Cumulative Complication Rate Research Articles

Predictors of Safety and Efficacy of 2-Stage Hepatectomy for Bilateral Colorectal Liver Metastases

In patients with bilateral colorectal liver metastases (CLM) not resectable in 1 operation, 2-stage hepatectomy is the standard surgical approach. The objective of this study was to determine factors associated with safety and efficacy of 2-stage hepatectomy. The study included all 109 patients for whom 2-stage hepatectomy for CLM was planned during 2003 to 2014. The RAS mutation status and other clinicopathologic factors were evaluated for association with major complications and survival using multivariate analysis. Two-stage hepatectomy was completed in 89 of 109 patients (82%). Reasons for dropout after the first stage were disease progression (n= 12), insufficient liver growth (n= 5), and complications after first stage or portal vein embolization (n= 3). More than 6 cycles of preoperative chemotherapy were associated with failure to proceed to the second stage (p= 0.009). Rates of major complications (26% vs 6%; p < 0.001) and 90-day mortality (7% vs 0%; p= 0.006) were higher after the second stage. The cumulative rate of major complications was 15% (n= 29). Factors independently associated with major complications were rectal primary tumor, metachronous CLM, and more than 1 lesion resected at first stage. At median follow-up of 29.5 months, 3-year (68% vs 6%; p < 0.001) and 5-year overall survival rates (49% vs 0%; p < 0.001) were better after 2-stage hepatectomy completion than noncompletion. Factors independently associated with poor overall survival were rectal primary tumor (p= 0.044), more than 5 CLMs (p= 0.043), need for chemotherapy after first stage (p= 0.046), and RAS mutation (p < 0.001). The RAS mutation independently predicts the oncologic efficacy of 2-stage hepatectomy and may help guide patient selection for this aggressive surgical strategy.

Preoperative Biliary Drainage in Cases of Borderline Resectable Pancreatic Cancer Treated with Neoadjuvant Chemotherapy and Surgery.

Objective. To elucidate the optimum preoperative biliary drainage method for patients with pancreatic cancer treated with neoadjuvant chemotherapy (NAC). Material and Methods. From January 2010 through December 2014, 20 patients with borderline resectable pancreatic cancer underwent preoperative biliary drainage and NAC with a plastic or metallic stent and received NAC at Hiroshima University Hospital. We retrospectively analyzed delayed NAC and complication rates due to biliary drainage, effect of stent type on perioperative factors, and hospitalization costs from diagnosis to surgery. Results. There were 11 cases of preoperative biliary drainage with plastic stents and nine metallic stents. The median age was 64.5 years; delayed NAC occurred in 9 cases with plastic stent and 1 case with metallic stent (p = 0.01). The complication rates due to biliary drainage were 0% (0/9) with metallic stents and 72.7% (8/11) with plastic stents (p = 0.01). Cumulative rates of complications determined with the Kaplan-Meier method on day 90 were 60% with plastic stents and 0% with metallic stents (log-rank test, p = 0.012). There were no significant differences between group in perioperative factors or hospitalization costs from diagnosis to surgery. Conclusions. Metallic stent implantation may be effective for preoperative biliary drainage for pancreatic cancer treated with NAC.

Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel in patients with locally advanced uterine cervical cancer: The JACCRO GY-01 trial

ObjectiveA multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer. MethodsPatients with FIGO stage III–IVA uterine cervical cancer without para-aortic lymphadenopathy were enrolled. Patients received definitive radiotherapy (RT) consisting of external beam whole-pelvic RT and high-dose-rate intracavitary brachytherapy. The cumulative linear quadratic equivalent dose was 62–65Gy prescribed at point A. weekly CDDP at 30mg/m2 and PTX at 50mg/m2 were administered concurrently with RT for ≥5 courses. ResultsSixty-eight of the 70 registered patients were eligible. The complete response rate was 76.5% (95% confidence interval [CI], 66.4–86.6%). With a median follow-up of 27months (range, 7.9–33.5), the 2-year cumulative progression-free survival and the 2-year cumulative overall survival rates were 83.8% (95% CI, 75.1–92.6%) and 92.7% (95% CI, 86.4–98.9%), respectively. The pelvic cumulative disease progression-free and the 2-year cumulative distant metastasis rates were 89.6% (95% CI, 82.3–96.9%) and 13.2% (95% CI, 5.2–21.3%), respectively. The 2-year cumulative late complication rates were 25% for all grades, 13.2% for grade 1, 5.9% for grade 2, 2.9% for grade 3, and 2.9% for grade 4. ConclusionsFor locally advanced cervical cancer, CCRT with weekly CDDP 30mg/m2 and PTX at 50mg/m2 demonstrated favorable antitumor activity, and was feasible and safe with respect to the protocol-specified serious adverse reactions and events. Evaluation of this regimen in phase III trials is warranted.

Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up

To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up. Multicenter, prospective randomized clinical trial. setting: Sixteen international clinical centers. Two hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg. Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350. Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications. Late complications developed in 56 subjects (46.8 ± 4.8 5-year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5-year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P = .082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .034), although this was largely driven by subjects who had tube occlusions in the 2 groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P = .037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .04). Long-term rates of vision-threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than in the Ahmed Glaucoma Valve group over 5 years of follow-up.

Tumeurs malignes ophtalmologiques : indications de la radiothérapie et techniques

A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer.Patients with FIGO stage III–IVA uterine cervical cancer without para-aortic lymphadenopathy were enrolled. Patients received definitive radiotherapy (RT) consisting of external beam whole-pelvic RT and high-dose-rate intracavitary brachytherapy. The cumulative linear quadratic equivalent dose was 62–65 Gy prescribed at point A. weekly CDDP at 30 mg/m2 and PTX at 50 mg/m2 were administered concurrently with RT for ≥ 5 courses.Sixty-eight of the 70 registered patients were eligible. The complete response rate was 76.5% (95% confidence interval [CI], 66.4–86.6%). With a median follow-up of 27 months (range, 7.9–33.5), the 2-year cumulative progression-free survival and the 2-year cumulative overall survival rates were 83.8% (95% CI, 75.1–92.6%) and 92.7% (95% CI, 86.4–98.9%), respectively. The pelvic cumulative disease progression-free and the 2-year cumulative distant metastasis rates were 89.6% (95% CI, 82.3–96.9%) and 13.2% (95% CI, 5.2–21.3%), respectively. The 2-year cumulative late complication rates were 25% for all grades, 13.2% for grade 1, 5.9% for grade 2, 2.9% for grade 3, and 2.9% for grade 4.For locally advanced cervical cancer, CCRT with weekly CDDP 30 mg/m2 and PTX at 50 mg/m2 demonstrated favorable antitumor activity, and was feasible and safe with respect to the protocol-specified serious adverse reactions and events. Evaluation of this regimen in phase III trials is warranted.

Prolonged use of tenofovir and entecavir in hepatitis B virus-related cirrhosis.

Limited data is available from India on outcome and efficacy of tenofovir and entecavir in hepatitis B virus (HBV)-related cirrhosis when used for prolonged time. We report the long-term efficacy and outcome of these antiviral drugs in patients with chronic HBV infection, with compensated or decompensated cirrhosis. We retrospectively analyzed laboratory and clinical data of 400 HBV-related cirrhotic patients without access to liver transplantation, who were treated with tenofovir/entecavir therapy, from January 2007 to January 2014. Two hundred and ten (52.5%) patients had at least one of the components of decompensation at baseline. Two hundred and twenty (55%) and 180 (45%) patients were initiated tenofovir and entecavir, respectively. Follow up period was 45 (12-68) months for tenofovir and 36 (11-60) months for entecavir. At the end of 1year, levels of HBV DNA <20IU/mL were achieved in 91.8 % and 88.8% of patients, and alanine aminotransferase normalized in 54.5 % and 55.5% of patients who received tenofovir and entecavir, respectively. At the last visit, Child-Turcotte-Pugh scores improved among 29.5% of patients who received tenofovir, 25% of those who received entecavir, and remained stable in 61.9 % and 65% patients, respectively, in both groups. The 5-year cumulative rate of liver decompensation, hepatocellular carcinoma, and cirrhosis-related complications were 3.1 %, 1.9 %, and 2.1% with an annual incidence of 0.8 %, 0.3 %, and 0.5% per person-year, respectively. Tenofovir and entecavir were effective and potent drugs for prolonged treatment of HBV cirrhosis and improved the overall clinical course.

In Reply: High-Risk Factors in Symptomatic Patients Undergoing Carotid Artery Stenting With Distal Protection: Buffalo Risk Assessment Scale (BRASS).

BACKGROUND Demographics and vascular anatomy may play an important role in predicting periprocedural complications in symptomatic patients undergoing carotid artery stenting (CAS). OBJECTIVE To predict factors associated with increased risk of complications in symptomatic patients undergoing CAS and to devise a CAS scoring system that predicts such complications in this patient population. METHODS A retrospective study was conducted that included patients who underwent CAS for symptomatic carotid stenosis during a 3-year period. Demographics and anatomic characteristics were subsequently correlated with 30-day outcome measures. RESULTS A total of 221 patients were included in the study. The cumulative rate of periprocedural complications was 7.2%, including stroke (3.2%), myocardial infarction (3.2%), and death (1.4%). Renal disease increased the risk of all complications. National Institutes of Health Stroke Scale score ≥10 at presentation, difficult femoral access, and diseased calcified aortic arch increased the risk of stroke and all complications. Type III aortic arch correlated with increased risk of stroke. Pseudo-occlusion and concentric calcification of the carotid artery increased the risk of myocardial infarction, death, and all complications. Carotid tortuosity and anatomy hostile to the deployment of distal protection devices increased the risk of stroke, myocardial infarction, death, and all complications. CONCLUSION Our results suggest that CAS should be avoided in patients with multiple anatomic risk factors. High presenting National Institutes of Health Stroke Scale score and renal disease also increase the complication risk. The CAS scoring system devised here is simple, reproducible, and clinically valuable in predicting complications risk in symptomatic patients undergoing CAS.

High-Risk Factors in Symptomatic Patients Undergoing Carotid Artery Stenting With Distal Protection: Buffalo Risk Assessment Scale (BRASS).

Demographics and vascular anatomy may play an important role in predicting periprocedural complications in symptomatic patients undergoing carotid artery stenting (CAS). To predict factors associated with increased risk of complications in symptomatic patients undergoing CAS and to devise a CAS scoring system that predicts such complications in this patient population. A retrospective study was conducted that included patients who underwent CAS for symptomatic carotid stenosis during a 3-year period. Demographics and anatomic characteristics were subsequently correlated with 30-day outcome measures. A total of 221 patients were included in the study. The cumulative rate of periprocedural complications was 7.2%, including stroke (3.2%), myocardial infarction (3.2%), and death (1.4%). Renal disease increased the risk of all complications. National Institutes of Health Stroke Scale score ≥10 at presentation, difficult femoral access, and diseased calcified aortic arch increased the risk of stroke and all complications. Type III aortic arch correlated with increased risk of stroke. Pseudo-occlusion and concentric calcification of the carotid artery increased the risk of myocardial infarction, death, and all complications. Carotid tortuosity and anatomy hostile to the deployment of distal protection devices increased the risk of stroke, myocardial infarction, death, and all complications. Our results suggest that CAS should be avoided in patients with multiple anatomic risk factors. High presenting National Institutes of Health Stroke Scale score and renal disease also increase the complication risk. The CAS scoring system devised here is simple, reproducible, and clinically valuable in predicting complications risk in symptomatic patients undergoing CAS.

Long-term follow-up of biliary complications after adult right-lobe living donor liver transplantation.

Long-term biliary complications after living donor liver transplantation (LDLT) are not well described in the literature. This study was undertaken to determine the long-term impact of biliary complications after adult right-lobe LDLT. This retrospective review analyzed an 11-yr experience of 344 consecutive right-lobe LDLTs with at least two yr of follow-up. Biliary leaks occurred in 50 patients (14.5%), and strictures occurred in 67 patients (19.5%). Cumulative biliary complication rates at 1, 2, 5, and 10 yr were 29%, 32%, 36%, and 37%, respectively. Most early biliary leaks were treated with surgical drainage (N = 29, 62%). Most biliary strictures were treated first with endoscopic retrograde cholangiography (42%). There was no association between biliary strictures and the number of ducts (hazard ratio [HR] 1.017 [0.65-1.592], p = 0.94), but freedom from biliary stricture was associated with a more recent era (2006-2010) (HR 0.457 [0.247-0.845], p = 0.01). Long-term graft survival did not differ between those who had or did not have biliary complications (66% vs. 67% at 10 yr). Biliary strictures are common after LDLT but may decline with a center's experience. With careful follow-up, they can be successfully treated, with excellent long-term graft survival rates.

Treatment of Haemorrhoids by Transanal Haemorrhoidal Dearterialization. Experience of Several Specialized Units

IntroductionMilligan–Morgan and Ferguson haemorrhoidectomy has been the gold standard treatment for symptomatic haemorrhoids for many years. However, escisional techniques are associated with a significant morbidity rate. In recent years, diverse techniques have been described in an attempt to decrease these complications. The guided transanal haemorrhoidal dearterialization THD) doppler is one of these techniques. We report our experience with this new technique. MethodsWe performed a prospective study of 475 patients from 5 hospitals from the National Health System, in Spain. The majority of these patients suffered from third grade haemorrhoids (256 [56%]) and underwent THD. We analyse and compare preoperative and postoperative results as well as the homogeneity of the technique between hospitals. ResultsSpinal anaesthesia was the most elected procedure by the anaesthetist (81.0%). Statistically significant differences were found between pre and postoperative symptoms (P=.03), with an overall improvement after surgery. The average hospitalisation was 0.4±0.3 days. The mean number of days of oral analgesics was 8.8±2.7 days. The cumulative complication rate is 16%. ConclusionTHD is a safe and easily reproducible procedure. Postoperative outcomes demonstrated a low rate of morbidity and recurrence together with early discharge; therefore, a rapid incorporation to daily activities was noted.

High Expression of Mannose-Binding Lectin and the Risk of Vascular Complications of Diabetes: Evidence from a Meta-Analysis.

Vascular inflammation associated with mannose-binding lectin (MBL) may be implicated in the pathogenesis of vascular complications in diabetes. The purpose of this study is to evaluate the association of MBL expression with vascular complications in diabetes. Data from published case-control studies on MBL expression and vascular complications of diabetes were collected up to September 30, 2014. Medline, Embase, and Chinese National Knowledge Infrastructure (CNKI) were searched using the key words "MBL or mannose-binding lectin or mannan-binding lectin," "diabetes or diabetic," and "vascular complication, vascular disease or angiopathy" to identify the articles published in English or Chinese. The combined odds ratio (OR) and 95% confidence interval (CI) for the cumulative rate of vascular complications in the cases of high-expression MBL versus that in cases of low-expression MBL were estimated using a fixed-effects model and a random-effects model. In total, 2,714 cases from 12 articles including 2,256 cases with high-expression MBL (≥ 400 μg/L) and 458 cases with low-expression MBL (< 400 μg/L) were reviewed. The cumulative vascular complication rates were 52.9% (1,194/2,256) in the cases with high expression and 38.4% (176/458) in those with low expression. The combined ORs were 1.6, with a 95% CI ranging from 1.24 to 2.08, in the fixed-effects model and 1.94, with a 95% CI from 1.00 to 3.76, in the random-effects model. High expression of MBL may be correlated with a significantly increased risk of vascular complications in diabetes. Thus MBL detection in diabetes is an effective and feasible method to predict vascular complications.

The clinical success of tooth- and implant-supported zirconia-based fixed dental prostheses. A systematic review.

The aim was to make an inventory of the current literature on the clinical performance of tooth- or implant-supported zirconia-based FDPs and analyse and discuss any complications. Electronic databases, PubMed.gov, Cochrane Library and Science Direct, were searched for original studies reporting on the clinical performance of tooth- or implant-supported zirconia-based FDPs. The electronic search was complemented by manual searches of the bibliographies of all retrieved full-text articles and reviews, as well as a hand search of the following journals: International Journal of Prosthodontics, Journal of Oral Rehabilitation, International Journal of Oral & Maxillofacial Implants and Clinical Oral Implants Research. The search yielded 4253 titles. Sixty-eight potentially relevant full-text articles were retrieved. After applying pre-established criteria, 27 studies were included. Twenty-three studies reported on tooth-supported and 4 on implant-supported FDPs. Five of the studies were randomised, comparing Y-TZP-based restorations with metal-ceramic or other all-ceramic restorations. Most tooth-supported FDPs were FDPs of 3-5 units, whereas most implant-supported FDPs were full arch. The majority of the studies reported on 3- to 5-year follow-up. Life table analysis revealed cumulative 5-year survival rates of 93.5% for tooth-supported and 100% for implant-supported FDPs. For tooth-supported FDPs, the most common reasons for failure were veneering material fractures, framework fractures and caries. Cumulative 5-year complication rates were 27.6% and 30.5% for tooth- and implant-supported FDPs, respectively. The most common complications were veneering material fractures for tooth- as well as implant-supported FDPs. Loss of retention occurred more frequently in FDPs luted with zinc phosphate or glass-ionomer cement compared to those luted with resin cements. The results suggest that the 5-year survival rate is excellent for implant-supported zirconia-based FDPs, despite the incidence of complications, and acceptable for tooth-supported zirconia-based FDPs. These results are, however, based on a relatively small number of studies, especially for the implant-supported FDPs. The vast majority of the studies are not controlled clinical trials and have limited follow-up. Thus, interpretation of the results should be made with caution. Well-designed studies with large patient groups and long follow-up times are needed before general recommendations for the use of zirconia-based restorations can be provided.

Long-term follow up of post-surgical tooth autotransplantation: a retrospective study.

The aim of the present retrospective study was to evaluate the long-term results of tooth autotransplantation using the survival and success rates of transplanted teeth as outcome variables. Thirty patients received a total of 44 transplants of immature teeth from 1987 to 1997. Seventeen of those patients with 25 transplants were recalled 10-20years after tooth transplantation for complete clinical and radiographic examinations, followed by questionnaires that examined the patients' degrees of satisfaction. The incidence of all types of complications was carefully analyzed. Success was defined as being free of all complications over the entire observation period. The long-term survival rate for transplants that were observed after at least 10years was 96%. The cumulative complication rate (pulpal, periodontal, and operative complication rates) after an observation period of 10-20years was 38.9%. Therefore, the success rate at 10years was 61.1%. The present study confirms that transplanted teeth have a high long-term survival rate and a lower long-term success rate. This procedure should be recommended and carried out in appropriate patients when necessary because it is the most biological approach, even though it is highly sensitive to technique.

Prevention of pancreatitis after papillary balloon dilatation by nasobiliary drainage: a randomized controlled trial.

Endoscopic papillary balloon dilation (EPBD) was associated with a higher rate of endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The purpose of this study was to determine whether placement of an endoscopic nasobiliary drainage (ENBD) catheter can also prevent PEP after EPBD. A total of 93 patients, who with proven common bile duct (CBD) stones, received EPBD were enrolled this trial. They were randomly divided into ENBD group (n = 45) and no-ENBD group (n = 48) according whether undergone an ENBD procedure after EPBD. Their demographics, laboratory, procedural data were collected, and pancreaticobiliary complications were followed. The number of patients with serum amylase levels above the normal upper limit (>180 U/L) did not differ between groups. However, compared with ENBD group, more patients in No-ENBD group had levels greater than three times the normal limit (>540 U/L) (11/48 vs 3/45, P = 0.0285), and more patients developed to PEP (7/48 vs 0/45, P = 0.0250). During follow-up, the numbers of patients undergone cholecystectomy, cholangitis and recurrence of CBD stones were similar. There was also no significant difference in the cumulative rate of recurrent pancreaticobiliary complications between the two groups (P = 0.452). EPBD followed by insertion of an ENBD catheter can prevent PEP, and routine ENBD catheter placement is recommended after an EPBD procedure.

Results of a Standardized Endoscopic Approach to Resection of Polyps >20 mm

Results of a Standardized Endoscopic Approach to Resection of Polyps >20 mm

Tratamiento de la enfermedad hemorroidal mediante desarterialización y hemorroidopexia. Experiencia de varias unidades especializadas☆

IntroductionMilligan-Morgan and Ferguson haemorrhoidectomy has been the gold standard treatment for symptomatic haemorrhoids for many years. However, escisional techniques are associated with a significant morbidity rate. In recent years, diverse techniques have been described in an attempt to decrease these complications. The guided transanal haemorrhoidal dearterialization THD) doppler is one of these techniques. We report our experience with this new technique. MethodsWe performed a prospective study of 475 patients from 5 hospitals from the National Health System, in Spain. The majority of these patients suffered from third grade haemorrhoids (256 [56%]) and underwent THD. We analyse and compare preoperative and postoperative results as well as the homogeneity of the technique between hospitals. ResultsSpinal anaesthesia was the most elected procedure by the anaesthetist (81.0%). Statistically significant differences were found between pre and postoperative symptoms (P=.03), with an overall improvement after surgery. The average hospitalization was 0.4±0.3 days. The mean number of days of oral analgesics was 8.8±2.7 days. The cumulative complication rate is 16%. ConclusionTHD is a safe and easily reproducible procedure. Postoperative outcomes demonstrated a low rate of morbidity and recurrence together with early discharge; therefore, a rapid incorporation to daily activities was noted.

Incidence and predictive factors for complications after uterine leiomyoma embolization.

What is the risk of complications after uterine leiomyoma embolization and what are the factors associated with complications? The cumulative risk of complications after embolization is relatively low even in the long term, but submucosal leiomyoma location may increase the risk. A broad spectrum of complications after leiomyoma embolization have been described with widely varying rates. There is uncertainty over the actual risk of complications and the factors associated with this risk. This was a prospective cohort study of 288 consecutive women undergoing leiomyoma embolization in the general gynaecology clinic of a university teaching hospital between January 2001 and December 2010. Complications occurring after embolization were categorized as major or minor according to the severity of their impact on health, the level of care required and the outcome. Cumulative complication rates were estimated by survival analysis and log-rank tests according to baseline variables. Multivariable Cox proportional hazards analysis was performed to adjust for confounders. There were 48 patients who experienced a complication at a median of 5 months (95% confidence interval, 4.1-11.4) after embolization. Complications were minor in 38 patients and major in 10 patients. The cumulative overall complication rate was 13% (95% CI, 9.0-17.0) at 6 months, 16% (95% CI, 11.0-20.0) at 1 year, 17% (95% CI, 12.0-22.0) at 3 years and 18% (95% CI, 12.9-22.8) at 5 years. The most frequent complication (19/48, 39.6%) was leiomyoma expulsion, which occurred spontaneously in 13 (68.4%) of these cases and required assistance in 6 (31.6%) cases. Eight (2.8%) patients underwent re-intervention, including six hysteroscopic myomectomies, one laparoscopic myomectomy and one hysteroscopic adhesiolysis, as a result of a complication. Submucosal leiomyoma location was the only baseline variable associated with an increased risk for complications [Hazard ratio (HR), 2.28, 95% CI, 1.24-4.18, P = 0.008]. Our population did not include women of African descent, who have been reported to be at higher risk of post-procedural complications compared with Causcasian women. If such women were involved in the study, higher morbidity rates might have been observed. Women with submucosal leiomyomas at the time of embolization are more likely to have post-procedural complications. This is important new information for counselling patients contemplating this therapeutic approach. The authors have no competing interests to declare. The study was not supported by any external grant.

STOP-Bang and the effect on patient outcome and length of hospital stay when patients are not using continuous positive airway pressure.

BackgroundIn patients undergoing surgical interventions under general anesthesia, obstructive sleep apnea syndrome (OSA) can cause serious perioperative cardiovascular or respiratory complications leading to fatal consequences, even sudden death. In this study we test the hypothesis that morbidly obese patients diagnosed by a polysomnography test and using continuous positive airway pressure (CPAP) therapy have fewer and less severe perioperative complications and a shorter hospital stay than patients who have a medical history that meets at least three STOP-Bang criteria and are not using CPAP therapy.MethodsPostoperative hospital stay and pulmonary complications were analyzed in three groups of morbidly obese patients undergoing bariatric surgery (Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy) between January 2009 and November 2013 (n = 693). Group A comprised 99 patients who were preoperatively diagnosed with OSA based on polysomnography results. These patients used CPAP therapy before and after surgery. Group B consisted of 182 patients who met at least three STOP-Bang criteria but who were not diagnosed with OSA based on polysomnography results. These patients did not use CPAP. Group C, the reference group, comprised 412 patients who scored one to two items on the STOP-Bang.ResultsDuring the perioperative period, Group B patients had a significantly (p < 0.001) higher cumulative rate of pulmonary complications, worse oxygen saturation, respiratory rates, and increased length of stay in hospital. There was also two cases of sudden death in this group.ConclusionBased on these results, we conclude that patients meeting at least three STOP-BANG criteria have higher postoperative complications and an increased length of hospital stay than patients using CPAP.

Two‐piece zirconia implants supporting all‐ceramic crowns: A prospective clinical study

ObjectivesThe aim of this prospective clinical study is to evaluate the safety and efficacy of a new all-ceramic implant system to replace missing teeth in partially edentulous patients.Material and methodsThirty-two partially edentulous, systemically healthy patients were treated with 49 two-piece zirconia implants (ZERAMEX® T Implant System). Zirconia abutments were connected with adhesive resin cement. Single-unit full-ceramic crowns were cemented. The cases have been followed for 588±174 days after loading (range 369–889 days). All patients have been re-evaluated 1 year after loading.ResultsThe cumulative survival rate 1 year after loading was 87% implants. All failures were the result of aseptic loosening, and no implants were lost after the first year. The results of the other cases were good, and the patients were very satisfied. The cumulative soft tissue complication rate was 0%, the cumulative technical complication rate was 4% implants, the cumulative complication rate for bone loss >2 mm was 0%, and the cumulative esthetic complication rate was 0%. Including the data from 20 patients treated with an earlier version of the system, an over-all 2-year cumulative survival rate of 86% was calculated for a total of 76 two-piece zirconia implants supporting all-ceramic crowns in 52 patients.ConclusionsReplacement of single teeth in the posterior area was possible with this new full-ceramic implant system. Failures were due to aseptic loosening.

A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD) implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV). IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing) whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487), IVD-B (n = 485) or NSV (n = 487) groups and underwent operation. Follow-up included visits at the 3rd–6th and 12th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations) and semen analysis. The subjects’ partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV) among the three groups (P > 0.05). The cumulative rates of complications at the 12th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method.