Increase In Major Complications Research Articles

It’s the procedure not the patient: the operative approach is independently associated with an increased risk of complications after rectal prolapse repair

This study compares 30-day outcomes following rectal prolapse repair, examining potential surgical and patient factors associated with perioperative complications. Using the NSQIP database, patients with rectal prolapse were categorized by surgical approach to repair (perineal or abdominal) and abdominal cases were further subdivided by procedure (resection compared with rectopexy alone). Univariate and multivariate analyses compared major and minor complication rates between the groups. Of 1275 patients, the perineal group (n=706, 55%) was older, with more comorbidity, than those undergoing an abdominal procedure. There were fewer minor (odd ratio (OR)=0.35; 95% confidence interval (CI), 0.20-0.60; P=0.0038) and major complications (OR=0.46; 95% CI, 0.31-0.80; P=0.0038) in the perineal compared with the abdominal cohort. There was a significant increase in major complications amongst patients undergoing a resection compared with rectopexy only (OR=2.15; 95% CI, 1.10-4.41; P=0.0299). There was no difference in major complications between abdominal rectopexy and a perineal approach, but the latter had a lower chance of minor complications (OR=0.47; 95% CI, 0.24-0.94; P=0.0287). A perineal approach is safer than an abdominal approach to the treatment of rectal prolapse. Regarding an abdominal operation, rectopexy has fewer major complications than resection.

Increased rates of wound complications with locking plates in distal fibular fractures

There is a growing use of locking compression plates in fracture surgery. The current study was undertaken to investigate the wound complication rates of locking versus non-locking plates in distal fibular fractures. During a 6-year study period all consecutive, closed distal fibular fractures treated with either a locking or a non-locking plate were included and retrospectively analysed for complication related to the fibula. A total of 165 patients received a one-third tubular plate and 40 patients were treated with a locking plate. The two groups were comparable with respect to patient characteristics (age, gender, smokers and diabetics), injury characteristics (affected side, fracture dislocations, number of fractured malleoli and classification) and operation characteristics (surgical delay and duration, use of a tourniquet and plate length). The wound complication rate was 5.5% in the conventional plating group, and 17.5% in the locking plate group (p=0.019). This difference was largely due to an increase in major complications, for which removal of the plate was necessary (p=0.008). There is a significant increase in wound complications in distal fibular fractures treated with a locking compression plate. In light of the current study, we would caution against the application of the currently used locking compression plates in the treatment of distal fibular fractures.

Evaluation of neoadjuvant “window of opportunity” trials with targeted therapy in patients with surgically resectable non-small cell lung cancer.

7060 Background: “Window of opportunity” trials administer a short course of targeted therapy (TT) prior to surgical resection. The purpose of this study was to assess the perioperative safety of this approach compared to standard therapy in early stage non-small cell lung cancer (NSCLC) patients. Methods: Patients (cstage I/II) enrolled in two clinical trials received either preoperative EGFR tyrosine kinase inhibitor (erlotinib, n=22) or VEGFR inhibitor (pazopanib, n=18), followed by surgical resection. These patients were propensity matched (1:2) using a logistic regression model to patients undergoing surgical resection alone. Preoperative time to resection, operative data, and postoperative complications were compared. Results: Patients were treated with neoadjuvant TT for a median of 21 days (range 11- 28). Time from first clinic visit to resection was significantly longer in this group than in control patients (48 vs. 25 days, p<0.0001). Despite the time delay, there was no significant increase in pathologic upstaging in the TT group compared to control (33% vs. 24%, p=0.38). There was no difference in operative time, blood loss, or thoracoscopic conversion rates between the TT and control groups (Table). There was no significant difference in the percentage of patients experiencing any complication (45% in TT group vs. 34% in control group, p=0.24) or in the overall rates of major complications (Table). There were no 30-day mortalities in either group. Conclusions: “Window of opportunity” trials are a powerful tool to assess response to TT in NSCLC patients, allowing for radiologic and pathologic assessment of treatment effects. Such trials can be safely undertaken prior to surgery in early stage NSCLC patients, with no increase in pathologic upstaging. Surgery can be performed safely in these patients with no increase in major complications. TT (N=40) Control (N=80) p value (Fisher's exact test) Operative factors Operative time (min.) 144 157 0.24 Estimated blood loss (cc) 205 195 0.79 Complications Any 45% 34% 0.24 Cardiovascular 20% 25% 0.65 Respiratory 23% 19% 0.64 Renal failure 0% 1% 1.0 Infectious 13% 8% 0.50 Operative 5% 1% 0.26 No significant financial relationships to disclose.

Complications associated with percutaneous renal biopsy in Spain, 50 years later

The renal biopsy is essential for the diagnostic of glomerular disease However, it is an aggressive procedure with risk of complications. The aim of our study was to evaluate the complications directly related to percutaneous renal biopsy procedure in our centre. This retrospective study was performed using the data obtained from all patients who underwent percutaneous renal biopsy of the native kidney from January 1992 to December 2008. A semiautomatic 18 G needle biopsy was used until 2004 and thereafter we used a 16 G needle. From January 2009 to January 2010 we prospectively analyzed changes induced by renal biopsy. We analysed age, sex, indication for biopsy, histopathological diagnosis, hypertension, serum creatinine, GFR-MDRD-4, proteinuria, hemoglobin pre and post biopsy. Minor complications were defined as a decrease in hemoglobin levels greater than 1 g/dL. Mayor complications were: need for blood transfusion, surgery, nephrectomy, angiography, embolization, or death. The renal biopsy was performed by the nephrologist with the help of ultrasound. Anticoagulant therapy was removed prior to the biopsy. Total number of renal biopsies were 867. Seven hundred and ninety five renal biopsies were performed between 1992 and 2008. The prospective part of the study included 70 additional biopsies. Considering all patients, the mean age was 46.8 ± 19 and 60.7% were male. There were only six major complications (0.75%). Three of these mayor complications occurred in liver transplanted patients and required vascular embolization or nephrectomy. The remaining 3 major complications were observed in: one patient with liver disease, another patient had trait of hemophilia and a third patient required nephrectomy which after examination demonstrated epithelioid hemangioma. During the prospective analysis the rate of major and minor complications did not change, 1.4 and 2.0 % respectively. Switching from 18 to 16 G biopsy needle did not result in an increase of major complications. Major complications derived from all renal biopsy during the last 18 years were observed in only 0.75-1.4 %. Major complications occurred mainly in liver transplant patients. The use of 16 G needle provided greater diagnostic yield than the 18 G and it did not cause an increase in complications.

Complications in abdominoplasty: A risk factor analysis

Abdominoplasty is one of the most popular body-contouring procedures. However, it is associated with a significant number of complications, the most common being seroma and wound-healing problems. In this study, we analysed postoperative complications following abdominoplasty and evaluated the presence of statistically significant correlations between pre-existing risk factors and postoperative complications. We carried out a retrospective chart review of all patients who underwent abdominoplasty from June 1994 to April 2004 at our institution. Patient demographics, risk factors (smoking, previous abdominal surgery, obesity, and male gender) and complications (minor and major) were noted from the patient's medical record. In all, 139 patients were included in the study (126 female and 13 male), with a mean age of 42.8 years at the time of surgery. Minor and major complications were seen in 40 (28.8%) and 16 patients (11.5%), respectively. Smoking and previous abdominal surgery were not associated with a significantly increased complication rate. However, patients without previous surgery displayed a significantly increased complication rate (43.2% vs. 22.1% for minor and 25% vs. 5.3% for major complications; p<0.05). Obesity (BMI >30 kg/m(2)) was associated with a significant increase in major complications (20.8% vs. 9.7%; p<0.05). Male gender was predisposed to increased minor and major complications; however, this was not statistically significant. Despite its popularity, abdominoplasty is still associated with a significant rate of complications. In particular, obese patients and those with no previous history of abdominal surgery seem to be at risk for complications. The role of male gender needs to be evaluated further.

The Role of Low-Molecular-Weight Heparins in Arterial Diseases: Optimizing Antithrombotic Therapy

On the basis of current evidence, all patients with acute coronary syndromes should receive optimized medical therapy, whether or not they ultimately undergo an invasive revascularization procedure, to improve both clinical outcomes and cost effectiveness. While standard aspirin and unfractionated heparin (UFH) have improved short-term outcomes, they do not eliminate the risk of recurrent ischemic episodes. The recent introduction of platelet fibrinogen receptor antagonists and low-molecular-weight heparins (LMWHs) has offered an opportunity to develop more aggressive antithrombotic regimens. The LMWHs have been thoroughly evaluated in unstable angina and non-Q wave myocardial infarction (UA/NQMI), and have demonstrated improved efficacy compared to standard UFH, without an increase in major complications caused by bleeding. Experience has also been gathered using LMWHs in other arterial diseases (such as pregnant patients with prosthetic heart valves) and as an adjunctive therapy with thrombolytics for acute myocardial infarction. Lastly, studies are currently underway evaluating LMWHs in patients with atrial fibrillation.

Standardized measurement of the future liver remnant prior to extended liver resection: Methodology and clinical associations

Background. There is no agreement regarding the preoperative measurement of liver volumes and the minimal safe size of the liver remnant after extended hepatectomy. Methods. In 20 patients with hepatobiliary malignancy and no underlying chronic liver disease, volumetric measurements of the liver remnant (segments 2 and 3 ± 1) were obtained before extended right lobectomy (right trisegmentectomy). The ratios of future liver remnant to total liver volume were calculated by using a formula based on body surface area. In 12 patients, response to preoperative right trisectoral portal vein embolization was evaluated. In 15 patients who underwent the planned resection, preoperative volumes were correlated with biochemical and clinical outcome parameters. Results. The future liver remnants increased after portal vein embolization (26% versus 36%, P <.01). Smaller size liver remnants were associated with an increase in postoperative liver function tests (P <.05) and longer lengths of hospital stay (P <.02). Preliminary data indicates an increase in major complications for liver volumes ≤25% (P =.02). Conclusions. A simple method of measurement provides an assessment of the liver remnant before resection. It is useful in evaluating response to portal vein embolization and in predicating the outcome before extended liver resections. (Surgery 2000;127:512–9.)

Fiberoptic Bronchoscopy in Coronary Care Unit Patients: Indications, Safety, and Clinical Implications

To evaluate the indications, safety, therapeutic impact, and outcome of fiberoptic bronchoscopy (FOB) in coronary care unit (CCU) patients. Retrospective review of all CCU patients undergoing FOB during a 6-year period. Tertiary care university hospital. Among 8,330 patients admitted to the CCU; 40 (0.5%) patients underwent FOB to evaluate pulmonary abnormalities, most often (78%) to appraise clinically suspected pneumonia. Thirty-five (88%) patients were intubated and 21 (53%) had acute myocardial infarction (MI) before FOB. There were two major complications (bleeding, intubation) occurring within 24 h of FOB, one of which appeared due to the procedure. No episodes of chest pain or ischemic events were recorded and no significant increase in major complications was noted in MI patients (3% vs 5%). Patients having FOB within 10 days of MI had higher survival (79%) than those undergoing FOB later (29%) (p = 0.05). Seven different bacterial pathogens were isolated in 6 (15%) patients, probably reflecting prior empiric antibiotics in 32 (80%) patients. Therapy was changed in 64% of patients in whom a potential pathogen was identified. Despite alterations in treatment, patients with clinically suspected pneumonia and any organisms isolated by FOB had greater mortality (79% vs 31%, p = 0.003) than those with sterile FOB cultures. FOB may be diagnostically useful in the evaluation of pulmonary abnormalities in selected patients with acute cardiac disease, can be performed safely, and may influence management decisions. Positive bronchoscopy cultures often influence therapy but are associated with higher mortality, suggesting a lethal effect of nosocomial pneumonia in this subset of CCU patients. The risks of FOB must be weighed with the impact of FOB results on patient outcome, and its role requires further investigation.

Risk Factors for Complications and Morbidity After Radical Retropubic Prostatectomy

Purpose With recognition of the efficacy of surgical therapy for prostate cancer, there has been a marked increase in the number of radical prostatectomies performed, and substantial changes in surgical technique and perioperative management have decreased the morbidity of this procedure. We assessed the rate of perioperative complications with time and the risk factors for these complications, particularly age, operative time and co-morbidity. Materials and Methods A detailed review of all medical records of a consecutive series of 472 patients treated with radical retropubic prostatectomy by 1 surgeon between 1990 and 1994 was performed to document any complication within 30 days postoperatively. American Society of Anesthesiologists (ASA) physical status classification recorded by the staff anesthesiologist was used as a standard index of co-morbidity. Results Major complications were identified in 46 patients (9.8%), minor complications in 101 (21.4%) and none in 341 (72.2%). There were 2 deaths (0.42%). Major complications were not associated with age, operative time or year of operation but were significantly associated with ASA class (p = 0.006) and operative blood loss (p = 0.015) in a logistic regression analysis. Only 16% of patients were assigned to ASA class 3, yet this group included both deaths, a 3-fold increase in major complications, prolonged hospital stay, greater need for intensive care unit admission and more frequent blood transfusions. Major complications were almost 3 times more frequent in class 3 (21.3%) than in class 1 or 2 (7.6%) cases (p <0.005). Minor complications significantly increased hospital stay by a mean of 26% and major complications by 47% (p <0.0001). Conclusions Radical retropubic prostatectomy was performed with no perioperative complication in 72% of patients. Major complications resulted in more intensive use of medical resources and were related to co-morbidity rather than age.

American Heart Association 68th Scientific Sessions, Anaheim, California, November 13 to 15, 1995.

Dr Elliott Antman, of Harvard Medical School and Brigham and Women’s Hospital in Boston, Massachusetts, presented the results of the Thrombolysis in Myocardial Infarction (TIMI) 9B study at a Satellite Symposium sponsored by George Washington University immediately prior to the American Heart Association Meetings in Anaheim, California, in November 1995. The TIMI 9 trial was a randomized, double-blind study conducted in 150 clinical centers that was designed to compare the efficacy and safety of intravenous heparin versus the direct-acting thrombin inhibitor hirudin in patients with acute myocardial infarction (<12 hours from onset) treated with a thrombolytic agent (streptokinase or tissue-type plasminogen activator [TPA], at the discretion of the treating physician). The TIMI 9A study (n=757) was suspended in April 1994 because of excessive bleeding in both the heparin and hirudin groups. The TIMI 9B trial was restarted in May 1994 with lower doses of both heparin and hirudin; enrollment (n=3002) continued through August 1995. The primary end point of the study was the 30-day incidence of death, myocardial infarction, congestive heart failure, and shock. At 30 days, there was no significant difference in the primary end point between heparin (11.8%) and hirudin (12.8%) and no difference in the incidence of death and myocardial infarction (9.3% in the heparin group, 9.6% in the hirudin group). Similarly, there was no significant difference in major bleeding events (including intracranial hemorrhage) between treatment groups. The TIMI 9 Investigators concluded that hirudin was equally effective as but not superior to heparin with respect to either clinical outcome or bleeding risk in patients with acute myocardial infarction receiving thrombolytic therapy. Also at the George Washington University Satellite Symposium, Dr Eugene Braunwald, of Harvard Medical School and Brigham and Women’s Hospital in Boston, presented the results of the TIMI 10A phase I trial. TIMI 10A is an …

The patterns of care outcome study for cancer of the uterine cervix results of the second national practice survey

This report summarizes the outcome results of the Patterns of Care Study (PCS) of cancer of the uterine cervix from 565 patients treated in 1978. The 5-year survival with no evidence of disease was: Stage I, 74%; Stage II, 56%; and Stage III, 33%. The 5-year local in-field failure rate was: Stage I, 12%, Stage II, 27%; and Stage III, 51%. Extent of parametrial involvement, unilateral versus bilateral, may be important in determining survival and local failure. The four-year actuarial survival was 58% for unilateral involvement versus 47% for bilateral (P = 0.06), and the local failure rate was 32% for unilateral versus 45% for bilateral (P less than 0.05). When analyzed by stage, patients with Stage IIb disease with unilateral parametrial involvement showed a trend toward improved survival and decreased local failure compared with those with bilateral Stage IIb cancers (P = 0.1). The use of intracavitary irradiation significantly improved survival and reduced local failures. Furthermore, the number of intracavitary applications was important. When two or more intracavitary applications were used compared with one application, local in-field failure was significantly reduced, 29% versus 17% at 4 years (P less than 0.001), and four-year survival was improved, 60% versus 73% (P = 0.01). The four-year actuarial rate of major complications depended on the stage: Stage I, 8%; Stage II, 15%; and Stage III, 13%. There was a statistically significant increase in major complications in patients undergoing laparotomy for staging versus no laparotomy 23% versus 11% at 4 years (P less than or equal to 0.01) and a trend toward increased major complications in patients who were thin or had prior abdominal surgery. This study confirmed the stage-dependent outcome of treatment of cancer of the uterine cervix with radiation and indicated that further division of Stage IIb to indicate prognostic significance of unilateral or bilateral parametrial involvement may be warranted. This study also confirmed the importance of intracavitary radiation in optimizing control established by the 1973 PCS. It further suggests that where possible, two intracavitary insertions may yield better results than one insertion.