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Abe Fingerhut

Publications and source records attributed to Abe Fingerhut.

At least 19 recordsLinked to original sources
PubMed2007

The role of data and safety monitoring in acute trauma resuscitation research.

BACKGROUND: The role of data and safety monitoring boards (DSMBs) in clinical research in acute trauma resuscitation is not well documented. Many of the difficulties conducting acute resuscitation research are exacerbated because multiinstitutional studies are needed to adequately power such research. STUDY DESIGN: The purpose of the study was to demonstrate how a well-organized DSMB, explicitly required for these types of clinical trials by many funding agencies, can be a valuable resource in their safe and successful conduct by maximizing data integrity and striving to standardize care by monitoring the consistent and accurate collection of data and adherence to protocol. As an example, the work of an external DSMB in an international multicenter trial of recombinant activated coagulation factor VIIa (rFVIIa) in blunt and penetrating trauma patients is presented. The DSMB in this study was responsible for reviewing all serious adverse event (SAE) data, performing an extended review of SAEs, and reviewing results of analyses of 48-hour and 30-day mortality according to prespecified study stopping rules. RESULTS: Application by the DSMB of uniform definitions of SAEs substantially improved the integrity of the study data and facilitated analysis of events, such as disseminated coagulopathy, pulmonary complications, and multiple organ failure. As a result of the DSMB's efforts, important insights were gained to guide site selection and conduct of future trials of rFVIIa in trauma-induced hemorrhage. CONCLUSIONS: Based on our experience as members of the study DSMB and on a review of the literature, we recommend a strong role for DSMBs in multicenter trials in acute resuscitative care.

Acute Disease↗
PubMed2006

Povidone-iodine vs sodium hypochlorite enema for mechanical preparation before elective open colonic or rectal resection with primary anastomosis: a multicenter randomized controlled trial.

HYPOTHESIS: The anti-infective actions of povidone-iodine (PVI) and sodium hypochlorite enemas are different. DESIGN: Prospective, randomized, single-blind study. SETTING: Multicenter. PATIENTS: Five hundred seventeen consecutive patients with colorectal carcinoma or sigmoid diverticular disease undergoing elective open colorectal resection, followed by primary anastomosis. INTERVENTION: All patients received senna (1-2 packages diluted in a glass of water) at 6 pm the evening before surgery. Patients were administered two 2-L aqueous enemas of 5% PVI (n = 277) or 0.3% sodium hypochlorite (n = 240) at 9 pm the evening before surgery and at 3 hours before operation. Intravenous ceftriaxone sodium (1 g) and metronidazole (1 g) were administered at anesthetic induction. MAIN OUTCOME MEASURE: Rate of patients with 1 infective parietoabdominal complication or more. RESULTS: The percentages of patients with 1 infective parietoabdominal complication or more did not differ between the 2 groups (13.7% in the PVI-treated group vs 15.0% in the sodium hypochlorite-treated group). Tolerance was better in the PVI-treated group than in the sodium hypochlorite-treated group (79.4% vs 67.9%), with fewer patients experiencing abdominal pain (13.0% vs 24.6%) or discontinuing their preparation (3.0% vs 9.0%) (P=.02 for all). There were more patients with malaise in the PVI-treated group than in the sodium hypochlorite-treated group (9.1% vs 4.9%, P<.05). Three patients in the sodium hypochlorite-treated group had necrotic ulcerative colitis. CONCLUSION: When antiseptic enemas are chosen for mechanical preparation before colorectal surgery, PVI should be preferred over sodium hypochlorite because of better tolerance and avoidance of necrotic ulcerative colitis.

Adult↗
PubMed2006

Risk factors for mortality and intra-abdominal complications after pancreatoduodenectomy: multivariate analysis in 300 patients.

BACKGROUND: Studies of risk factors after pancreatoduodenectomy are few: some concern restricted populations and others are based on administrative data. METHODS: Multicenter clinical data were collected for 300 patients undergoing pancreatoduodenectomy to determine (by univariate and multivariate analysis) preoperative and intraoperative risk factors for mortality and intra-abdominal complications (IACs), including pancreatic fistula. Fourteen factors including the center and volume effect were analyzed. RESULTS: In univariate analysis, mortality was increased with age 70 years or more, extended resection(s), and volume and center effects. IACs occurred more often with main pancreatic duct diameter of 3 mm or less, normal parenchyma texture, extended resection(s), and the center effect. Pancreatic fistula was more frequent with main pancreatic duct diameter of 3 mm or less, normal parenchyma texture, and the center effect. In multivariate analysis, independent risk factor(s) for mortality were age greater than 70 years (odds ratio [OR], 3; 95% confidence interval [CI], 1.3-8) and extended resection (OR, 5; 95% CI, 1.2-22), risk factors for IACs were extended resection (OR, 5; 95% CI, 1.2-22) and main pancreatic duct diameter of 3 mm or less (OR, 2; 95% CI, 1.1-3), and the risk factor for pancreatic fistula was main pancreatic duct diameter of 3 mm or less (OR, 2.5; 95% CI, 1.2-4.6). CONCLUSIONS: Age more than 70 years, extended resections, and main pancreatic duct diameter less than 3 mm are independent risk factors that should be considered in indications for and techniques of pancreatoduodenectomy.

Adult↗
PubMed2006

Massive transfusion practices around the globe and a suggestion for a common massive transfusion protocol.

BACKGROUND: Massive transfusion, the administration of 10 to more than 100 units of red blood cells (RBC) in less than 24 hours, can be a life saving therapy in the treatment of severe injury. The rapid administration of large numbers of RBC, along with sufficient plasma and platelets to treat or prevent coagulopathy, is frequently a disorderly process. Patient care and collaborative research might be aided with a common protocol. METHODS: The authors polled trauma organizations and trauma centers to find examples of massive transfusion protocols. The goals and ease of use of these protocols were evaluated. RESULTS: Massive transfusion protocols exist at a relatively small number of large and well-organized trauma centers. Most of these protocols are designed to treat pre-existing and/or ongoing coagulopathy. CONCLUSIONS: The evidence would suggest that prevention of coagulopathy is superior to its treatment. Simple ratios such as 1:1:1 RBC:plasma:platelets have the benefit of ease of use and the relatively higher plasma and platelet doses appear to be associated with improved outcome. Such a standard protocol can foster multicenter research on resuscitation and hemorrhage control. The fixed volume ratios might allow the number and rate of administered units of RBC to be used as surrogates for blood loss and primary treatment effect.

Australia↗
PubMed2006

Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile.

BACKGROUND: In recent years, the hemostatic agent recombinant factor VIIa (rFVIIa) has emerged as a potentially new therapeutic agent for management of coagulopathy in patients with cirrhosis or following severe traumatic injury, a complex problem for clinicians in which standard treatment strategies are not always effective. As with other hemostatic agents, a primary safety concern of rFVIIa therapy is the theoretical possibility that systemic administration could confer an increased risk of thrombotic complications. So far, clinical experience indicates rFVIIa to be a safe treatment for currently approved indications within hemophilia. Little information is available, however, for patient populations outside this clinical setting. STUDY DESIGN AND METHODS: This article reviews critical safety data obtained from 13 Novo Nordisk-sponsored clinical trials of rFVIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury. RESULTS: Thrombotic adverse events were reported for 5.3 percent (23/430) of placebo-treated patients and 6.0 percent (45/748) of patients on active treatment. No significant difference was found between placebo-treated and rFVIIa-treated patients with respect to the incidence of thrombotic AEs, either on an individual trial basis or for these trial populations combined (p=0.57). CONCLUSION: An important determinant for the safety profile reported here is likely to be the specific mechanism of action of rFVIIa, shown in experimental studies to be localized to the site of vascular injury where tissue factor is exposed.

Anticoagulants↗
PubMed2005

Fatal chest injury with lung evisceration during athletic games in ancient Greece.

The "Olympic idealism" that dominates modern athletic culture is a myth. The true aims of the athletes in ancient Greece were rewards and life-long appointments to various positions in the military or the city administration. Competitions in the athletic games included, among others, wrestling, boxing, and pangration (a combination of wrestling and boxing). Occasionally, these games resulted in severe trauma or death. Two cases of extreme violence resulting in fatal chest trauma are presented and commented on from both surgical and social points of view.

Athletic Injuries↗
PubMed2005

How to teach evidence-based surgery.

The objectives of teaching evidence-based surgery (EBS) are to inform and convince that EBS is a method of interrogation, reasoning, appraisal, and application of information to guide physicians in their decisions to best treat their patients. Asking the right, answerable questions, translating them into effective searches for the best evidence, critically appraising evidence for its validity and importance, and then integrating EBS with their patients' values and preferences are daily chores for all surgeons. Teaching and learning EBS should be patient-centered, learner-centered, and active and interactive. The teacher should be a model for students to become an expert clinician who is able to match and take advantage of the clinical setting and circumstances to ask and to answer appropriate questions. The process is multistaged. Teaching EBS in small groups is ideal. However, it is time-consuming for the faculty and must be clearly and formally structured. As well, evidence-based medicine (EBM) courses must cater to local institutional needs, must receive broad support from the instructors and the providers of information (librarians and computer science faculty), use proven methodologies, and avoid scheduling conflicts. In agreement with others, we believe that the ideal moment to introduce the concepts of EBM into the curriculum of the medical student is early, during the first years of medical school. Afterward, it should be continued every year. When this is not the case, as in many countries, it becomes the province of the surgeon in teaching hospitals, whether they are at the university, are university-affiliated, or not, to fulfill this role.

Decision Making↗
PubMed2005

Patient's preference and randomization: new paradigm of evidence-based clinical research.

The limitations associated with the traditional randomized controlled design as applied to clinical surgical research must be recognized. The aim of randomization is to ensure initial comparability between groups of eligible patients for whom treatments are compared, thus eliminating their individual influence on outcome. Randomized controlled trials in the surgical literature are sparse; patient preferences might be a major obstacle to their performance. External validity of results of clinical trials depends on the representativity of patients who participate in trials: Compliance to participate through informed consent may act as a selection bias. In surgical randomized trials where it is not often possible for patients to remain blinded to the treatment to which they have been allocated, patient preferences can influence the effectiveness of treatments. In this setting, we need to look at alternatives and the potential advantages of adopting more flexible and clinically relevant approaches to the design of surgical trials. We have to accept the weight of the patient's individual decision in everyday practice. Hence, to negate the importance of these individual choices when evaluating surgical outcomes is unrealistic. An original design reported herein might become a new paradigm for surgical evaluation.

Ethics, Clinical↗
PubMed2005

A controlled randomized multicenter trial of pancreatogastrostomy or pancreatojejunostomy after pancreatoduodenectomy.

BACKGROUND: Only 2 large (more than 100 patients) prospective trials comparing pancreatogastrostomy (PG) with pancreatojejunostomy (PJ) after pancreatoduodenectomy (PD) have been reported until now. One nonrandomized study showed that there were less pancreatic and digestive tract fistula with PG, whereas the other, a randomized trial from a single high-volume center, found no significant differences between the two techniques. METHODS: Single blind, controlled randomized, multicenter trial. The main endpoint was intra-abdominal complications (IACs). RESULTS: Of 149 randomized patients, 81 underwent PG and 68 PJ. No significant difference was found between the two groups concerning pre- or intraoperative patient characteristics. The rate of patients with one or more IACs was 34% in each group. Twenty-seven patients sustained a pancreatoenteric fistula (18%), 13 in PG (16%; 95% confidence interval [CI] 8-24%) and 14 in PJ (20%; 95% CI 10.5-29.5%). No statistically significant difference was found between the 2 groups concerning the mortality rate (11% overall), the rate of reoperations and/or postoperative interventional radiology drainages (23%), or the length of hospital stay (median 20.5 days). Univariate analysis found the following risk factors: (1) age > or =70 years old, (2) extrapancreatic disease, (3) normal consistency of pancreas, (4) diameter of main pancreatic duct <3 mm, (5) duration of operation >6 hours, and (6) a center effect. Significantly more IAC, pancreatoenteric fistula, and deaths occurred in one center (that included the most patients) (P = .05), but there were significantly more high-risk patients in this center (normal pancreas consistency, extrapancreatic pathology, small pancreatic duct, higher transfusion requirements, and duration of operation >6 hours) compared with the other centers. In multivariate analysis, the center effect disappeared. Independent risk factors included duration of operation >6 hours for IAC and for pancreatoenteric fistula (P = .01), extrapancreatic disease for pancreatoenteric fistulas (P < .04), and age > or =70 years for mortality (P < .02). CONCLUSIONS: The type of pancreatoenteric anastomosis (PJ or PG) after PD does not significantly influence the rate of patients with one or more IAC and/or pancreatic fistula or the severity of complications.

Adult↗
PubMed2005

Postoperative pancreatic fistula: an international study group (ISGPF) definition.

BACKGROUND: Postoperative pancreatic fistula (POPF) is still regarded as a major complication. The incidence of POPF varies greatly in different reports, depending on the definition applied at each surgical center. Our aim was to agree upon an objective and internationally accepted definition to allow comparison of different surgical experiences. METHODS: An international panel of pancreatic surgeons, working in well-known, high-volume centers, reviewed the literature on the topic and worked together to develop a simple, objective, reliable, and easy-to-apply definition of POPF, graded primarily on clinical impact. RESULTS: A POPF represents a failure of healing/sealing of a pancreatic-enteric anastomosis or a parenchymal leak not directly related to an anastomosis. An all-inclusive definition is a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of POPF (grades A, B, C) are defined according to the clinical impact on the patient's hospital course. CONCLUSIONS: The present definition and clinical grading of POPF should allow realistic comparisons of surgical experiences in the future when new techniques, new operations, or new pharmacologic agents that may impact surgical treatment of pancreatic disorders are addressed.

Humans↗
PubMed2004

Treatment of hydatid cyst of the liver: where is the evidence?

Treatment of hydatid cyst of the liver ranges from surgical intervention (conventional or laparoscopic approach) to percutaneous drainage and to medical therapy. The aim of this systematic review was to provide "evidence-based" answers to the following questions: Should chemotherapy be used alone or in association with surgery? What is the best surgical technique? When is the percutaneous aspiration injection and reaspiration technique (PAIR) indicated? An extensive electronic search of the relevant literature without limiting it to the English language was carried out using MEDLINE and the Cochrane Library. Key words used for the final search were "hydatid cyst," "liver," "treatment," "meta analysis," "randomized controlled trial," "prospective study," "retrospective study." All relevant studies reporting the assessment of one modality of treatment or a comparison of two or several therapeutic methods to treat hydatid cyst of the liver and published in a peer-reviewed journal were considered for analysis. This systematic review allowed us to conclude that chemotherapy is not the ideal treatment for uncomplicated hydatid cysts of the liver when used alone (level II evidence, grade B recommendation). The level of evidence was too low to help decide between radical or conservative treatment (level IV evidence, grade C recommendation). Omentoplasty associated with radical or conservative treatment is efficient in preventing deep abscesses (level II evidence, grade A recommendation). The laparoscopic approach is safe (level IV evidence, grade C recommendation). Drug treatment associated with surgery (level II evidence, grade C recommendation) requires further studies. Percutaneous drainage associated with albendazole therapy is safe and efficient in selected patients (level II evidence, grade B recommendation). The level of evidence is low concerning treatment of complicated cysts.

Albendazole↗
PubMed2004

Prognostic factors for early gastric cancer in France: Cox regression analysis of 332 cases.

Early gastric cancer (EGC) is defined as a lesion in which the depth of invasion is limited to the mucosa, submucosa, or both regardless of lymph node status; moreover, it has an excellent prognosis, with a 5-year survival rate of more than 90%. We aimed to determine the prognostic factors for EGC in a large Western series. Over a 10-year period from January 1979 to December 1988 a series of 332 patients (mean age 64 years) with EGC were operated on in 23 centers (two French Associations for Surgical Research). The clinicopathologic data retrospectively and screened it for prognostic effect. The mean follow-up for the 332 EGC patients was 80 months. Postoperative mortality was 4% among 243 partial and 89 total gastric resections. The overall 5- and 7-year survival rates were 82% and 72%, respectively. The cumulative 5- and 7-year survival rates (mean follow-up 80 months) were 92.0% and 87.5%, respectively, excluding both operative and unrelated mortality. There was no significant difference in survival between partial and total gastric resection for lesions located in the lower third of the stomach ( p > 0.6). When survival data (excluding postoperative deaths) were analyzed using univariate analysis and Cox's proportional hazards model, lymphatic involvement ( p = 0.01), the site of the tumor in the upper two-thirds of the stomach ( p = 0.02), and submucosal lesions ( p = 0.049) showed a significant effect on predicting a poor prognosis. These results suggest that because of its prognostic value lymphadenectomy should be performed in addition to gastric resection for adequate classification of EGCs. Follow-up might be required only for patients with at least one poor prognostic factor.

Adenocarcinoma↗
PubMed2004

Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial.

HYPOTHESIS: Prophylactic administration of octreotide acetate decreases the rate of postoperative intra-abdominal complications (IACs) after elective pancreatic resection. DESIGN: Single-blind, controlled, randomized trial. SETTING: Multicenter (N = 20) trial in France. PATIENTS: Of 230 randomized patients undergoing pancreatoduodenectomy and pancreatic enteric anastomosis or distal pancreatectomy for either malignant or benign tumor or chronic pancreatitis, 122 were allotted intraoperatively to receive octreotide; 108 served as controls. RESULTS: All 230 patients were analyzed. Both groups were comparable except that significantly more patients in the octreotide group had biological glue injected into the main pancreatic duct alone (P<.001) or reinforcing the pancreatic enteric anastomosis (68% [83/122] vs 39% [42/108]; P =.002). Fewer patients (P =.08) in the octreotide group sustained 1 or more IACs (22% vs 32%). In subgroup analysis, octreotide significantly reduced the rate of patients sustaining 1 or more IACs when the main pancreatic duct diameter was less than 3 mm (P<.02), when pancreatojejunostomy was performed (P<.02), or both (P<.02). No significant differences were found regarding IAC severity. Twenty-three patients (10%) died postoperatively, 16 (70% of deaths) of whom had 1 or more IACs. The only independent risk factor for IACs found on multivariate analysis was pancreatoduodenectomy compared with distal pancreatectomy (P<.01) (odds ratio, 3.54 [95% confidence interval, 1.44-8.65]). CONCLUSIONS: Our results suggest that octreotide is not necessary for all patients undergoing pancreatic resection; it could be useful when the main pancreatic duct is less than 3 mm in diameter and when pancreatoduodenectomy is completed by pancreatojejunostomy.

Adolescent↗
PubMed2003

Risk factors for mortality and morbidity after elective sigmoid resection for diverticulitis: prospective multicenter multivariate analysis of 582 patients.

The prevalence of diverticular disease of the colon is increasing in occidental countries. It would be useful to further decrease the mortality and morbidity after elective sigmoid resection (ESR) for diverticulitis. The aim of this study was to identify modifiable preoperative and intraoperative risk factors for mortality and morbidity after ESR for diverticulitis. A database of 2615 patients who underwent a colon or rectal resection with primary anastomosis between 1985 to 1998 has been constructed from prospective randomized studies published by a French surgical group. Of those patients, 582 had undergone ESR for diverticulitis, and they constitute the population of the present study. A total of 46 potential preoperative and intraoperative risk factors for mortality and morbidity have been studied by univariate and multivariate analysis. The operative mortality for our series was 1.2%, and the overall morbidity was 24.9%. The multivariate analysis revealed two statistically significant independent risk factors of mortality: age >75 (odds-ratio=7.9; 95% confidence interval [CI 1.7-36.6]; p=0.01) and obesity (odds-ratio=5.2; 95% CI [1.1-27.9]; p=0.04). The abdominal morbidity (AM) was 6.5% (38/582). The absence of antimicrobial prophylaxis administration with ceftriaxone was the only significant risk factor for AM in multivariate analysis (p=0.003; odds-ratio=2; 95% CI [1.1-4]). The extraabdominal morbidity (EAM) was 18.4% (107/582). Both chronic pulmonary disease (p=0.008; odds-ratio=2.9; 95% CI [1.4-6]; p=0.008) and cirrhosis (odds-ratio=12; 95% CI [1.2-120]) proved to be significant risk factors for EAM. Weight control prior to surgery, routine administration of prophylactic preoperative antibiotics, and preoperative optimization of the respiratory status of patients with chronic pulmonary disease could decrease the postoperative mortality and morbidity associated with ESR for diverticulitis.

Aged↗
PubMed2003

[Postoperative complications after inguinal hernia repair].

Most complications after inguinal hernia repair are transitory and do not affect the functional outcome. On the other hand, some last longer or become permanent and will be a daily problem for the patient as well as the attending physician. Most prevalent and difficult to treat is pain. Bruising and hematoma are banal and usually resolved spontaneously. Infection can prolong care and promote recurrence. Recurrence seems less frequent after mesh repair, whether by traditional or laparoscopic surgery. Potential complications specific to laparoscopic hernia repair, rare but sometimes severe, must be weighed against the benefits expected by the patient. The patient must be duly informed of the risks and advantages of each technique, whether traditional, laparoscopic, with or without prosthetic material.

Hematoma↗