Using outcomes data to justify instituting new technology: a single institution's experience.

BACKGROUND: The PILLAR II trial demonstrated PINPOINT is safe, feasible to use with no reported adverse events and resulted in no anastomotic leaks in patients who had a change in surgical plan based on PINPOINT's intraoperative assessment of tissue perfusion during colorectal resection. Whether the cost savings associated with this reduction in anastomotic complications can offset the cost of investing in PINPOINT is unknown. METHODS: We performed a retrospective analysis of all patients (N = 347) undergoing colectomy with primary anastomosis from January 2015 to April 2016. These patients were stratified based on whether fluorescence imaging was used intraoperatively. The clinical outcomes of these patients were then evaluated based on their development of an anastomotic leak or stricture. The direct hospital costs per case were then calculated, and the economic impact of using fluorescence imaging was examined to assess whether decreased direct costs would justify the initial expenditures to purchase new technology (PINPOINT System, NOVADAQ, Canada). RESULTS: Fluorescence imaging in colorectal surgery using PINPOINT reduced the anastomotic failure rate in patients who underwent colon resection. The PINPOINT group (n = 238) had two (0.84%) anastomotic failures, while the non-PINPOINT group (n = 109) had six (5.5%) anastomotic failures. In the PINPOINT group, 11 (4.6%) patients had a change in the resection margin based on the results of the fluorescence imaging, and none of these patients experienced an anastomotic failure. Cost per case was less in the PINPOINT group secondary to fewer direct costs associated with complications. CONCLUSIONS: These results validate the findings of the PILLAR II trial and confirm the decrease in direct costs due to reduction in anastomotic failures as a result of using PINPOINT justified the expense of the new technology after just 143 cases.

Does sodium hyaluronate- and carboxymethylcellulose-based bioresorbable membrane (Seprafilm) decrease operative time for loop ileostomy closure?

BACKGROUND: Adhesions can result in serious clinical complications and make ileostomy closure, which is relatively simple procedure into a complicated and prolonged one. The use of sodium hyaluronate and carboxymethyl cellulose membrane (Seprafilm) was proven to significantly reduce the postoperative adhesions at the site of application. The aim of this study was to assess the incidence and severity of adhesions around a loop ileostomy and to analyze the length of time and morbidity for mobilization at the time of ileostomy closure with and without the use of Seprafilm. METHODS: Twenty-nine surgeons from 15 institutions participated in this multicenter prospective randomized study. 191 patients with loop ileostomy construction were randomly assigned to either receive Seprafilm under the midline incision and around the stoma (Group I), only under the midline incision (Group II), or not to receive Seprafilm (Group III). At ileostomy closure, adhesions were quantified and graded; operative morbidity was also measured. RESULTS: All 3 groups were comparable relative to gender, mean age and number of patients with prior operations (26, 25 and 19, respectively). Group II patients were significantly more likely to have pre-existing adhesions than Group III patients (30.6% vs. 14.1%, p = 0.025). At stoma mobilization, significantly more patients in Group III than in Group I had adhesions around the stoma (95.2% vs. 82.3%, p = 0.021). Mean operative times were 27, 25, and 28 minutes, respectively (p = 0.38), with significant differences among sites. There was no significant difference in the number of patients needing myotomy or enterotomy (29, 27 and 24 patients, respectively), nor in the number of postoperative complications (7, 9 and 7 patients, respectively). CONCLUSIONS: When consistently applied, Seprafilm significantly decreased adhesion formation around the stoma but not operative times without any increase in the need for myotomy or enterotomy. These findings were not seen in the overall study population possibly due to the large number of surgeons using a variety of application techniques.

Treatment of hemorrhagic radiation proctitis with 4 percent formalin.

PURPOSE: The purpose of this study was to review our results in patients undergoing treatment with 4 percent formalin for radiation-induced injury to the rectum. METHODS: A retrospective review of office charts was performed, identifying all patients undergoing formalin treatment. Patient gender, initial malignancy, prior treatments, response to treatment with formalin, complications, and length of follow-up were reviewed. All patients had flexible endoscopy to assess for proximal sources of bleeding. The indication for treatment was a symptomatic patient with endoscopic evidence of radiation injury. A cotton pledget was used for direct application of 4 percent formalin to the affected area via a rigid proctoscope or anoscope. The treatment was repeated if blanching did not occur or if bleeding continued. Patients were followed up at three-week to four-week intervals and treatment was repeated based on the above indications. Treatments were continued until cessation of bleeding occurred or, when treatment failed, operative treatment was required. RESULTS: Thirty-six patients were identified. Three were lost to follow-up. Symptoms included bleeding in all but one patient, who presented with an ulcer. There were 33 (26 male) patients. Seventeen (51.5 percent) patients had prior treatment. The number of formalin treatments ranged from 1 to 13, with a mean of 3.4. The follow-up ranged from 1 to 60 months, with a mean of 18 months. Twenty-nine (88 percent) patients had improvement or cessation of symptoms. Four (12 percent) patients failed treatment. Two patients were noted to have full-thickness ulcers and both failed formalin treatment. No complications were noted related to formalin treatment. CONCLUSION: We conclude that formalin therapy is a safe and effective form of treatment that can be performed in the office with minimal discomfort and no complications. It can be performed multiple times until results are achieved. Formalin therapy may be useful as a first-line treatment for chronic radiation proctitis, however, a prospective controlled trial comparing modalities is required to prove this to be true.

Head injury mechanisms in helmet-protected motorcyclists: prospective multicenter study.

BACKGROUND: In a prospective study, three research groups at Hannover (H) and Munich (M) in Germany and Glasgow (G) in the United Kingdom collected data from motorcycle crashes between July 1996 and July 1998 to investigate head injury mechanisms in helmet-protected motorcyclists. METHODS: The head lesions of motorcyclists with Abbreviated Injury Score-Head (AISHead) 2+ injuries and/or helmet impact were classified into direct force effect (DFE) and indirect force effect (IFE) lesions. The effecting forces and the force consequences were analyzed in detail. RESULTS: Two-hundred twenty-six motorcyclists (H, n = 115; M, n = 56; and G, n = 55) were included. Collision opponents were cars (57.8%), trucks (8.0%), pedestrians (2.3%), bicycles (1.4%), two-wheel motor vehicles (0.8%), and others (4.2%). In 25.4% no other moving object was involved. The mean impact speed was 55 km/h (range, 0-120 km/h) and correlated with AISHead. Seventy-six (33%) motorcyclists had no head injury, 21% (n = 48) AISHead 1, and 46% (n = 103) AISHead 2+. Four hundred nine head lesions were further classified: 36.9% DFE and 63.1% IFE. Lesions included 20.5% bone, 51.3% brain, and 28.1% skin. The most frequent brain lesions were subdural hematomas (22.4%, n = 47) and subarachnoid hematomas (25.2%, n = 53). Lesions of skin or bone were mainly DFE lesions, whereas brain lesions were mostly IFE lesions. CONCLUSION: A modification of the design of the helmet shell may have a preventative effect on DFE lesions, which are caused by a high amount of direct force transfer. Acceleration or deceleration forces induce IFE lesions, particularly rotation, which is an important and underestimated factor. The reduction of the effecting forces and the kinetic consequences should be a goal for future motorcycle helmet generations.

Peer reviewed: the lead fingerprints of gasoline contamination.

Isotopic analysis of the lead additives in gasoline can improve estimates of the ages of leaks and spills.

Motorcycle accidents in Strathclyde Region, Scotland during 1992: a study of the injuries sustained.

The purpose of this study was to describe the pattern and severity of injury, among motorcyclists involved in RTAs, in Strathclyde Region, Scotland, during 1992. This information was required to provide insight into the nature of motorcycle accidents and their consequences, as well as to provide a basis for work on preventive measures. Ninety-six motorcyclist casualties were studied using police and medical information. Their injury information was coded according to AIS 90 and some descriptive statistics applied. Most of the casualties were young and most of them sustained more than one injury. Eight of the casualties died. The legs, arms, head and thorax were the body regions most commonly injured. Serious injury to one or both of the latter two regions, appeared to be implicated in the fatal outcomes. This study confirms that motorcycling is a 'high risk activity', and for those who wish to take that risk, protective measures of optimum standard should be regarded as priority.

Perianal hidradenitis suppurativa.

The management of hidradenitis suppurativa is individualized according to the site and extent of the disease. Initially, short-term antibiotics, local care, and incision and drainage are helpful. Unroofing of sinus tracks, total disease excision, and vigorous physical therapy are more beneficial. Primary or secondary closure or closure by an advancement flap or selective split-thickness skin grafting should be considered in some refractory cases. In most areas, recurrence rates are high unless wide excisions are performed, but perianal hidradenitis can usually be managed more conservatively. Patients with intra-anal disease are better allowed to heal secondarily than by grafting. Split-thickness grafts may contract and lead to anal stenosis, and grafts that are rejected may lead to deep scarring and anal dysfunction. The perianal region is best treated by local excision with secondary closure or by unroofing and curettage when the perianal region is more extensively involved.

Activity of 5-fluorouracil, mitomycin C, and methyl CCNU in inoperable adenocarcinoma of pancreas.

Twenty-two patients with inoperable adenocarcinoma of the pancreas were treated with 5-fluorouracil (5-FU), mitomycin C (Mito-C), and 1(-2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea (MeCCNU). Fifteen were evaluable by completing 2 months of therapy. Two patients achieved a complete remission with the above combination. A partial remission seen in four other patients, which produced a response rate of 40% of evaluable, and 27% of entered, patients. Three had stable disease. The average time to progression in this study was 8 months. This combination was well tolerated and no deaths were secondary to drug therapy. Mucositis, leukopenia, thrombocytopenia, and hyperpigmentation were the significant toxicities seen in this study. These observations are worthy of further investigation.

Locally advanced adenocarcinoma of the breast without distant metastasis treated with multimodal therapies.

Locally advanced breast cancer has been treated with a variety of primary treatments with or without adjuvant therapies. This study combines radiation, chemotherapy, and surgery as a multimodal program for Stage III breast cancer. Radiation was started on day 1: 4600 rad were administered to the breast and 4500 rad were administered to the axilla and supraclavicular areas. Chemotherapy was started on day 1 with weekly intravenous injections of 5-fluorouracil (5FU) (300 mg/m2), methotrexate (15 mg/m2), vincristine (0.625 mg/m2), oral cytoxan (60 mg/m2), and prednisone (30 mg/m2 for two weeks, then 20 mg/m2 for two weeks, then 10 mg/m2 for two weeks). The 5FU, methotrexate, and cytoxan were given for 10 months postsurgery. This combination of modalities produced a complete remission in all 13 patients with Stage III breast cancer after two months of therapy. The median disease-free period was two years. The median survival was 44 months. This approach to the management of Stage III breast cancer is worthy of further investigation.

Nitrate, nitrite balance, and de novo synthesis of nitrate in humans consuming cured meats.

Nitrate balance was measured in nine men consuming a fixed daily diet with constant nitrate (570 mumol/day), varying nitrite (18 to 150 mumol/day), and varying erythorbate levels. Nitrite and erythorbate were added to meat that was then cured and frozen until consumption. All diets were consumed by each subject for 17 days each. Average daily urinary nitrate excretion ranged from 959 to 2382 mumol/day. Subjects excreted significantly more nitrate in urine when fed nitrite cured meats with or without erythorbate than when fed uncured meat (1617 and 1577 versus 1430 mumol nitrate/day, respectively). The amount of nitrate excreted in urine consistently exceeded intakes of nitrate and nitrite by an average 870 mumol/day. This excess represented endogenous synthesis by subjects and was not due to unmeasured nitrate in the diet. The commonly used Greiss and xylenol procedures were unable to measure all nitrate in urine and in diets when compared to high performance liquid chromatographic analyses. The Greiss and xylenol analyses underestimated nitrate synthesis by 220 and 150 mumol/day, respectively when results were not adjusted by determining recovery of added nitrate.

The efficacy of 5-fluorouracil, mitomycin C, and methyl CCNU in advanced colorectal cancer.

Sixty-six patients with advanced colorectal cancer were treated with 5-fluorouracil, Mitomycin C, and 1-(2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea. Fifty-seven patients were evaluable by completing 2 months of therapy. Nine patients (16.0%) achieved a complete remission (CR) with the above combination. A partial remission (PR) was seen in 9 patients. The response rate (CR + PR) was 32%. The average duration of response was 8.5 months. Mucositis, leukopenia, and thrombocytopenia were the significant toxicities experienced in this study.

Hepatic arterial and systemic chemotherapy for the treatment of primary and secondary malignancies of the liver.

Twenty-two patients with metastatic and primary cancer of the liver were treated with 5-fluoro-2'-deoxyuridine (5FUDR), Mitomycin C (Mito C), and 1 (-2-chlorethyl)-4(methyl-cyclohexyl)-1-nitrosourea (MeCCNU). 5FUDR 0.3 mg/kg/day was administered as a continuous infusion via the hepatic artery. Mito C (10 mg/M2) and MeCCNU (50 mg/M2) were given I.V. and orally, respectively, every 8 weeks. Remission of the neoplastic lesions within the liver was seen in 10 patients (4CR, 6PR). Five patients had stabilization of their lesion neoplasm for at least 4 months. The response rate in this study was 6/15 (40%) in patients with colon cancer metastatic to the liver. Toxicity was mainly hematologic and hepatic. Three patients experienced a platelet count below 25,000 and/or white blood count below 1000. Fifteen patients had hepatic toxicity showing elevation in SGOT and SGPT. The SGOT and SGPT returned to normal when the 5FUDR was discontinued. The combination of 5FUDR intraarterially, and Mito C and MeCCNU systemically, demonstrated activity in malignancies of the liver. This study proved that chemotherapy can be administered systemically and regionally with acceptable toxicity.

The efficacy of 5-fluorouracil, mitomycin C, and methyl CCNU in advanced gastrointestinal malignancy.

50 patients with advanced gastrointestinal malignancies were treated with 5-fluorouracil (5FU), 1-(2-chloroethyl)3-(4-methylcyclohexyl)-1-nitrosourea (MeCCNU) and mitomycin C (Mito C). 43 patients, with diagnoses of colorectal, pancreatic or gastric cancer, were evaluable. 13 patients (30%) achieved complete remissions, and 4 achieved partial remissions. The median durations of responses in colorectal, pancreatic and gastric disease were 11.0, 11.0, and 11.5 months, respectively. Survival was definitely prolonged in responding patients with pancreatic and gastric carcinomas. The combination was well tolerated. Mucositis, leukopenia, and thrombocytopenia were the major toxicities that occurred. The quality of life was improved in all responding patients.

Combination chemotherapy in advanced gastrointestinal malignancy.

This study compares two combinations of drugs with proven activity in gastrointestinal malignancy. The drugs utilized are 5-fluorouracil (5FU), mitomycin C (Mito C), and 1-(2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea (MeCCNU). All 57 patients received 5FU 25 mg/kg as a 24-hour infusion for 5 days every 4 weeks. One group received Mito C 20 mg/m2 IV bolus every 8 weeks. The second group received MeCCNU 150 mg/m2 orally every 8 weeks. These combinations are tolerable, and the toxicities are acceptable. The response to 5FU/Mito C is more efficacious at 47% than 5FU/MeCCNU at 25% in the treatment of evaluable patients with colorectal malignancy.

The treatment of ACTH Paraneoplastic syndrome with aminoglutethimide.

A 60-year-old white female with oat-cell carcinoma of the lung presents with a recurrent pulmonary nodule and Cushing syndrome. The tumor is uncontrollable with MeCCNU and cyclophosphamide (Cytoxan), consequently the symptoms of Cushing disease become severe. Cushing syndrome is documented by laboratory examinations. Aminoglutethimide, an anticonvulsant, is used to reverse the symptomatology and also the laboratory values. When aminoglutethimide is discontinued, the laboratory findings return to pretreatment levels.