Prolonged operative duration is associated with complications: a systematic review and meta-analysis.

BACKGROUND: The aim of this study was to systematically synthesize the large volume of literature reporting on the association between operative duration and complications across various surgical specialties and procedure types. METHODS: An electronic search of PubMed, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews from January 2005 to January 2015 was conducted. Sixty-six observational studies met the inclusion criteria. RESULTS: Pooled analyses showed that the likelihood of complications increased significantly with prolonged operative duration, approximately doubling with operative time thresholds exceeding 2 or more hours. Meta-analyses also demonstrated a 14% increase in the likelihood of complications for every 30 min of additional operating time. CONCLUSIONS: Prolonged operative time is associated with an increase in the risk of complications. Given the adverse consequences of complications, decreased operative times should be a universal goal for surgeons, hospitals, and policy-makers. Future study is recommended on the evaluation of interventions targeted to reducing operating time.

Economic considerations for mid-urethral sling procedures among patients with stress urinary incontinence.

OVERVIEW: Stress urinary incontinence (SUI) is associated with a hefty economic burden. Retropubic and transobturator vaginal slings have become common surgical options for women with SUI. This study examines the costs of transobturator slings for SUI surgeries. METHODS: A model was created to estimate the budget impact to hospitals of transobturator sling surgery in women with SUI. Current practice using transobturator slings including the MonarcTM Subfascial Hammock, Obtryx® Transobturator Mid-Urethral Sling System, Aris® Transobturator Sling System, Align® TO Trans-Obturator Urethral Support System, GYNECARE TVTTM Obturator System Tension-free Support for Incontinence and GYNECARE TVT ABBREVOTM Continence System were modeled. Four surgical complications were considered: re-operation due to failure, revision or removal of sling, urologic complications including urinary obstruction and urinary tract infection, and pelvic complications. This model calculates the average 1-year cost per patient with the use of each sling product and estimates the total budget for sling urinary incontinence surgery associated with each product based on these calculations. RESULTS: Average incremental cost over 1 year ranged from $2,601 (GYNECARE TVTTM Obturator) to $3,132 (Desara®) per patient. In a hypothetical population of 100 patients, a 10% shift from the most to the least expensive option was associated with a 2% decrease in hospital expenditures. With the current market share for transobturator sling products, the expected expenditure is around $285,533 for a surgical population of 100 patients. Sling costs account for approximately $105,526 (37%) of this cost, with complications comprising the remaining majority. CONCLUSION: This study represents the first comparative assessment of the costs of different sling options for stress urinary incontinence surgeries. GYNECARE TVT ABBREVOTM and GYNECARE TVTTM Obturator products represent a sound clinical and economic choice for hospitals. Moreover, the reduction in expenditures is obtained at the benefit of patients, who experience fewer complications and avoid complication-related procedures.

Clinical and economic impact of adhesiolysis during repeat cesarean delivery.

OBJECTIVE: To estimate adhesiolysis rates at cesarean delivery (CD) and to estimate costs and clinical implications of performing adhesiolysis at repeat CD. DESIGN: Retrospective cohort using secondary data. SETTING: Over 500 acute care hospitals in the USA. POPULATION: Women ≥15 years old with a medical claim for CD between 1 January 2007 and 31 December 2008 who were treated in a hospital that contributed data to the Premier Perspective™ database. METHODS: Using data from hospital discharge records, rates of adhesiolysis at the time of CD were calculated. Among patients with repeat CD, a propensity score was used to create matched cohorts with and without adhesiolysis. Unadjusted rates and means were compared between these cohorts. MAIN OUTCOME MEASURES: Cost, length of stay and selected clinical complications between repeat CD patients with and without adhesiolysis. RESULTS: Adhesiolysis was performed in 0.5% of primary and 6.1% of repeat CD patients. Using propensity scores, 10 261 women who experienced repeat CD with adhesiolysis were matched to 10 261 control women. Hospital cost ($5739 vs. $5448), length of stay (2.97 vs. 2.88 days) and operative time (84.0 vs. 74.2 min) were significantly greater in the adhesiolysis than in the non-adhesiolysis group (p < 0.01 for all comparisons), as was the overall complication rate (6.3 vs. 3.5%). CONCLUSIONS: Adhesiolysis rates were higher in repeat compared with primary CD. Among repeat CD patients, costs and complications were higher in the adhesiolysis group. Reducing adhesion formation after primary CD could reduce cost and complications at the time of repeat CD.

A real-world comparative assessment of complications following various mid-urethral sling procedures for the treatment of stress urinary incontinence.

Stress urinary incontinence affects a significant proportion of the adult female population in the United States with prevalence increasing with growing age. Mid-urethral slings are among surgical options offering important improvement in the condition. The aim of this study was to evaluate clinical outcomes of different mid-urethral sling products with respect to postsurgery complications. This retrospective study utilized data from the Premier Perspective Database for mid-urethral sling procedures between 2005 and 2009. Patients were grouped into retropubic or transobturator cohorts, and these cohorts were further divided by the sling utilized during the procedure. Surgical outcomes and 12-month complication rates were assessed. In general, there were fewer complications noted for transobturator procedures than for retropubic procedures. In the retropubic category, Gynecare TVT had significantly lower rates of urinary obstruction/retention than other retropubic procedures. In the transobturator category, lower rates of overall pelvic complications as well as urologic complications, including urgency incontinence and urinary tract infections, were observed in the Gynecare TVTO subgroup than other transobturator procedures. Results of this study confirm the low overall rate of complications for midurethral sling procedures while at the same time suggesting that product choice may also have an impact on complication rates.

A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence.

PURPOSE: Mid urethral sling procedures have become the surgical treatment of choice for female stress urinary incontinence. Innovative modifications of mid urethral sling procedures were recently introduced with the claim of offering similar efficacy and decreased morbidity. We compared the efficacy and morbidity of an innovative single incision mid urethral tape and an established transobturator procedure. MATERIALS AND METHODS: We performed a prospective, randomized, controlled trial in 6 teaching hospitals in Belgium and The Netherlands between 2007 and 2009. A total of 96 patients received a TVT Secur™ single incision sling and 98 received a TVT™ Obturator System. We collected data on patient characteristics, surgery related parameters, adverse events, clinical followup, Urogenital Distress Inventory and SF-36® scores, validated questionnaires on daily life activities and visual analog scores objectifying pain. Followup was 1 year. RESULTS: One-year followup was available for 75 single incision sling and 85 obturator system cases. Stress urinary incontinence could be objectified in 16.4% of the patients with a single incision sling and in 2.4% with an obturator system (p <0.05). Stress urinary incontinence was subjectively reported by 24% of single incision sling and 8% of obturator system patients (p <0.05). One year after surgery the mean ± SD UDI incontinence domain score in the single incision sling and obturator system groups was 21 ± 24 and 13 ± 21, respectively (p <0.01). Patients with a single incision sling experienced significantly less pain during the first 2 weeks after surgery (p <0.05) and returned significantly earlier to normal daily activity. The OR of re-intervention for stress urinary incontinence 1 year after receiving a single incision sling vs an obturator system was 2.3 (95% CI 1.9-2.7). CONCLUSIONS: The single incision sling procedure is associated with less postoperative pain and a lower objective cure rate than the obturator system procedure.

Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes.

OBJECTIVE: To evaluate anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh. STUDY DESIGN: Prospective multicentre cohort study at 11 international sites. One hundred twenty-seven patients with pelvic organ prolapse stage ≥ III had surgery and were evaluated at 3 months and 1-year postsurgery compared with baseline. Instruments of measurements: Pelvic Organ Prolapse Quantification, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12, and Patients Global Impression of Change. RESULTS: Anatomic success, defined as prolapse stage ≤ I in the treated vaginal compartments, was 77.4% (95% confidence interval, 69.0-84.4%). Significant improvements in bother, quality of life, and sexual function were detected at 3 months and 1 year compared with baseline. At 1-year after surgery, 86.2% of patients indicated their prolapse situation to be "much better." Mesh exposure rate was 10.2% and rate of de novo dyspareunia 2% at 1 year. CONCLUSION: These results demonstrate improved anatomic support, associated with excellent functional improvements, without apparent safety concerns.

An anatomic comparison of the original versus a modified inside-out transobturator procedure.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the modification of a shortened tape and reduced dissection of the inside-out transobturator procedure on the tape's relationship to the relevant anatomical structures. METHODS: In ten fresh frozen cadavers, relevant distances between the two different tapes and anatomical structures were recorded. RESULTS: The shorter tape traversed less muscular structures, but consistently traversed the obturator membrane. The median distance from the tape to the obturator canal measured 2.0 versus 1.9 cm, to the anterior obturator nerve 3.0 versus 2.7 cm, and to the posterior obturator nerve 2.2 versus 2.0 cm [modified versus original procedure, respectively (p > 0.05)]. Significantly, less mesh was inserted in the modified procedure on each side of the body (6.1 versus 9.9 cm, p < 0.05). CONCLUSIONS: The shorter, inside-out transobturator tape traverses less muscular structures than its original counterpart, while still consistently anchoring in the obturator membrane at a similarly safe distance from the obturator canal.

Trends in the diffusion of robotic surgery in prostate, uterus, and colorectal procedures: a retrospective population-based study.

This study aimed to propose quantifiable metrics on the adoption lifecycle of robotic-assisted surgery (RAS) within and across prostate, hysterectomy, and colorectal procedures. This was a retrospective population-based cohort study of commonly performed RAS procedures in the US conducted from July 2001 to July 2015. The patients were identified from the Premier Hospital Database using International Classification of Diseases, 9th revision, Clinical Modification codes denoting prostate, uterus, and colorectal procedures. The Diffusion of Innovations theory was applied to percent RAS utilization to determine discrete eras of technology adoption. Overall and by-era patient baseline characteristics were compared between robotic and non-robotic groups. This study included a total of 2,098,440 RAS procedures comprising prostate (n = 155,342), uterus (n = 1,300,046), and colorectal (n = 643,052) procedures. Prostate (76.7%) and uterus (28.9%) procedures had the highest robotic utilization by the end of the study period and appear to be in the last adoption era (Laggard). However, robotic utilization in colorectal procedures (7.5%) was low and remained in the first era (Innovator) for a longer time (15 vs 60 vs 135 months). Whites, privately insured, patients with fewer comorbidities, and those admitted in large teaching hospitals were more likely to undergo RAS in the early study period. AS-associated patient and hospital profiles changed over time, suggesting that selected patient cohorts should be contextualized by overall adoption of a novel medical technology. The time-discretized analysis may also inform patient selection criteria and appropriate timing for clinical study stages proposed by the Idea, Development, Exploration, Assessment, Long-term study-Devices framework.

Tumor Treating Fields for Glioblastoma Therapy During the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic has placed excessive strain on health care systems and is especially evident in treatment decision-making for cancer patients. Glioblastoma (GBM) patients are among the most vulnerable due to increased incidence in the elderly and the short survival time. A virtual meeting was convened on May 9, 2020 with a panel of neuro-oncology experts with experience using Tumor Treating Fields (TTFields). The objective was to assess the risk-to-benefit ratio and provide guidance for using TTFields in GBM during the COVID-19 pandemic. PANEL DISCUSSION: Topics discussed included support and delivery of TTFields during the COVID-19 pandemic, concomitant use of TTFields with chemotherapy, and any potential impact of TTFields on the immune system in an intrinsically immunosuppressed GBM population. Special consideration was given to TTFields' use in elderly patients and in combination with radiotherapy regimens. Finally, the panel discussed the need to better capture data on COVID-19positive brain tumor patients to analyze longitudinal outcomes and changes in treatment decision-making during the pandemic. EXPERT OPINION: TTFields is a portable home-use device which can be managed via telemedicine and safely used in GBM patients during the COVID-19 pandemic. TTFields has no known immunosuppressive effects which is important during a crisis where other treatment methods might be limited, especially for elderly patients with multiple co-morbidities. It is too early to estimate the full impact of COVID-19 on the global healthcare system and on patient outcomes and the panel strongly recommended collaboration with existing cancer COVID-19 registries to follow CNS tumor patients.

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical outcomes at 3 years following total transvaginal mesh (TVM) technique to treat vaginal prolapse. METHODS: Prospective, observational study in patients with prolapse ≥ stage II. Success was defined as POP-Q-stage 0-I and absence of surgical re-intervention for prolapse. Secondary outcome measures were: quality of life (QOL), prolapse-specific inventory (PSI), impact on sexual activity and complications. RESULTS: Ninety women underwent TVM repair, 72 a hysterectomy. Anatomical failure rate was 20.0% at 3 years. Three patients required re-intervention for prolapse. Improvements in QOL- and PSI-scores were observed at 1 and 3 years. Vaginal mesh extrusion occurred in 14.4% patients. After 3 years, 4.7% asymptomatic extrusions remained present. Of 61 sexually active women at baseline, a significant number of patients (41%) ceased sexual activity by 3 years; de novo dyspareunia was reported by 8.8%. One vesico-vaginal fistula resolved after surgery. CONCLUSION: Medium-term results demonstrate that the TVM technique provides a durable prolapse repair.

Individualized decreasing-dose maintenance fluconazole regimen for recurrent vulvovaginal candidiasis (ReCiDiF trial).

OBJECTIVE: Although many women with recurrent vulvovaginal candidiasis initially benefit from prophylactic intermittent treatment with antimycotics, most of them experience relapse after cessation of therapy, and often they return to the pretreatment recurrence rate. The purpose of this study was to demonstrate the efficacy and safety of an individualized, degressive, prophylactic regimen in 136 women with recurrent vulvovaginal candidiasis. STUDY DESIGN: After an induction dose of 600 mg fluconazole during the first week, 117 women started maintenance therapy: 200 mg fluconazole weekly for 2 months, followed by 200 mg biweekly for 4 months, and 200 mg monthly for 6 months, according to their individual response to therapy. All women were tested for recurrences monthly with wet mount microscopy and vaginal culture during the first 6 months and bimonthly during the next 6 months. Patients were allowed to move on to the next level of maintenance therapy only if they were symptom free and microscopy and culture negative. RESULTS: Of the women who were cured successfully after the induction phase, 101 women (90%) were disease-free after 6 months of maintenance therapy with this degressive regimen, and 80 women (77%) were disease-free after 1 year. The weekly incidence of the first clinical relapse was 0.5% during any period of the maintenance phase, and the rate of all new relapses, which included evidence of mycologic or microscopic colonization, was 1% per week. Women who experienced several relapses (poor responders) had experienced more relapses before entering the study compared with the optimal responders (odds ratio, 4.9; 95% CI,1.8-13.7; P = .002), experienced the disease for a longer period of time (6.5 vs 3.7 years; P = .06), and harbored significantly more Candida non-albicans during maintenance therapy (P = .001). No serious side-effects were noted. CONCLUSION: Individualized, degressive, prophylactic maintenance therapy with oral fluconazole is an efficient treatment regimen to prevent clinical relapses in women with recurrent vulvovaginal candidiasis.

Preclinical evaluation of the effect of the combined use of the Ethicon Securestrap® Open Absorbable Strap Fixation Device and Ethicon Physiomesh™ Open Flexible Composite Mesh Device on surgeon stress during ventral hernia repair.

Aim: To evaluate whether performing ventral hernia repairs using the Ethicon Physiomesh™ Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap® Open Absorbable Strap Fixation Device reduces surgical time and surgeon stress levels, compared with traditional surgical repair methods. Methods: To repair a simulated ventral incisional hernia, two surgeries were performed by eight experienced surgeons using a live porcine model. One procedure involved traditional suture methods and a flat mesh, and the other procedure involved a mechanical fixation device and a skirted flexible composite mesh. A Surgery Task Load Index questionnaire was administered before and after the procedure to establish the surgeons' perceived stress levels, and saliva samples were collected before, during, and after the surgical procedures to assess the biologically expressed stress (cortisol and salivary alpha amylase) levels. Results: For mechanical fixation using the Ethicon Physiomesh Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap Open Absorbable Strap Fixation Device, surgeons reported a 46.2% reduction in perceived workload stress. There was also a lower physiological reactivity to the intraoperative experience and the total surgical procedure time was reduced by 60.3%. Conclusions: This study provides preliminary findings suggesting that the combined use of a mechanical fixation device and a skirted flexible composite mesh in an open intraperitoneal onlay mesh repair has the potential to reduce surgeon stress. Additional studies are needed to determine whether a reduction in stress is observed in a clinical setting and, if so, confirm that this results in improved clinical outcomes.

Innovation Best Practices in the Medical Device Industry.

Advances in patient care often germinate from keen clinical insights and a needs-based approach to innovation. Although there is an important role for incremental improvements to existing solutions, transformational innovation is what truly drives real shifts in clinical outcomes and subsequently patient satisfaction, market access, and economic value. A good example of this is the evolution of the coronary stent market. The best innovation programs are focused on unmet needs rather than solutions, call for a careful articulation of the specific problems to be solved, involve a deep dive within a clinical area, and seek to prioritize research and development investments into areas where the greatest impact can be expected. To enhance its ability to pursue breakthrough innovation, Johnson and Johnson (J&J) has organized itself along priority disease areas, created the global J&J Innovation organization to pursue external technology and know-how, and continues to partner closely with clinical practitioners. The process undertaken at J&J to acquire a microwave ablation technology and enter the interventional oncology space is a recent case study of these innovation principles and organizational focus in action.

Prolonged Operative Duration Increases Risk of Surgical Site Infections: A Systematic Review.

BACKGROUND: The incidence of surgical site infection (SSI) across surgical procedures, specialties, and conditions is reported to vary from 0.1% to 50%. Operative duration is often cited as an independent and potentially modifiable risk factor for SSI. The objective of this systematic review was to provide an in-depth understanding of the relation between operating time and SSI. PATIENTS AND METHODS: This review included 81 prospective and retrospective studies. Along with study design, likelihood of SSI, mean operative times, time thresholds, effect measures, confidence intervals, and p values were extracted. Three meta-analyses were conducted, whereby odds ratios were pooled by hourly operative time thresholds, increments of increasing operative time, and surgical specialty. RESULTS: Pooled analyses demonstrated that the association between extended operative time and SSI typically remained statistically significant, with close to twice the likelihood of SSI observed across various time thresholds. The likelihood of SSI increased with increasing time increments; for example, a 13%, 17%, and 37% increased likelihood for every 15 min, 30 min, and 60 min of surgery, respectively. On average, across various procedures, the mean operative time was approximately 30 min longer in patients with SSIs compared with those patients without. CONCLUSIONS: Prolonged operative time can increase the risk of SSI. Given the importance of SSIs on patient outcomes and health care economics, hospitals should focus efforts to reduce operative time.

A systematic review and meta-analysis of Harmonic technology compared with conventional techniques in mastectomy and breast-conserving surgery with lymphadenectomy for breast cancer.

BACKGROUND: Mastectomy and breast-conserving surgery (BCS) are important treatment options for breast cancer patients. A previous meta-analysis demonstrated that the risk of certain complications can be reduced with the Harmonic technology compared with conventional methods in mastectomy. However, the meta-analysis did not include studies of BCS patients and focused on a subset of surgical complications. The objective of this study was to compare Harmonic technology and conventional techniques for a range of clinical outcomes and complications in both mastectomy and BCS patients, including axillary lymph node dissection. METHODS: A comprehensive literature search was performed for randomized controlled trials comparing Harmonic technology and conventional methods in breast cancer surgery. Outcome measures included blood loss, drainage volume, total complications, seroma, necrosis, wound infections, ecchymosis, hematoma, hospital length of stay, and operating time. Risk of bias was analyzed for all studies. Meta-analysis was performed using random-effects models for mean differences of continuous variables and a fixed-effects model for risk ratios of dichotomous variables. RESULTS: Twelve studies met the inclusion criteria. Across surgery types, compared to conventional techniques, Harmonic technology reduced total complications by 52% (P=0.002), seroma by 46% (P<0.0001), necrosis by 49% (P=0.04), postoperative chest wall drainage by 46% (P=0.0005), blood loss by 38% (P=0.0005), and length of stay by 22% (P=0.007). Although benefits generally appeared greatest in mastectomy patients with lymph node dissection, Harmonic technology showed significant reductions in complications in the BCS study subgroup. CONCLUSION: In this meta-analysis of both mastectomy and BCS procedures, the use of Harmonic technology reduced the risk of most complications by about half across breast cancer surgery patients. These benefits may be due to superior hemostatic capabilities of Harmonic technology and better dissection, particularly lymph node dissection. Reduction in complications and other resource outcomes may engender lower downstream health care costs.

Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device.

BACKGROUND AND OBJECTIVE: The Harmonic ACE+7 Shears with Advanced Hemostasis Mode (Ethicon, Somerville, NJ, USA) is an ultrasonic device designed to transect and seal vessels up to 7 mm in diameter. The device applies an algorithm that optimizes ultrasonic energy delivery combined with a longer sealing cycle. The purpose of this study was to assess the initial clinical experience with the Harmonic device by evaluating large-vessel sealing during laparoscopic colectomy in consecutive cases. METHODS: This prospective, multicenter, observational series involved 40 adult patients who were to undergo elective laparoscopic colectomy where dissection and transection of the inferior mesenteric artery was indicated. The primary study endpoint was first-pass hemostasis, defined as a single activation of the Advanced Hemostasis Mode to transect and seal the inferior mesenteric artery. The use of any additional energy device or hemostatic product to establish or maintain hemostasis was noted. Patients were observed after surgery for ∼4 weeks for adverse events that were considered to be related to the study procedure or study device. Descriptive statistical analyses were performed for study endpoints. RESULTS: Forty patients underwent the laparoscopic colectomy procedure. First-pass hemostasis of the inferior mesenteric artery was achieved and maintained in all 40 patients, with no required additional hemostatic measures. Exposure of the vessel was reported as skeletonized in 22 of 40 (55%) patients. Mean transection time was 21.9 ± 7.4 s. One adverse event (postoperative anemia) was considered possibly related to the study device. CONCLUSION: In this initial clinical consecutive series, the device demonstrated successful transection and sealing of the large mesenteric vessels during laparoscopic colorectal surgery.

Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode.

OBJECTIVE(S): The ultrasonic advanced energy study device (AH device) is the first surgical device indicated to seal vessels up to and including 7mm using ultrasonic technology alone. This study assesses clinical experience during total laparoscopic hysterectomy (TLH) using advanced hemostasis mode (AHM). STUDY DESIGN: This was a prospective, non-randomized, single arm, multicenter, observational study which did not modify or influence current surgeon technique for elective TLH for benign disease. Each surgeon assessed hemostasis, defined as the hemostatic transection of the uterine vasculature (left/right) with at least one use of the AH device in AHM without the use of additional hemostatic measures other than the AH device. Patients were followed for 4-6 weeks after surgery. Vessel sealing performance was quantitatively assessed for transection and sealing of the uterine artery (UA), the uterine pedicle (UP; defined as cases where the UA could not be 'isolated') and the ovarian pedicle (OP) (when indicated). Adverse events (AEs) related to the AH device or procedures were collected. RESULTS: Forty patients underwent the procedure. Mean age was 49 years and mean body mass index was 28kg/m(2). Mean surgical duration was 88min. None required conversion to open procedure. Using only the AH device, hemostasis was achieved and maintained in 119 (94.4%) transections (both left and right sides of the UA/UP and OP). Additional hemostasis was achieved in 5 patients using conventional bipolar (4) or monopolar (1) energy. No patient required a blood transfusion postoperatively. Only one adverse event of pain was considered to be related to the use of the ultrasonic AH device during this study. CONCLUSION: These results support that the AH device with its AHM has clinical utility in sealing named vessels in TLH. The new algorithm to deliver energy in the AHM has the potential to reduce the need for additional hemostatic devices or products as well as the potential to reduce the need for multiple instrument changes during surgery.

Consistency and sealing of advanced bipolar tissue sealers.

OBJECTIVES: The aim of this study was to evaluate two commonly used advanced bipolar devices (ENSEAL(®) G2 Tissue Sealers and LigaSure™ Blunt Tip) for compression uniformity, vessel sealing strength, and consistency in bench-top analyses. METHODS: Compression analysis was performed with a foam pad/sensor apparatus inserted between closed jaws of the instruments. Average pressures (psi) were recorded across the entire inside surface of the jaws, and over the distal one-third of jaws. To test vessel sealing strength, ex vivo pig carotid arteries were sealed and transected and left and right (sealed) halves of vessels were subjected to burst pressure testing. The maximum bursting pressures of each half of vessels were averaged to obtain single data points for analysis. The absence or presence of tissue sticking to device jaws was noted for each transected vessel. RESULTS: Statistically higher average compression values were found for ENSEAL(®) instruments (curved jaw and straight jaw) compared to LigaSure™, P<0.05. Moreover, the ENSEAL(®) devices retained full compression at the distal end of jaws. Significantly higher and more consistent median burst pressures were noted for ENSEAL(®) devices relative to LigaSure™ through 52 firings of each device (P<0.05). LigaSure™ showed a significant reduction in median burst pressure for the final three firings (cycles 50-52) versus the first three firings (cycles 1-3), P=0.027. Tissue sticking was noted for 1.39% and 13.3% of vessels transected with ENSEAL(®) and LigaSure™, respectively. CONCLUSION: In bench-top testing, ENSEAL(®) G2 sealers produced more uniform compression, stronger and more consistent vessel sealing, and reduced tissue sticking relative to LigaSure™.

Clinical and economic burden of surgical site infection in hysterectomy.

BACKGROUND: Owing to a lack of current understanding of outcomes and costs by type of hysterectomy procedure, we attempt to quantify the incidence and impact of surgical site infection (SSI) in laparoscopic and non-laparoscopic approaches to abdominal and vaginal hysterectomy. METHODS: Patients whose data were contained in the Premier Perspectives Database of 600 hospitals in the United States were selected on the basis of a post-operative diagnosis of SSI and treatment with antibiotics. The incidence of SSI and associated hospital length of stay (LOS) and costs were estimated. The effect of SSI on readmission was also analyzed. RESULTS: Of 210,916 hysterectomies included in the study, 55% were open abdominal procedures. Although the overall incidence of SSI in hysterectomy was low, its incidence was greater in open abdominal hysterectomy than in other approaches to hysterectomy. Patients with an SSI experienced a three- to five-fold greater LOS, two-fold greater cost, and three-fold greater risk of hospital readmission than those without an SSI. CONCLUSIONS: This study provides clinical evidence in support of less invasive approaches to hysterectomy. In addition to other documented benefits of such less invasive procedures, the lower incidence of SSIs and lower rates of associated complications and costs with these procedures than with open abdominal hysterectomy should be taken into account when weighing the risks and benefits of a surgical approach for patients whose condition warrants hysterectomy.