Howard S. Kaufman

One hundred and forty-five consecutive pancreaticoduodenectomies without mortality.

OBJECTIVE A review of mortality and morbidity for pancreaticoduodenectomy was performed for 145 consecutive patients who underwent the operative procedure between 1988 and 1991. SUMMARY BACKGROUND DATA In the past, pancreaticoduodenectomy has carried a high hospital morbidity and mortality. During the 1970s, many considered that the operation should be abandoned. Recent data, however, suggest that a marked drop in both morbidity and mortality have occurred for this operative procedure. METHODS Among the 145 consecutive patients who underwent pancreaticoduodenectomy, 108 patients were 69 years of age or younger, and 37 were 70 years of age or older. Four patients were 80 years of age or older. One hundred and seven patients had a malignant neoplasm, whereas 38 patients had benign disease. There were no significant differences in preoperative risk factors when the younger and older, and benign disease and malignant disease groups were compared. RESULTS Mean operative time was 7.3 hours. Median blood loss was 0, indicating that more than one-half of the patients underwent pancreaticoduodenectomies without blood transfusions. There were no significant differences in postoperative complications when the younger and older, and benign disease and malignant disease groups were compared. There was no hospital or 30-day mortality. CONCLUSIONS With appropriate preoperative selection, virtually any patient in any age group, with benign or malignant disease, can undergo pancreaticoduodenectomy with minimal risk of hospital mortality.

Chemical Splanchnicectomy in Patients with Unresectable Pancreatic Cancer A Prospective Randomized Trial

OBJECTIVE A prospective, randomized, double-blind study was completed comparing intraoperative chemical splanchnicectomy with 50% alcohol versus a placebo injection of saline in patients with histologically proven unresectable pancreatic cancer. METHODS Standardized assessment of pain, mood, and disability due to pain was completed preoperatively and at 2-month intervals until death. Chemical splanchnicectomy with alcohol was performed in 65 patients, whereas 72 patients received the placebo. The two groups were similar with respect to age, sex, location, and stage of tumor, operation performed, the use of postoperative chemo- and radiation therapy, and initial assessment scores for pain, mood, and disability. RESULTS No differences in hospital mortality or complications, return to oral intake, or length of hospital stay were observed. Mean pain scores were significantly lower in the alcohol group at 2-, 4-, and 6-month follow-up and at the final assessment (p < 0.05). To further determine the effect of chemical splanchnicectomy, patients were stratified into those with and without preoperative pain. In patients without preoperative pain, alcohol significantly reduced pain scores and delayed or prevented the subsequent onset of pain (p < 0.05). In patients with significant preoperative pain, alcohol significantly reduced existing pain (p < 0.05). Furthermore, patients with preexisting pain who received alcohol showed a significant improvement in survival when compared with controls (p < 0.0001). CONCLUSION The results suggest that intraoperative chemical splanchnicectomy with alcohol significantly reduces or prevents pain in patients with unresectable pancreatic cancer.

Hospital Volume Can Serve as a Surrogate for Surgeon Volume for Achieving Excellent Outcomes in Colorectal Resection

OBJECTIVE To examine the association of surgeon and hospital case volumes with the short-term outcomes of in-hospital death, total hospital charges, and length of stay for resection of colorectal carcinoma. METHODS The study design was a cross-sectional analysis of all adult patients who underwent resection for colorectal cancer using Maryland state discharge data from 1992 to 1996. Cases were divided into three groups based on annual surgeon case volume--low (< or =5), medium (5 to 10), and high (>10)--and hospital volume--low (<40), medium (40 to 70), and high (> or =70). Poisson and multiple linear regression analyses were used to identify differences in outcomes among volume groups while adjusting for variations in type of resections performed, cancer stage, patient comorbidities, urgency of admission, and patient demographic variables. RESULTS During the 5-year period, 9739 resections were performed by 812 surgeons at 50 hospitals. The majority of surgeons (81%) and hospitals (58%) were in the low-volume group. The low-volume surgeons operated on 3461 of the 9739 total patients (36%) at an average rate of 1.8 cases per year. Higher surgeon volume was associated with significant improvement in all three outcomes (in-hospital death, length of stay, and cost). Medium-volume surgeons achieved results equivalent to high-volume surgeons when they operated in high- or medium-volume hospitals. CONCLUSIONS A skewed distribution of case volumes by surgeon was found in this study of patients who underwent resection for large bowel cancer in Maryland. The majority of these surgeons performed very few operations for colorectal cancer per year, whereas a minority performed >10 cases per year. Medium-volume surgeons achieved excellent outcomes similar to high-volume surgeons when operating in medium-volume or high-volume hospitals, but not in low-volume hospitals. The results of low-volume surgeons improved with increasing hospital volume but never equaled those of the high-volume surgeons.

Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.

IntroductionAlthough Seprafilm® has been demonstrated to reduce adhesion formation, it is not known whether its usage would translate into a reduction in adhesive small-bowel obstruction.MethodsThis was a prospective, randomized, multicenter, multinational, single-blind, controlled study. This report focuses on those patients who underwent intestinal resection (n = 1,701). Before closure of the abdomen, patients were randomized to receive Seprafilm® or no treatment. Seprafilm® was applied to adhesiogenic tissues throughout the abdomen. The incidence and type of bowel obstruction was compared between the two groups. Time to first adhesive small-bowel obstruction was compared during the course of the study by using survival analysis methods. The mean follow-up time for the occurrence of adhesive small-bowel obstruction was 3.5 years.ResultsThere was no difference between the treatment and control group in overall rate of bowel obstruction. The incidence of adhesive small-bowel obstruction requiring reoperation was significantly lower for Seprafilm® patients compared with no-treatment patients: 1.8 vs. 3.4 percent (P < 0.05). This finding represents an absolute reduction in adhesive small-bowel obstruction requiring reoperation of 1.6 percent and a relative reduction of 47 percent. In addition, a stepwise multivariate analysis indicated that the use of Seprafilm® was the only predictive factor for reducing adhesive small-bowel obstruction requiring reoperation. In both groups, 50 percent of first adhesive small-bowel obstruction episodes occurred within 6 months after the initial surgery with nearly 30 percent occurring within the first 30 days. Additionally no first adhesive small-bowel obstruction events were reported in Years 4 and 5 of follow-up.ConclusionsThe overall bowel obstruction rate was unchanged; however, adhesive small-bowel obstruction requiring reoperation was significantly reduced by the use of Seprafilm®, which was the only factor that predicted this outcome.

Sacral nerve stimulation for fecal incontinence: Results of a 120-patient prospective multicenter study

Background:Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Methods:Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing ≥50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that ≥50% of subjects would achieve therapeutic success, defined as ≥50% reduction of incontinent episodes per week at 12 months compared with baseline. Results:A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2–69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%–90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusion:Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.

Sleeve Gastrectomy in the High-Risk Patient

Background: One of the surgical options available for the super-obese patient is the sleeve gastrectomy. We present results of this operation in a series of 118 patients. Methods: The charts of all patients who have had the sleeve gastrectomy performed were reviewed for demographic data, complications, weight, and nutritional parameters. Results: Median age was 47 years (16-70). Median BMI was 55 kg/m2 (37-108), with 73% of patients having a BMI ≥50 kg/m2. 41% of the patients were male. The operation was performed by laparotomy in all but three cases, which were performed laparoscopically. Median hospital stay was 6 days (3-59). There was one perioperative death (0.85%). 18 patients (15.3%) had postoperative complications. Median percent excess weight loss was 37.8% at 6 months, 49.4% at 12 months, and 47.3% at 24 months. Median follow-up was 13 months (1-66). At 1 year postoperatively, the percentage of patients with normal serum levels of albumin was 100%, hemoglobin 86.1%, and calcium 87.2%, compared to 98.1%, 85.6%, and 94.3% preoperatively. 6 patients requested conversion to a duodenal switch during the follow-up period; all left the hospital in 4-6 days without major complication. Conclusions: Although the sleeve gastrectomy does not result in as much weight loss as the duodenal switch or gastric bypass, it can be used as a stand-alone operation or as a bridge to more complex procedures in the high-risk super-obese patient.

Phase II Evaluation of Preoperative Chemoradiation and Postoperative Adjuvant Chemotherapy for Squamous Cell and Adenocarcinoma of the Esophagus

PURPOSE This phase II trial evaluated continuous-infusion cisplatin and fluorouracil (5-FU) with radiotherapy followed by esophagectomy. The objectives of this trial were to determine the complete pathologic response rate, survival rate, toxicity, pattern of failure, and feasibility of administering adjuvant chemotherapy in patients with resectable cancer of the esophagus treated with preoperative chemoradiation. PATIENTS AND METHODS Patients were staged using computed tomography, endoscopic ultrasound, and laparoscopy. The preoperative treatment plan consisted of continuous intravenous infusion of cisplatin and 5-FU and a total dose of 44 Gy of radiation. Esophagogastrectomy was planned for approximately 4 weeks after the completion of chemoradiotherapy. Paclitaxel and cisplatin were administered as postoperative adjuvant therapy. RESULTS Forty-two patients were enrolled onto the trial. Of the 39 patients who proceeded to surgery, 29 responded to preoperative treatment: 11 achieved pathologic complete response (CR) and 18 achieved a lower posttreatment stage. Five patients had no change in stage, whereas eight had progressive disease (four with distant metastases and four with increases in the T and N stages). At a median follow-up of 30.2 months, the median survival time has not been reached and the 2-year survival rate is 62%. The median survival of pathologic complete responders has not been reached, whereas the 2-year survival rate of this group is 91% compared with 51% in patients with complete tumor resection with residual tumor (P =.03). CONCLUSION An excellent survival rate, comparable to that of our prior preoperative trial, was achieved with lower doses of preoperative cisplatin and 5-FU concurrent with radiotherapy.

Adenocarcinoma of the Duodenum: Factors Influencing Long-Term Survival

This single-institution retrospective analysis reviews the management and outcome of patients with surgically treated adenocarcinoma of the duodenum. Between February 1984 and August 1996, fifty-five patients with adenocarcinoma of the duodenum underwent surgery at The Johns Hopkins Hospital. Univariate analysis was performed to identify possible prognostic indicators. Curative resection was performed in 48 patients (87%): 35 of these patients (73%) underwent a pancreaticoduodenectomy (PD), whereas 27% (n = 13) underwent a pancreas-sparing duodenectomy (PSD). Patients undergoing PD were comparable to those undergoing PSD with respect to demographic factors, presenting symptoms, and tumor pathology. The remaining 13% of patients (n = 7) were deemed unresectable at the time of surgery and underwent biopsy and/or palliative bypass. PD was associated with an increase in postoperative complications when compared to PSD (57% vs. 30%), but this difference was not statistically significant. One perioperative death occurred following PD (mortality 2.9%), The overall 5-year survival rate for the 48 patients undergoing potentially curative resection was 53 %. Negative resection margins (P <0.001), PD (P <0.005), and tumors in the first and second portions of the duodenum (P <0.05) were favorable predictors of long-term survival by univariate analysis. Nodal status, tumor diameter, degree of differentiation, and the use of adjuvant chemoradiation therapy did not influence survival. These data support an aggressive role for resection in patients with adenocarcinoma of the duodenum

Dynamic pelvic magnetic resonance imaging and cystocolpoproctography alter surgical management of pelvic floor disorders

PURPOSE: Pelvic organ prolapse results in a spectrum of progressively disabling disorders. Despite attempts to standardize the clinical examination, a variety of imaging techniques are used. The purpose of this study was to evaluate dynamic pelvic magnetic resonance imaging and dynamic cystocolpoproctography in the surgical management of females with complex pelvic floor disorders. METHODS: Twenty-two patients were identified from The Johns Hopkins Pelvic Floor Disorders Center database who had symptoms of complex pelvic organ prolapse and underwent dynamic magnetic resonance, dynamic cystocolpoproctography, and subsequent multidisciplinary review and operative repair. RESULTS: The mean age of the study group was 58 ± 13 years, and all patients were Caucasian. Constipation (95.5 percent), urinary incontinence (77.3 percent), complaints of incomplete fecal evacuation (59.1 percent), and bulging vaginal tissues (54.4 percent) were the most common complaints on presentation. All patients had multiple complaints with a median number of 4 symptoms (range, 2–8). Physical examination, dynamic magnetic resonance imaging, and dynamic cystocolpoproctography were concordant for rectocele, enterocele, cystocele, and perineal descent in only 41 percent of patients. Dynamic imaging lead to changes in the initial operative plan in 41 percent of patients. Dynamic magnetic resonance was the only modality that identified levator ani hernias. Dynamic cystocolpoproctography identified sigmoidoceles and internal rectal prolapse more often than physical examination or dynamic magnetic resonance. CONCLUSIONS: Levator ani hernias are often missed by physical examination and traditional fluoroscopic imaging. Dynamic magnetic resonance and cystocolpoproctography are complementary studies to the physical examination that may alter the surgical management of females with complex pelvic floor disorders.

Cytomegaloviral enterocolitis: clinical associations and outcome.

PURPOSE: Cytomegaloviral enterocolitis is an uncommon disorder that can complicate inflammatory bowel disease. It is more common in patients with acquired immunodeficiency syndrome and can occur in patients on immunosuppressive therapy for autoimmune or inflammatory diseases and in allograft recipients. Mortality rates of up to 71 percent have been reported for cytomegaloviral enterocolitis. The aims of this study were 1) to identify the presentation, underlying medical conditions, treatment, and outcome of patients with cytomegaloviral enterocolitis and 2) to determine the prevalence of this infection in patients undergoing intestinal resection for inflammatory bowel disease. METHODS: A retrospective chart review of patients with pathologic evidence of cytomegaloviral enterocolitis from 1985 through 1996 was performed. To determine the prevalence of this condition, the hospital discharge database was searched for the diagnoses of ulcerative colitis and Crohns disease in patients who underwent bowel resection. RESULTS: 93 patients (mean age, 44 years; 66 percent males) had cytomegaloviral infection in the small intestine (n=6), large intestine (n=86), or appendix (n=1). Patients with acquired immunodeficiency syndrome (n=42), with ulcerative colitis (n=11), with Crohns disease (n=11), receiving organ transplant (n=12), receiving bone marrow transplant (n=8), and in other immunosuppressed states (n=11) comprised this study. Seventeen patients (18 percent) underwent intestinal resection, and the remaining 76 patients were treated medically. Abdominal pain (77vs. 37 percent;P<0.01) and gastrointestinal bleeding (65vs. 34 percent;P<0.05) were more common presenting symptoms in patients who required resection than patients in the medically managed group. Mortality was 17.6 percent in the surgically managed group and 14.5 percent in the patients who were managed medically. The median duration of ulcerative colitis in patients with coexisting cytomegaloviral infection was 12 months. The prevalence of cytomegaloviral enterocolitis was 4.6 percent in patients with ulcerative colitis and 0.8 percent in patients with Crohns disease. CONCLUSIONS: These data suggest that cytomegaloviral infection more frequently complicates ulcerative colitis than Crohns disease. Furthermore, a short and fulminant course of ulcerative colitis may indicate coexisting cytomegaloviral infection. The overall low mortality in this retrospective study suggests that aggressive medical and surgical treatment improves survival in patients with cytomegaloviral enterocolitis.