Is non-operative management warranted in ventral hernia patients with comorbidities? A case-matched, prospective 3 year follow-up, patient-centered study.

BACKGROUND: We hypothesized that long-term quality of life (QoL) is improved among patients with ventral hernias (VHs) and comorbid conditions managed operatively than with non-operative management. METHODS: This was the 3-year follow-up to a prospective observational study of patients with comorbid conditions and VHs. Primary outcome was change in QoL measured utilizing the modified Activities Assessment Scale (AAS), a validated, hernia-specific survey. Outcomes were compared using: (1)paired t-test on matched subset and (2)multivariable linear regression on the overall cohort. RESULTS: In the matched cohort (n = 80; 40/group), the operative group experienced a significantly greater improvement in QoL compared to the non-operative group (28.4 ±â€¯27.1 vs. 11.8 ±â€¯23.8,p = 0.005). The operative group, had 10 (25.0%) reported recurrences while the non-operative group, reported 4/15 (26.7%) recurrences among the 15 (37.5%) patients that underwent repair. On multivariable analysis of the whole cohort (n = 137), operative management was associated with a 19.5 (95% CI7.0-31.9) point greater improvement in QoL compared to non-operative management. CONCLUSIONS: This is the first long term prospective study showing the benefits of operative as opposed to non-operative management of patients with comorbid conditions and VHs.

Impact of Abdominal Wall Hernias and Repair on Patient Quality of Life.

BACKGROUND: The modified Activities Assessment Scale (AAS) is a 13-question abdominal wall quality of life (AW-QOL) survey validated in patients undergoing ventral hernia repair (VHR). No studies have assessed AW-QOL among individuals without abdominal wall pathology. The minimal clinically important difference (MCID) of the modified AAS and its implications for the threshold at which VHR should be offered also remain unknown. Our objectives were to (1) establish the AW-QOL of patients with a clinical abdominal wall hernia versus those with no hernia, (2) determine the MCID of the modified AAS, and (3) identify the baseline quality of life (QOL) score at which patients derive little clinical benefit from VHR. METHODS: Patient-centered outcomes data for all patients presenting to General Surgery and Hernia Clinics October-December 2016 at a single safety-net institution were collected via a prospective, cross-sectional observational study design. Primary outcome was QOL measured using the modified AAS. Secondary outcome was the MCID. RESULTS: Patients with no hernia had modified AAS scores of 81.6 (50.4-94.4), while patients with a clinically apparent hernia had lower modified AAS scores of 31.4 (12.6-58.7) (p < 0.001). The MCID threshold was 7.6 for a "slight" change and 14.9 for "definite" change. Above a modified AAS score of 81, the risk of worsening a patient's QOL by surgery is higher than the chances of improvement. CONCLUSIONS: VHR can improve 1-year postsurgical AW-QOL to levels similar to that of the general population. The MCID of the modified AAS is 7.6 points. Patients with high baseline scores should be counseled about the lack of potential benefit in QOL from elective VHR.

Decreasing Surgical Site Infections after Ventral Hernia Repair: A Quality-Improvement Initiative.

BACKGROUND: Surgical site infections (SSIs) remain prevalent after ventral hernia repair (VHR). In 2013-2014, a safety-net academic hospital initiated a two-pronged quality-improvement (QI) project: (1) Development and implementation of evidence-based guidelines; and (2) creation of a specialized hernia clinic to manage challenging patients and complex ventral hernias. Our objective was to decrease SSI rates after elective VHR. METHODS: The primary outcome was SSI 30 days post-operatively, which was assessed in aggregate and with a stratified analysis based on case complexity using the χ2 test. RESULTS: A total of 399 patients in the pre-QI period and 390 patients in post-QI period (178 patients in general surgery clinics; 212 patients in the specialty hernia clinic) underwent VHR. Patients treated in the post-QI period were less likely to experience an SSI (13.5% vs. 1.5%; p < 0.001). On subgroup analysis of the post-QI clinics, specialty hernia clinic patients had an even lower risk of SSI than those in general surgery clinics (1.4% versus 1.7%). CONCLUSIONS: The QI initiatives of evidence-based guidelines and the specialty hernia clinic were associated with lower SSI rates. Differences in peri-operative management included differences in patient selection and pre-operative preparation and increased use of synthetic mesh and laparoscopy. Future studies must investigate the long-term outcomes of these initiatives.

Predicting delayed discharge in a multimodal Enhanced Recovery Pathway.

BACKGROUND: Despite advances with Enhanced Recovery Pathways(ERP), some patients have unexpected prolonged lengths of stay(LOS). Our goal was to identify the patient and procedural variables associated with delayed discharge despite an established ERP. METHODS: A divisional database was reviewed for minimally invasive colorectal resections with a multimodal ERP(8/1/13-7/31/15). Patients were stratified into ERP success or failure based on length of stay ≥5 days. Logistic regression modeling identified variables predictive of ERP failure. RESULTS: 274 patients were included- 229 successes and 45 failures. Groups were similar in demographics. Failures had higher rates of preoperative anxiety(p = 0.0352), chronic pain(p = 0.0040), prior abdominal surgery(p = 0.0313), and chemoradiation(p = 0.0301). Intraoperatively, failures had higher conversion rates(13.3% vs. 1.7%, p = 0.0002), transfusions(p = 0.0032), and longer operative times(219.8 vs. 183.5min,p = 0.0099). Total costs for failures were higher than successes($22,127 vs. $13,030,p = 0.0182). Variables independently associated with failure were anxiety(OR 2.28, p = 0.0389), chronic pain(OR 10.03, p = 0.0045), and intraoperative conversion(OR 8.02, p = 0.0043). CONCLUSIONS: Identifiable factors are associated with delayed discharge in colorectal surgery. By prospectively preparing for patient factors and changing practice to address procedural factors and ERP adherence, postoperative outcomes could be improved.

Impact of long-acting local anesthesia on clinical and financial outcomes in laparoscopic colorectal surgery.

BACKGROUND: Our objective was to assess clinical and financial outcomes with long-acting liposomal bupicavaine (LB) in laparoscopic colorectal surgery. METHODS: Patients that received local infiltration with LB were strictly matched to a control group, and compared for postoperative pain, opioid use, length of stay (LOS), hospital costs, and complication, readmission, and reoperation rates. RESULTS: A total of 70 patients were evaluated in each cohort. Operative times and conversion rates were similar. LB patients had lower post-anesthesia care unit pain scores (P = .001) and used less opioids through postoperative day 3 (day 0 P < .01; day 1 P = .03; day 2 P = .02; day 3 P < .01). Daily pain scores were comparable. LB had shorter LOS (mean 2.96 vs 3.93 days; P = .003) and trended toward lower readmission, complication, and reoperation rates. Total costs/patient were $746 less with LB, a savings of $52,200 across the cohort. CONCLUSIONS: Using local wound infiltration with LB, opioid use, LOS, and costs were improved after laparoscopic colorectal surgery. The additional medication cost was overshadowed by the overall cost benefits. Incorporating LB into a multimodal pain regiment had a benefit on patient outcomes and health care utilization.

A Prospective Assessment of Clinical and Patient-Reported Outcomes of Initial Non-Operative Management of Ventral Hernias.

BACKGROUND: Little is known about the clinical or patient-reported outcomes with non-operative management of ventral hernias. The aim of this prospective study is to determine the clinical and patient-reported outcomes of patients undergoing initial non-operative treatment of their ventral hernia. STUDY DESIGN: This was a prospective observational study of patients undergoing non-operative management of ventral hernias. Primary outcome was rate of surgical repair of the ventral hernias. Secondary outcomes included rate of emergency repair, elective repair, and emergency room visits. In addition, validated measurement tools for patient satisfaction and cosmetic satisfaction with their abdomen, abdominal pain, and patient function (modified Activities Assessment Scale, AAS) were utilized. RESULTS: Of 128 patients who underwent non-operative management of a ventral hernia, 99(77.3%) patients were followed for a median (interquartile range) of 12.2(10.4-13.5) months. Twenty (20.2%) patients had at least 1 emergency room visit associated with their hernia. One-quarter (n = 2323.2%) underwent ventral hernia repair following enrollment. Twenty (20.2%) underwent elective repair, and 3 (3.0%) underwent emergent repair. Based on the modified AAS survey, patients who were managed non-operatively experienced no change in patient centered outcomes, while patients converted to operative management had improved scores. CONCLUSIONS AND RELEVANCE: While the short-term risk of emergency surgery with non-operative management of ventral hernias is moderate, the chance of an emergency room visit and surgery is high. Patients who undergo non-operative management of their ventral hernias have no change in patient-reported outcomes at one year, while those converted to operative management experience improvement.

How Long Is Long Enough to Identify a Surgical Site Infection?

BACKGROUND: The U.S. Centers for Disease Control requires 90 days after surgery using an implant to diagnose or show the absence of a surgical site infection (SSI). However, many databases only track outcomes up to 30 days. The cost and effort to increase follow-up to 90 days after surgery is high and the benefit is unclear. We hypothesize that the majority of SSIs after ventral hernia repair occur within 30 days of surgery. PATIENTS AND METHODS: All patients who underwent ventral hernia repair (with or without mesh) from 2010-2015 at a single institution were evaluated for evidence of SSI. The duration between surgery and the diagnosis of a post-operative SSI was assessed. Baseline and operative characteristics were compared between patients with an early SSI (within 30 days of surgery) and those with a late SSI (more than 30 days after surgery). RESULTS: Among 1,635 patients who underwent ventral hernia repair, 117 (7.2%) developed an SSI. The median (range) of days between surgery and SSI was 15 days (range, 2-763). There were 20 (17.1%) late SSIs diagnosed; of these, 17 were diagnosed between 31-90 d and three were diagnosed later than 90 days. Patients with a late SSI were more likely to have had a prior ventral hernia repair and have had biologic mesh (p = 0.001). CONCLUSIONS: Whereas the majority of SSIs after ventral hernia repair occurred within the first 30 days, a substantial number of late SSIs occurred. It is worthwhile to follow patients for at least 90 days post-operative in order to capture a more accurate picture of the true rate of SSI.

Is Nonoperative Management Warranted in Ventral Hernia Patients With Comorbidities?: A Case-matched, Prospective, Patient-centered Study.

OBJECTIVE: The aim of this study was to determine patient-centered outcomes of nonoperative treatment of a ventral hernia. SUMMARY OF BACKGROUND DATA: Nonoperative management of ventral hernias (VHs) is often recommended for patients at increased risk of complications; however, the impact of this management strategy on outcome and quality of life (QoL) is unknown. We hypothesize that QoL and function are better among patients with VHs managed operatively. METHODS: Patients with a VH from a single-center hernia clinic were prospectively enrolled between June 2014 and June 2015. Nonoperative management was recommended if smoking, obesity, or poorly controlled diabetes was present. Primary outcomes were patient-centered outcomes, including QoL and function, which were measured using a validated, hernia-specific survey (modified Activities Assessment Scale) before surgeon' consultation and at 6 months. Other outcomes included surgical site infection (SSI) and recurrence. Risk-adjusted outcomes between nonoperative and operative groups were compared using: paired t test on a propensity score-matched subset and multivariable analysis on the overall cohort. RESULTS: A total of 152 patients (nonoperative = 97, operative = 55) were enrolled. In the propensity-matched cohort (n = 90), both groups had similar baseline QoL and function scores, but only repaired patients had improved scores on 6-month follow-up. In the overall cohort, nonoperative management was strongly associated with lower function scores (log odds ratio = -26.5; 95% confidence interval = -35.0 to -18.0). CONCLUSIONS: This is the first prospective study comparing management strategies in VH patients with comorbidities. Elective repair improves hernia-related QoL and function in low- to moderate-risk patients and should be considered in appropriately selected patients.

Transanal Minimally Invasive Surgery: Review of Indications and Outcomes from 75 Consecutive Patients.

BACKGROUND: Transanal minimally invasive surgery (TAMIS) is an advanced local excision platform that helps overcome technical limitations and morbidity associated with other resection methods. Our goal was to review the indications and outcomes of TAMIS in a large series. STUDY DESIGN: A review of a prospective database identified patients who underwent TAMIS from 2010 to 2014. Demographic, perioperative, short-term outcomes, and recurrence data were analyzed. RESULTS: There were 75 patients with 76 lesions analyzed. Mean age was 64.0 years (SD 11.6 years) and mean BMI was 27.4 kg/m(2) (SD 4.7 kg/m(2)). Median American Society of Anesthesiologists (ASA) score was 2 (range 1 to 4). There were 59 benign (77.3%) and 17 malignant (22.7%) lesions: 6 pT0, 6 pT1, 4 pT2, and 1 pT3. Median lesion distance from the anal verge was 10 cm (range 6 to 16 cm). Mean operative time was 76.0 minutes (SD 36.1 minutes). Three patients had intraperitoneal entry; all were closed transanally, but 2 had temporary diverting ileostomies fashioned to ensure healing. Median length of stay was 1 day (range 0 to 6). One patient had a fragmented lesion (1.3%). Five patients had positive margins: 2 in palliative pT2 resections, and 3 in pT1, pT2, and gastrointestinal stromal tumor (GIST) patients. They were managed with radical resection (pT1 and pT2 lesions) and surveillance/medical oncology (GIST). Postoperatively, 3 patients had complications (bleeding, rectal stricture, and recto-vaginal fistula), and all were managed nonoperatively. After median follow-up of 39.5 months (range 10.5 to 65.3 months), 1 pT1 patient with negative margins developed a local recurrence and underwent salvage APR. CONCLUSIONS: Transanal minimally invasive surgery is a viable option for excision of benign or early stage rectal masses, with mid-term oncologic outcomes comparable to those of radical resection. Further, TAMIS minimizes the morbidity and can allow more patients to benefit from the minimally invasive approach.

Review of 500 single incision laparoscopic colorectal surgery cases - Lessons learned.

Single incision laparoscopic surgery (SILS) is a minimally invasive platform with specific benefits over traditional multiport laparoscopic surgery. The safety and feasibility of SILS has been proven, and the applications continue to grow with experience. After 500 cases at a high-volume, single-institution, we were able to standardize instrumentation and operative steps, as well as develop adaptations in technique to help overcome technical and ergonomic challenges. These technical adaptations have allowed the successful application of SILS to technically difficult patient populations, such as pelvic cases, inflammatory bowel disease cases, and high body mass index patients. This review is a frame of reference for the application and wider integration of the single incision laparoscopic platform in colorectal surgery.

Evaluating quality across minimally invasive platforms in colorectal surgery.

INTRODUCTION: There is an increasing emphasis on optimizing and measuring surgical quality. The safety and efficacy of minimally invasive techniques have been proven; however, direct comparison of outcomes across platforms has not been performed. Our goal was to compare operative times and quality across three minimally invasive platforms in colorectal surgery. METHODS: A prospective database was reviewed for elective minimally invasive surgery (MIS) cases from 2008 to 2014. Patients were stratified into multiport laparoscopic, single-incision laparoscopic (SILS) or robotic-assisted laparoscopic approaches (RALS). Demographics, perioperative, and postoperative outcomes were analyzed. Multivariate regression analysis was used to predict the demographic and procedural factors and outcomes associated with each platform. The main outcome measures were operative time and surgical quality by approach. RESULTS: A total of 1055 cases were evaluated-28.4 % LAP, 18.5 % RALS, and 53.1 % SILS. RALS had the most complex patients, pathology, and procedures. The main diagnosis for RALS was rectal cancer (49.5 %), patients predominantly underwent pelvic surgery (72.8 %), had higher rates of neoadjuvant chemoradiation (p < 0.001) and stoma creation (p < 0.001). RALS had the longest operative time and highest complication and readmissions rates (all p < 0.001). Multiport patients were older than SILS and RALS (p = 0.021), had the most intraoperative complications (p < 0.001), conversions (p < 0.001), and had the longest length of stay (p = 0.001). SILS had the shortest operative times (p < 0.001), length of stay (p = 0.001), and lowest rates of complications (p < 0.001), readmissions (p < 0.001), and unplanned reoperation (p = 0.014). All platforms offered high quality (HARM score 0) from overall short LOS, low readmission, and mortality rates. CONCLUSIONS: Multiport, RALS, and SILS each serve a distinct demographic and disease profile and have predictable outcomes. All have risks and benefits, but offer overall high-quality care with a composite of LOS, readmission, and mortality rates. Operative times were directly associated with readmission rates. As all three platforms offer good quality, the choice of which MIS approach to use should be guided by demographics and disease process.

Facilitators and barriers of implementing enhanced recovery in colorectal surgery at a safety net hospital: A provider and patient perspective.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) pathways are known to decrease complications and duration of stay in colorectal surgery patients. However, it is unclear whether an ERAS pathway would be feasible and effective at a safety-net hospital. The aim of this study was to identify local barriers and facilitators before the adoption of an ERAS pathway for patients undergoing colorectal operations at a safety-net hospital. METHODS: Semistructured interviews were conducted to assess the perceived barriers and facilitators before ERAS adoption. Stratified purposive sampling was used. Interviews were audiotaped, transcribed verbatim, and analyzed using content analysis. Analytic and investigator triangulation were used to establish credibility. RESULTS: Interviewees included 8 anesthesiologists, 5 surgeons, 6 nurses, and 18 patients. Facilitators identified across the different medical professions were (1) feasibility and alignment with current practice, (2) standardization of care, (3) smallness of community, (4) good teamwork and communication, and (5) caring for patients. The barriers were (1) difficulty in adapting to change, (2) lack of coordination between different departments, (3) special needs of a highly comorbid and socioeconomically disadvantaged patient population, (4) limited resources, and (5) rotating residents. Facilitators identified by the patients were (1) welcoming a speedy recovery, (2) being well-cared for and satisfied with treatment, (3) adequate social support, (4) welcoming early mobilization, and (5) effective pain management. The barriers were (1) lack of quiet and private space, (2) need for more patient education and counseling, and (3) unforeseen complications. CONCLUSION: Although limited hospital resources are perceived as a barrier to ERAS implementation at a safety-net hospital, there is strong support for such pathways and multiple factors were identified that may facilitate change. Inclusion of patient perspectives is critical to identifying challenges and facilitators to implementing ERAS changes focused on optimizing patient perioperative health and outcomes.

Use of Computed Tomography in Diagnosing Ventral Hernia Recurrence: A Blinded, Prospective, Multispecialty Evaluation.

IMPORTANCE: Physical examination misses up to one-third of ventral hernia recurrences seen on radiologic imaging. However, tests such as computed tomographic (CT) imaging are subject to interpretation and require validation of interobserver reliability. OBJECTIVE: To determine the interobserver reliability of CT scans for detecting a ventral hernia recurrence among surgeons and radiologists. We hypothesized there would be significant disagreement in the diagnosis of a ventral hernia recurrence among different observers. Our secondary aim was to determine reasons for disagreement in the interpretation of CT scans. DESIGN, SETTING, AND PARTICIPANTS: One hundred patients who underwent ventral hernia repair from 2010-2011 at an academic health care center with a postoperative CT scan were randomly selected from a larger cohort. This study was conducted from July 2014 to March 2015. Prospective assessment of the presence or absence of a recurrent ventral hernia on CT scans was compared among 9 blinded reviewers and the radiology report. Five reviewers (consensus group) met to discuss all CT scans with disagreement. The discussion was assessed for keywords and key concepts. The remaining 4 reviewers (validation group) read the consensus group recommendations and reassessed the CT scans. Pre- and post-review κ were calculated; the post-review assessments were compared with clinical examination findings. MAIN OUTCOMES AND MEASURES: Interobserver reliability in determining hernia recurrence radiographically. RESULTS: Of 100 CT scans, there was disagreement among all 9 reviewers and the radiology report on the presence/absence of a ventral hernia in 73 cases (κ = 0.44; 95% CI, 0.35-0.54; P < .001). Following discussion among the consensus group, there remained disagreement in 10 cases (κ = 0.91; 95% CI, 0.83-0.95; P < .001). Among the validation group, the κ value had a slight improvement from 0.21 (95% CI, 0.12-0.33) to 0.34 (95% CI, 0.23-0.46) (P < .001) after reviewing the consensus group proposals. There was disagreement between clinical examination and the consensus group assessment of CT scans on the presence/absence of a ventral hernia in 25 cases. The concepts most frequently discussed were the absence of an accepted definition for a radiographic ventral hernia and differentiating pseudorecurrence from recurrence. CONCLUSIONS AND RELEVANCE: Owing to the high interobserver variability, CT scan was not associated with reliable diagnosing in ventral hernia recurrence. Consensus guidelines and improved communication between surgeon and radiologist may decrease interobserver variability.

SILS v SILS+1: a Case-Matched Comparison for Colorectal Surgery.

BACKGROUND: Single-incision laparoscopic surgery (SILS) is safe and feasible for benign and malignant colorectal diseases. SILS has comparable or improved outcomes compared to multiport laparoscopy but technical limitations when operating in the pelvis. To address these limitations, we developed an innovative SILS+1 approach using a single Pfannenstiel incision for pelvis access with one additional umbilical port. Our goal was to compare outcomes for SILS and SILS+1 in lower abdominal and pelvic colorectal surgery. METHODS: Review of a prospectively maintained database identified patients who underwent an elective reduced port laparoscopic lower abdominal/pelvic colorectal procedure from 2009 to 2014. Cases were stratified by approach: SILS versus SILS+1 then matched 1:2 on age, gender, body mass index (BMI), comorbidity, and procedure. Demographic, perioperative, and postoperative outcome variables were evaluated. The main outcome measures were operative time, conversion rate, length of stay, complication, morbidity, and mortality rates. RESULTS: One hundred thirty-two reduced port AR/LAR patients were evaluated-44 SILS and 88 SILS+1. The groups were similar in age, gender, BMI, and ASA class. The primary diagnosis in both cohorts was diverticulitis (90.9 % SILS, 87.5 % SILS+1), and main procedure performed an anterior rectosigmoidectomy (86.4 % SILS, 88.2 % SILS+1). Significantly more SILS+1 patients had previous abdominal surgery (p = 0.01). The operative time was significantly shorter in SILS+1 (mean 166.6 [SD 48.4] vs. 178.0 [SD 70.0], p = 0.03). The conversion rate to multiport or open surgery was also significantly lower with SILS+1 compared to SILS (1.1 vs. 11.4 %, p = 0.02). Postoperatively, the length of stay across the groups was similar. SILS trended towards higher complication and readmission rates (NS). There were no unplanned reoperations or mortality in either group. CONCLUSIONS: SILS+1 facilitates pelvic and lower abdominal colorectal surgery, with shorter operative times and lower conversion rates. The additional port improved visualization and outcomes without any impact on length of stay, readmission, or complication rates.