Determining the value of the abdominal core health quality collaborative to support regulatory decisions.

PURPOSE: The study objective is to document value created by real-world evidence from the Abdominal Core Health Quality Collaborative (ACHQC) for regulatory decisions. The ACHQC is a national effort that generates data on hernia repair techniques and devices. METHODS: Two retrospective cohort evaluations compared cost and time of ACHQC analyses to traditional postmarket studies. The first analysis was based on 25 reports submitted to the European Medicines Agency of 20 mesh products for post-market surveillance. A second analysis supported label expansion submitted to the Food and Drug Administration, Center for Devices and Radiological Health for a robotic-assisted surgery device to include ventral hernia repair. Estimated costs of counterfactual studies, defined as studies that might have been done if the registry had not been available, were derived from a model described in the literature. Return on investment, percentage of cost savings, and time savings were calculated. RESULTS: 45,010 patients contributed to the two analyses. The cost and time differences between individual 25 ACHQC analyses (41,112 patients) and traditional studies ranged from $1.3 to $2.2 million and from 3 to 4.8 years, both favoring use of the ACHQC. In the second label expansion analysis (3,898 patients), the estimated return on investment ranged from 11 to 461% with time savings of 5.1 years favoring use of the ACHQC. CONCLUSIONS: Compared to traditional postmarket studies, use of ACHQC data can result in cost and time savings when used for appropriate regulatory decisions in light of key assumptions.

Determining the impact of individual ventral hernia repair complications on patient-reported quality of life.

PURPOSE: Ventral hernia repair (VHR) postoperative complications vary in presentation, management, and severity. The aim of this study is to determine the impact of individual postoperative complications on long-term quality of life (QoL) after VHR. METHODS: Data from the Abdominal Core Health Quality Collaborative were analyzed retrospectively. Propensity score matching compared 1-year postoperative Hernia-Related Quality of Life Survey (HerQLes) summary scores between non-wound events (NWE), surgical site infection (SSI), and surgical site occurrence requiring procedural intervention (SSOPI) versus No-Complications. RESULTS: 2796 patients who underwent VHR between 2013 and 2022 met the study criteria. Patients with SSI and SSOPI had lower QoL vs No-Complications (median (Interquartile range): 71 (40-92) vs 83 (52-94), P = 0.02; 68 (40-90) vs 78 (55-95), P = 0.008). NWE vs no-complications HerQLes score differences were similar (83 (53-92) vs 83 (60-93), P = 0.19). CONCLUSION: Wound events seem to have larger impact on patients' long-term QoL compared to NWE. Continued and aggressive efforts including preoperative optimization, technical points, and appropriate use of minimally invasive techniques can continue to reduce impactful wound events.

Posterior mesh inguinal hernia repairs: a propensity score matched analysis of laparoscopic and robotic versus open approaches.

PURPOSE: International guidelines suggest the use of lapro-endoscopic technique for primary unilateral inguinal hernia (IHR) because of lower postoperative pain and reduction in chronic pain. It is unclear if the primary benefit is due to the minimally invasive approach, the posterior mesh position or both. Further research evaluating posterior mesh placement using open preperitoneal techniques is recommended. A potential benefit of open preperitoneal repair is the avoidance of general anesthesia, as these repairs can be performed under local anesthesia. This study compares clinical and patient-reported outcomes after unilateral laparo-endoscopic, robotic, and open posterior mesh IHRs. METHODS: We performed a propensity score matched analysis of patients undergoing IHR between 2012 and 2021 in the Abdominal Core Health Quality Collaborative registry. 10,409 patients underwent a unilateral IHR via a posterior approach. Hernia repairs were performed via minimally invasive surgery (MIS) which includes laparoscopic and robotic transabdominal preperitoneal (TAPP), laparoscopic totally extraperitoneal (TEP), or open transrectus preperitoneal/open preperitoneal (TREPP/OPP) approaches. Propensity score matching (PSM) utilizing nearest neighbor matching accounted for differences in baseline characteristics and possible confounding variables between groups. We matched 816 patients in the MIS cohort with 816 patients in the TREPP/OPP group. Outcomes included patient reported quality of life, hernia recurrence, and postoperative opioid use. RESULTS: Improvement was seen after TREPP/OPP as compared to MIS IHR in EuraHS at 30 days (Median(IQR) 7.0 (2.0-16.64) vs 10 (2.0-24.0); OR 0.69 [0.55-0.85]; p = 0.001) and 6 months (1.0 (0.0-4.0) vs 2.0 (0.0-4.0); OR 0.63 [0.46-85]; p = 0.002), patient-reported opioid use at 30-day follow-up (18% vs 45% OR 0.26 [0.19-0.35]; p < 0.001), and rates of surgical site occurrences (0.8% vs 4.9% OR 0.16 [0.06-0.35]; p < 0.001). There were no differences in EuraHS scores and recurrences at 1 year. CONCLUSIONS: This study demonstrates a potential benefit of open posterior mesh placement over MIS repair in short-term quality of life and seroma formation with equivalent rates of hernia recurrence. Further study is needed to better understand these differences and determine the reproducibility of these findings outside of high-volume specialty centers.

Ventral hernia repair: an increasing burden affecting abdominal core health.

PURPOSE: To estimate the annual volume and cost of ventral hernia repair (VHR) performed in the United States. METHODS: A retrospective cohort study was performed using the National Inpatient Sample (NIS) and the Nationwide Ambulatory Surgery Sample (NASS) for 2016-2019. Patients over the age of 18 who underwent open (OVHR) or minimally invasive ventral hernia repair (MISVHR) were identified. NIS procedural costs were estimated using cost-to-charge ratios; NASS costs were estimated using the NIS cost-to-charge ratios stratified by payer status. Costs were adjusted for inflation to 2021 dollars using US Bureau of Labor Statistics Consumer Price Index. RESULTS: On average 610,998 VHRs were performed per year. Most were outpatient (67.3% per year), and open (70.7%). MIS procedures increased from 25.8% to 32.8% of all VHRs. Inpatient OVHR had significantly higher associated cost than MISVHR [$35,511 (34,100-36,921) vs. $21,165 (19,664-22,665 in 2019]. Outpatient MISVHR was more expensive than OVHR [$11,558 (11,174-11,942 MIS vs. $6807 (6620-6994) OVHR in 2019]. The estimated cost of an inpatient MISVHR remained similar between 2016 and 2019, from $20,076 (13,374-20,777) to $21,165 (19,664-22,665) and increased slightly from $9975 (9639-10,312) to $11,558 (11,174-11,942) in the outpatient setting. The estimated cost of an inpatient OVHR increased from $31,383 (30,338-32,428) to $35,511 (34,100-36,921), while outpatient costs increased from $6018 (5860-6175) to $6807 (6620-6994). VHR costs decreased slightly over the study period to a mean cost of $9.7 billion dollars in 2019. CONCLUSION: Compared to 2006 national data, VHRs in the United States have almost doubled to 611,000 per year with an estimated annual cost of $9.7 billion. A 1% decrease in VHR achieved through recurrence reduction or hernia prophylaxis could save the US healthcare system at least $139.9 million annually.

Stopping prehospital chlorhexidine skin wash does not increase wound morbidity after incisional hernia repair: results of a 4-year quality improvement initiative.

BACKGROUND: Prehospital chlorhexidine gluconate (CHG) skin washes are used to prevent wound complications, but little evidence supports this practice in hernia surgery. A propensity-matched retrospective review published by our group in 2016 found that prehospital CHG was associated with an increased risk of surgical site occurrences (SSO) and surgical site infections (SSI) after ventral hernia repair. Prehospital CHG was, therefore, abandoned by three of five surgeons at the Cleveland Clinic Foundation (CCF) by April 2017. We aimed to determine if discontinuation of prehospital CHG affected wound morbidity rates after incisional hernia repair. METHODS: The Abdominal Core Health Quality Collaborative was queried for all patients who underwent open, clean incisional hernia repairs with 30-day follow-up from 2014 to 2019. Using an interrupted time series (ITS) analysis model adjusted for group and mean propensity score, wound morbidity before and after April 1, 2017 (start of Q2) was compared between three groups: CCF surgeons who abandoned prehospital CHG (Group 1), CCF surgeons who continued using prehospital CHG (Group 2), and non-CCF surgeons using prehospital CHG (Group 3). Outcomes included rates of SSOs, SSIs, and surgical site occurrences requiring procedural intervention (SSOPI) at 30 days. RESULTS: In total, 4276 patients were included in the analysis (Group 1: 339 before Q2 vs 673 after Q2; Group 2: 211 before Q2 vs 175 after Q2; Group 3: 1312 before Q2 vs 1566 after Q2). Rates of SSO, SSIs, and SSOPIs at 30 days were similar across all three groups before and after prehospital CHG discontinuation. CONCLUSION: Stopping prehospital CHG wash did not result in increased wound morbidity after open, clean, incisional hernia repair. We have abandoned CHG use in this context.

Acceptability and barriers to adopting physical therapy and rehabilitation as standard of care in hernia disease: a prospective national survey of providers and preliminary data.

PURPOSE: Physical therapy (PT) and rehabilitation are widely utilized in a variety of disease processes to improve function, return to activities of daily living (ADLs), and promote overall recovery. However, hernia repair has struggled to adopt this practice despite operations occurring in one of the most dynamic parts of the body - the abdominal core. This study sought to understand perspectives and perceived barriers regarding the incorporation of PT and rehabilitation in hernia care. METHODS: A standardized rehabilitation protocol was developed by the Abdominal Core Health Quality Collaborative (ACHQC), a national quality improvement initiative specific to hernia disease, and launched in 2019. Empiric data from the ACHQC was then obtained to describe preliminary utilization. A prospective electronic survey was then deployed to all surgeons participating in the ACHQC to aid in interpreting the identified trends. The survey included questions regarding the current use of PT in their practice, as well as further opinions on the functionality, benefit, and barriers to its use. RESULTS: We identified 1,544 patients who were listed as receiving some form of postoperative rehabilitation, of which 992 (64.2%) had a primary diagnosis of ventral hernia and 552 (35.8%) had an inguinal hernia. Among patients who had a ventral hernia, 863 (87.0%) received self-directed rehabilitation exercises compared to 488 (88.4%) of inguinal hernia patients. The subsequent survey exploring these trends was completed by 46 ACHQC surgeons (10.2%). More than half (52%) reported using PT for hernia patients, primarily in abdominal wall reconstruction cases (92%). Of those who did not report using PT, 50% cited unknown clinical benefit and another 27% cited unknown PT resources. PT utilization was typically concentrated to the postoperative period (58%), while 42% reported also using it preoperatively. Despite 72% of respondents citing a perceived benefit of PT in hernia patients, overall use of PT was primarily reported as 'occasional' by 42%, with another 27% reporting 'rarely.' Perceived benefits of PT included increased core strength, stability, mobility, patient satisfaction, education, independence, earlier return to work and ADLs, overall improved recovery, and decreased risk of postoperative issues. Reported barriers to implementing PT in practice or adapting the ACHQC Rehabilitation Protocol included lack of education, lack of evidence of clinical benefit, and difficulties operationalizing the protocol. CONCLUSION: A national survey of hernia surgeons demonstrated willingness to adopt PT and rehabilitation protocols in their clinical practices and noted a high perceived benefit to patients. However, lack of education and evidence regarding the protocol may represent important barriers to overcome in widely disseminating these resources to patients. These gaps can be addressed through dedicated educational venues and additional studies establishing PT and rehabilitation as critical future adjuncts for the recovery of hernia repair patients.

A systematic review of outcome reporting in incisional hernia surgery.

BACKGROUND: The incidence of incisional hernia is up to 20 per cent after abdominal surgery. The management of patients with incisional hernia can be complex with an array of techniques and meshes available. Ensuring consistency in reporting outcomes across studies on incisional hernia is important and will enable appropriate interpretation, comparison and data synthesis across a range of clinical and operative treatment strategies. METHODS: Literature searches were performed in MEDLINE and EMBASE (from 1 January 2010 to 31 December 2019) and the Cochrane Central Register of Controlled Trials. All studies documenting clinical and patient-reported outcomes for incisional hernia were included. RESULTS: In total, 1340 studies were screened, of which 92 were included, reporting outcomes on 12 292 patients undergoing incisional hernia repair. Eight broad-based outcome domains were identified, including patient and clinical demographics, hernia-related symptoms, hernia morphology, recurrent incisional hernia, operative variables, postoperative variables, follow-up and patient-reported outcomes. Clinical outcomes such as hernia recurrence rates were reported in 80 studies (87 per cent). A total of nine different definitions for detecting hernia recurrence were identified. Patient-reported outcomes were reported in 31 studies (34 per cent), with 18 different assessment measures used. CONCLUSIONS: This review demonstrates the significant heterogeneity in outcome reporting in incisional hernia studies, with significant variation in outcome assessment and definitions. This is coupled with significant under-reporting of patient-reported outcomes.

Hernia recurrence inventory: inguinal hernia recurrence can be accurately assessed using patient-reported outcomes.

PURPOSE: Relying solely on in-person encounters to assess long-term outcomes of hernia repair leads to substantial loss of information and patients lost-to-follow-up, hindering research and quality improvement initiatives. We aimed to determine if inguinal hernia recurrences could be assessed using the Ventral Hernia Recurrence Inventory (VHRI), a previously existing patient-reported outcome (PRO) tool that can be administered through the telephone and has already been validated for diagnosing ventral hernia recurrence. METHODS: A prospective, multicentric comparative study was conducted. Adult patients from two centers (United States and Brazil) at least 1 year after open or minimally invasive inguinal hernia repair were asked to answer the questions of the VHRI in relation to their prior repair. A physical exam was then performed by a blinded surgeon. Testing characteristics and diagnostic performance of the PRO were calculated. Patients with suspected recurrences were preferentially recruited. RESULTS: 128 patients were enrolled after 175 repairs. All patients answered the VHRI and were further examined, where a recurrence was present in 32% of the repairs. Self-reported bulge and patient perception of a recurrence were highly sensitive (84-94%) and specific (93-94%) for the diagnosis of an inguinal hernia recurrence. Test performance was similar in the American and Brazilian populations despite several baseline differences in demographic and clinical characteristics. CONCLUSION: The VHRI can be used to assess long-term inguinal hernia recurrence and should be reestablished as the Hernia Recurrence Inventory (HRI). Its implementation in registries, quality improvement efforts, and research could contribute to improving long-term follow-up rates in hernia patients.

Use of real-world registry data: a hernia mesh example.

PURPOSE: Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices. METHODS: Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types. RESULTS: Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results. CONCLUSIONS: High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.

Early repair of ventral incisional hernia may improve quality of life after surgery for abdominal malignancy: a prospective observational cohort study.

PURPOSE: Recent work has shown that over 40% of patients undergoing surgery for abdominal malignancy develop ventral incisional hernias (VIH) within 2 years. We hypothesized that early repair of VIH for cancer survivors could improve long-term quality of life (QoL). METHODS: All patients presenting with a history of surgery for abdominal malignancy and a VIH were prospectively enrolled. QoL was assessed at baseline and 3-, 6-, 12-, 18-, and 24-month follow-up using abdominal wall-specific (HerQLes) and cancer-specific (FACT-G) instruments. At the study's conclusion, patients were divided into 2 groups-those that underwent VIH repair during the study's course (Repair Group) and those that did not (Control Group). Categorical variables were analyzed using Pearson's Chi-square and continuous variables with Wilcoxon rank sum test. RESULTS: Eighty-four patients were enrolled. Overall, 46 patients (55%) underwent VIH repair, with 36 repairs (78%) occurring within 3 months of initial evaluation. Sixty-six (79%) had complete 1-year follow-up data, and 30 (36%) had 2-year data, with a median follow-up duration of 15.6 months. At baseline, both groups were similar with respect to demographics, cancer stage, and HerQLes/FACT-G scores. Compared to the Controls, the Repair Group showed greater improvements over baseline HerQLes Summary Scores at the 3-, 6-, 12-, and 18-month time points (median increase, 37 vs. 26 points), and in FACT-G total scores at the 3-, 6-, and 12-month time points (median increase, 6 vs. 4 points). CONCLUSIONS: Repair of VIH after surgery for abdominal malignancy may improve abdominal wall-specific and cancer-specific QoL, making post-resection abdominal wall reconstruction an important aspect of cancer survivorship.

A call for standardization of wound events reporting following ventral hernia repair.

INTRODUCTION: Postoperative wound events following ventral hernia repair are an important outcome measure. While efforts have been made by hernia surgeons to identify and address risk factors for postoperative wound events following VHR, the definition of these events lacks standardization. Therefore, the purpose of our study was to detail the variability of wound event definitions in recent ventral hernia literature and to propose standardized definitions for postoperative wound events following VHR. METHODS: The top 50 cited ventral hernia, peer-reviewed publications from 1995 through 2015 were identified using the search engine Google Scholar. The definition of wound event used and the incidence of postoperative wound events was recorded for each article. The number of articles that used a standardized definition for surgical site infection (SSI), surgical site occurrence (SSO), or surgical site occurrence requiring procedural intervention (SSOPI) was also identified. RESULTS: Of the 50 papers evaluated, only nine (18%) used a standardized definition for SSI, SSO, or SSOPI. The papers that used standardized definitions had a smaller variability in the incidence of wound events when compared to one another and their reported rates were more consistent with recently published ventral hernia repair literature. CONCLUSION: Postoperative wound events following VHR are intimately associated with patient quality of life and long-term hernia repair durability. Standardization of the definition of postoperative wound events to include SSI, SSO, and SSOPI following VHR will improve the ability of hernia surgeons to make evidence-based decisions regarding the management of ventral hernias.

Frequency of endoscopic surveillance for Barrett's esophagus is influenced by health insurance status: results from a population-based analysis.

Factors that influence the frequency of surveillance endoscopy for nondysplastic Barrett's esophagus are not well understood. The objective of this study is to assess factors which influence the frequency of endoscopic surveillance for Barrett's esophagus, including health insurance/third-party payer status. Cases of nondysplastic Barrett's esophagus undergoing esophagogastroduodenoscopy with biopsy were identified using longitudinal data from the Healthcare Utilization Project database in 2005-2006 and followed through 2011. The threshold for appropriate surveillance utilization was defined as two to four surveillance esophagogastroduodenoscopies over a standardized 5-year period. Patients' insurance status was designated as either Medicare, Medicaid, private, or noninsured. 36,676 cases of nondysplastic Barrett's esophagus were identified. Among these, 4,632 patients (12.6%) underwent between two and four surveillance esophagogastroduodenoscopies in 5 years of follow-up versus 31,975 patients (87.3%) who underwent fewer than two esophagogastroduodenoscopies during follow-up. Multivariate analysis found that Barrett's patients insured through Medicaid (OR 1.273; 95% CI = 1.065-1.522) or without insurance (OR = 2.453; 95% CI = 1.67-3.603) were at increased likelihood of being under-surveilled. This study identified a difference in frequency of surveillance esophagogastroduodenoscopy for Barrett's esophagus by payer status. Patients without health insurance and those whose primary insurance was Medicaid were at increased odds for under-surveillance. These data suggest that a more robust system for tracking and ensuring longitudinal follow-up of patients with Barrett's esophagus, with attention to the uninsured and underinsured population, may be needed to ensure optimal surveillance.

Is there an association between surgeon hat type and 30-day wound events following ventral hernia repair?

INTRODUCTION: While several patient and operative variables have been shown to be associated with an increased risk of postoperative wound events, the association between surgical hat type worn by surgeons and postoperative wound events remains controversial. The purpose of this study is to investigate the association between type of surgical hat worn by surgeons and the incidence of postoperative wound events following ventral hernia repair using the Americas Hernia Society Quality Collaborative database. METHODS: All surgeons who input at least ten patients with 30-day follow-up into the AHSQC were identified. These surgeons were sent a survey asking them to identify the type of surgical hat they wear in the operating room. The association of the type of surgical hat worn, patient variables, and operative factors with 30-day wound events was investigated using multivariate logistic regression. RESULTS: A total of 68 surgeons responded to the survey, resulting in 6210 cases available for analysis. The type of surgical hat worn by surgeons was not found to be associated with an increased risk of 30-day surgical site infections or surgical site occurrences requiring procedural intervention. CONCLUSION: Our study is the first study to directly compare the association of surgical hat type with postoperative wound events. There is no association between the type of surgical hat worn and the incidence of postoperative wound events following ventral hernia repair. Our findings suggest that surgical hate type may be chosen at the discretion of operating room personnel without fear of detriment to their patients.

Evaluation of long-term surgical site occurrences in ventral hernia repair: implications of preoperative site independent MRSA infection.

PURPOSE: Previous work demonstrated that prior MRSA infection [MRSA(+)] is associated with 30-day surgical site infection (SSI) following ventral hernia repair (VHR). We aimed to determine the impact of MRSA(+) on long-term wound outcomes after VHR. PARTICIPANTS: A retrospective cohort study was performed at a tertiary center between July 11, 2005, and May 18, 2012, of patients undergoing elective VHR with class I wounds. Patients with documented preoperative MRSA infection at any site (urinary, bloodstream, SSI, etc.) were considered MRSA(+). Primary outcome was 2-year surgical site occurrence (SSO), defined as SSI, cellulitis, necrosis, nonhealing wound, seroma, hematoma, dehiscence, or fistula. SSOs were subdivided into those that required procedural intervention (SSOPI) and those that did not. RESULTS: Among 632 patients, 46 % were female with average age 53 ± 13 years. There were 368 SSOs in 193 patients (31 %); an SSOPI occurred in 9.8 % (n = 62). The most common SSOs were cellulitis (91/632), seroma (91/632), and serous drainage (58/632). The rate of 2-year SSO was higher with MRSA(+) compared to those without (46 vs. 29 %, p = 0.023), attributed to increased soft tissue necrosis, purulent drainage, serous drainage, cellulitis, and fistula. In multivariable analysis, MRSA(+) was not associated with 2-year SSO (HR 1.5, 95 % CI 0.91-2.55, p = 0.113); factors associated with SSO included obesity, immunosuppression, mesh repair, and operative times. CONCLUSIONS: This study is the first to evaluate long-term SSOs and SSOPIs after VHR, highlighting the importance of long-term follow-up. Though not independently associated with SSOs, MRSA(+) may be a marker of hernia complexity.

Design and implementation of the Americas Hernia Society Quality Collaborative (AHSQC): improving value in hernia care.

PURPOSE: Wide variation in care and costs exists regarding the management of abdominal wall hernias, with unproven benefit for many therapies. This work establishes a specialty society-based solution to improve the quality and value of care delivered to hernia patients during routine clinical management on a national scale. METHODS: The Americas Hernia Society Quality Task Force was charged by the Americas Hernia Society leadership to develop an initiative that utilizes the concepts of continuous quality improvement (CQI). A disease-based registry was created to collect information for CQI incorporating real-time outcome reporting, patient reported outcomes, stakeholder engagement, and collaborative learning methods to form a comprehensive quality improvement effort. RESULTS: The Americas Hernia Society Quality Collaborative (AHSQC) was formed with the mission to provide health care professionals real-time information for maximizing value in hernia care. The initial disease areas selected for CQI were incisional and parastomal hernias with ten priorities encompassing the spectrum of care. A prospective registry was created with real-time analytic feedback to surgeons. A data assurance process was implemented to ensure maximal data quality and completeness. Four collaborative meetings per year were established to meet the goals of the AHSQC. As of the fourth quarter 2014, the AHSQC includes nearly 2377 patients at 38 institutions with 82 participating surgeons. CONCLUSIONS: The AHSQC has been established as a quality improvement initiative utilizing concepts of CQI. This ongoing effort will continually refine its scope and goals based on stakeholder input to improve care delivered to hernia patients.

Case report: patient portal versus telephone recruitment for a surgical research study.

BACKGROUND: Patient portal adoption has rapidly increased over the last decade. Most patient portal research has been done in primary care or medical specialties, and few studies have examined their use in surgical patients or for recruiting research subjects. No known studies have compared portal messaging with other approaches of recruitment. OBJECTIVES: This case report describes our experience with patient portal versus telephone recruitment for a study involving long-term follow up of surgical patients. METHODS: Participants were recruited for a study of recurrence after ventral hernia repair through telephone calls and patient portal messaging based on registration status with the portal. Potential subjects who did not have a portal account or whose portal messages were returned after 5 days were called. The proportion of participants enrolled with each method was determined and demographics of eligible patients, portal users, and participants were compared. RESULTS: 1359 patients were eligible for the hernia study, and enrollment was 35% (n=465). Most participants were recruited by telephone (84%, n=391); 16% (n=74) were recruited through portal messaging. Forty-four percent of eligible participants had a registered portal account, and 14% of users responded to the recruitment message. Portal users were younger than non-users (55 vs. 58 years, p<0.001); participants recruited through the portal versus telephone were also younger (54 vs. 59 years, p=0.001). Differences in the sex and racial distributions between users and non-users and between portal and telephone recruits were not significant. CONCLUSIONS: Portal versus telephone recruitment for a surgical research study demonstrated modest portal recruitment rates and similar demographics between recruitment methods. Published studies of portal-only recruitment in primary care or medical-specialty patient populations have demonstrated higher enrollment rates, but this case study demonstrates that portal recruitment for research studies in the surgical population is feasible, and it offers convenience to patients and researchers.

Epidemiology and cost of ventral hernia repair: making the case for hernia research.

PURPOSE: Ventral hernia repair (VHR) lacks standardization of care and exhibits variation in delivery. Complications of VHR, notably recurrence and infection, increase costs. Efforts at obtaining federal funding for VHR research are frequently unsuccessful, in part due to misperceptions that VHR is not a clinical challenge and has minimal impact on healthcare resources. We analyzed national trends for VHR performance and associated costs to demonstrate potential savings resulting from an improvement in outcomes. METHODS: Inpatient non-federal discharges for VHR were identified from the 2001-2006 Healthcare Cost and Utilization Project, supplemented by the Center for Disease Control 2006 National Survey of Ambulatory Surgery for outpatient estimates. The total number of VHRs performed in the US was estimated along with associated costs. Costs were standardized to 2010 US dollars using the Consumer Price Index and reported as mean with 95% confidence intervals (95% CI). RESULTS: The number of inpatient VHRs increased from 126,548 in 2001 to 154,278 in 2006. Including 193,543 outpatient operations, an estimated 348,000 VHRs were performed for 2006. Inpatient costs consistently rose with 2006 costs estimated at US $15,899 (95% CI $15,394-$16,404) per operation. Estimated cost for outpatient VHR was US $3,873 (95% CI $2,788-$4,958). The total cost of VHR for 2006 was US $3.2 billion. CONCLUSIONS: VHRs continue to rise in incidence and cost. By reducing recurrence rate alone, a cost saving of US $32 million dollars for each 1% reduction in operations would result. Further research is necessary for improved understanding of ventral hernia etiology and treatment and is critical to cost effective healthcare.

Facilitating gastrotomy closure during natural-orifice transluminal endoscopic surgery using tissue anchors.

BACKGROUND AND STUDY AIMS: Reliable and secure closure of the gastrotomy after natural-orifice transluminal endoscopic surgery (NOTES) remains a critical step for widespread acceptance and use of this mode of surgery. We describe a novel method for gastrotomy closure using endoscopic tissue anchors. METHODS: A standard upper endoscopy and wire placement as used for percutaneous endoscopic gastrostomy placement was performed in five pigs. Prior to gastrotomy, four tissue anchors were placed in four quadrants (1 cm away from the wire). A 12-mm gastrotomy was created endoscopically using a combination of needle-knife and balloon dilation. After transgastric peritoneoscopy, the sutures were approximated using a device knotting element. One additional pair of sutures was placed after evaluation of the gastric closure. The animals underwent in vivo contrast fluoroscopy, methylene blue instillation, and bursting pressure studies for assessment of the closure site. RESULTS: All animals studied showed complete sealing of the gastrotomy site without evidence of leak on fluoroscopic imaging or at final postmortem intragastric methylene blue instillation. Improved insufflation ability following gastrotomy was also noted using this technique, which enhanced overall visualization during the closure. CONCLUSION: Positioning tissue anchors prior to creating a NOTES gastrotomy was a feasible and reliable method to perform gastric closure. Follow-up survival studies will be warranted to support these preliminary findings.

Endoscopic full-thickness resection of gastric tumors using a novel grasp-and-snare technique: feasibility in ex vivo and in vivo porcine models.

BACKGROUND AND STUDY AIMS: Endoscopic full-thickness resection (EFTR) is a less-invasive method of en bloc removal of gastrointestinal tract tumors. The aim of this study was to evaluate the feasibility of a grasp-and-snare EFTR technique using a novel tissue-lifting device that provides more secure tissue anchoring and manipulation. METHODS: EFTR of normal gastric tissue and model stomach tumors was performed using a double-channel therapeutic endoscope with a prototype tissue-lifting device through one channel and a prototype hexagonal snare through the other. The lifting device was advanced through the open snare and anchored to the gastric wall immediately adjacent the model tumor. The tissue-lifting device was then partially retracted into the endoscope, causing the target tissue, including tumor, to evert into the gastric lumen. The open snare was then placed distal to the tumor around uninvolved gastric tissue. Resection was performed with a blended electrosurgical current through the snare. In the live pigs, EFTR was followed by laparotomy to asses for complications. RESULTS: 24 EFTRs were performed -- 14 in explanted stomachs and 10 in live pigs. In total, 23/24 resections resulted in full-thickness gastric defects. Resection specimens measured up to 5.0 cm when stretched and pinned on a histology stage. Gross margins were negative in 17/20 model tumor resections. Two resections were complicated by gastric mural bleeding. There was no evidence of adjacent organ injury. CONCLUSIONS: EFTR of gastric tumors using the grasp-and-snare technique is feasible in pigs. This technique is advantageous in that eversion of the gastric wall avoids injury to external organs, continuous luminal insufflation is not required, and the involved techniques are familiar to endoscopists. Additional research is necessary to further evaluate safety and reliable closure.