and intraoperative variables. RESULTS: Of the 1,421 cases reviewed, 127 (8.9%) had cirrhosis. Cirrhotics were more likely to undergo emergent repair (26.0% vs. 4.8%, p < 0.0001), concomitant bowel resection (8.7% vs. 0.8%, p < 0.0001), return to operating room (7.9% vs. 2.5%, p = 0.0006), and increased postoperative length of stay (4.0 vs. 2.0 days, p = 0.01). Best-fit regression models found cirrhosis was not a significant predictor of postoperative complications. Significant predictors of complications were emergent case (OR 5.4; 95% CI 3.1-9.4), diabetes (OR 2.1; 95% CI 1.2-3.8), congestive heart failure (OR 4.0; 95% CI 1.4-11.4), and chronic obstructive pulmonary disease (OR 2.0; 95% CI 1.1-3.6). Among emergent repairs, cirrhosis (OR 4.4; 95% CI 1.3-14.3) was strongly associated with postoperative complications. CONCLUSION: Elective repair in cirrhotics is associated with similar outcomes as in patients without cirrhosis. Emergent repair in cirrhotics is associated with worse outcomes. Early elective repair may improve the overall outcomes for patients with cirrhosis.

Improvement in gastrointestinal symptoms and quality of life after cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy (LC) is the accepted treatment for symptomatic cholelithiasis but has been criticized as an overused procedure. This study assesses the effectiveness of LC on reduction in gastrointestinal (GI) symptoms and the impact on quality of life (QOL). METHODS: A prospective cohort of subjects evaluated for gallstone disease between August 2001 and July 2004 completed preoperative and postoperative GI gallbladder symptom surveys (GISS) and SF36 QOL surveys. The GISS was developed to quantify the magnitude, severity, and distressfulness of 16 GI symptoms. Surveys were scored and evaluated using paired t tests. RESULTS: Fifty-five subjects were included in the final analysis. The GISS revealed significant improvement in biliary type symptoms but not reflux or irritable bowel symptoms after LC (P > .05). Significant improvement was seen in QOL (P < .01). CONCLUSION: This study supports the utility of LC by showing not only a significant reduction of GI symptoms but also marked improvement in patients' general QOL.

Outcomes of cholecystectomy after endoscopic sphincterotomy for choledocholithiasis.

Laparoscopic cholecystectomy (LC) for treatment of symptomatic common bile duct stones (CBDS) after endoscopic sphincterotomy (ES) is associated with increased conversion and complications compared with other indications. We examined factors associated with conversion and complications of LC after ES. A retrospective study of 32 patients undergoing ES for CBDS followed by cholecystectomy was undertaken. Surgical outcomes for this group were compared with a control population of 499 LCs for all other indications. Factors associated with open cholecystectomy and complications in the ES group were analyzed. Patients undergoing LC preceded by ES had a significantly higher complication (odds ratio [OR] = 7.97; 95% CI, 2.84-22.5) and conversion rate (OR = 3.45; 95% CI, 1.56-7.66) compared with LC for all other indications. Pre-ES serum bilirubin greater than 5 mg/dL was predictive of conversion (positive predictive value = 63%, P < 0.005). Patients with symptomatic CBDS that undergo LC after ES have higher complication and conversion rates than patients undergoing LC without ES. Pre-ES serum bilirubin is useful in identifying patients who may not have a successful laparoscopic approach at cholecystectomy.

Obesity status and use of general surgery resources.

Obesity is a rapidly growing epidemic. This study assesses the impact of obesity on surgeon workload for general surgical services. A retrospective study of patients undergoing cholecystectomy, unilateral mastectomy, and colectomy between January 2000 and December 2003 was undertaken. Obesity was defined as body mass index > or = 30. The proportion of obese patients was compared to the 2002 BRFSS obesity prevalence data for Alabama. Data were adjusted to control for potential confounders. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. A total of 1,385 patients were included in analysis. The prevalence of obesity in the study population was 35.5 per cent compared to the statewide prevalence of 25.2 per cent (OR = 1.73, 95% CI = 1.51, 1.98). These data were stratified by procedure, age, and gender. The cholecystectomy group had a significantly higher proportion of obese for all age groups and female gender. The mastectomy group had a higher proportion of obese in the 45-64 age group. The stratified colectomy group did not reach statistical significance. There was no evidence of referral bias to explain these findings. This study demonstrates there is a greater use of general surgery services, particularly cholecystectomy and mastectomy, in obese patients than predicted by the prevalence of obesity in the population.

Predictors of wound infection in ventral hernia repair.

BACKGROUND: Postoperative wound infection is a significant risk factor for recurrence after ventral hernia repair (VHR). The current study examines patient- and procedure-specific variables associated with wound infection. METHODS: A cohort of subjects undergoing VHR from 13 regional Veterans Health Administration (VHA) sites was identified. Patient-specific risk variables were obtained from National Surgical Quality Improvement Program (NSQIP) data. Operative variables were obtained from physician-abstracted operative notes. Univariate and multivariable logistic regression analysis was used to model predictors of postoperative wound infection. RESULTS: A total of 1505 VHR cases were used for analysis; wound infection occurred in 5% (n = 74). Best-fit logistic regression models demonstrated that steroid use, smoking, prolonged operative time, and use of absorbable mesh, acting as a surrogate marker for a more complex procedure, were significant independent predictors of wound infection. CONCLUSION: Permanent mesh placement was not associated with postoperative wound infection. Smoking was the only modifiable risk factor and preoperative smoking cessation may improve surgical outcomes in VHR.

Variation in Institutional Review processes for a multisite observational study.

BACKGROUND: The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study. METHODS: Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated. RESULTS: Significant differences were found in median time to complete applications by IRB affiliation (P < .01) and median time to approval by changes required to the consent letter (P < .05). CONCLUSIONS: The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.