Measuring and managing quality of surgery. Statistical vs incidental approaches.

New rules for quality assurance provoked a comparison of effects of two approaches used concurrently for 14 years. In an incidental approach, a multidisciplinary conference reviewed all postoperative complications as they occurred and attributed each to one of six causes. Remedies were instituted and data were filed. In a statistical approach, death and complication rates were computed annually and compared with previous years' rates and with rates reported to Congress as national norms. Statistics suggested acceptable quality in each specialty but calculations were tedious and differences achieved significance too rarely or too slowly to identify problems, protect patients, and improve care. The incidental approach was popular and produced immediate improvements in patient care. Conferees attributed one half of complications to errors. Frequent acknowledgment of susceptibility to error may contribute to the safety and quality shown by our statistics.

Chemotherapy as an adjuvant to surgery for colorectal cancer. A follow-up report.

An adjuvant program of fluorouracil for patients undergoing "curative" resection for adenocarcinoma of the colon and rectum was initiated as a randomized clinical trial in January 1968. Patients were randomly assigned to an intraluminal fluorouracil or intraluminal control (saline) group and were so treated at the time of surgical resection if findings at operation indicated that all gross neoplastic disease could be resected. Those patients receiving intraluminal fluorouracil (30 mg/kg) received intravenous fluorouracil (10 mg/kg) on each of the first two postoperative days and five subsequent postoperative courses of oral fluorouracil (90 mg/kg) in each 18-day course over a one-year period. By July 1, 1975, there were 203 patients undergoing curative resection entered into the study. Survival and disease-free data, as of Dec 31, 1976, revealed no benefit from this adjuvant course of fluorouracil. These data support the need for continued randomized clinical trials of new and innovative adjuvant therapy compared with an untreated control group.

Efficacy of oral and systemic antibiotic prophylaxis in colorectal operations.

A cooperative Veterans Administration study of the septic complication rate during large-bowel surgery was undertaken in two groups of patients. The first group received oral neomycin and erythromycin base plus parenteral placebo; the second, the oral antibiotics plus parenteral cephalothin sodium. During a five-year period, 1,128 patients were studied. The overall septic complication rate was 7.8% in patients receiving only oral antibiotics, and 5.7% in patients receiving both oral and parenteral antibiotics. This difference was not significant. The only significant finding was a greater incidence of fever of unknown origin in patients receiving only oral antibiotics. None of those patients were treated with additional antibiotics, and all fevers cleared spontaneously. There seems to be no discernible benefit from adding parenteral antibiotic prophylaxis when performing elective colon surgery if appropriate mechanical cleansing and oral neomycin and erythromycin therapy are employed.

Surgical management of epidermoid carcinoma of the anus.

An analysis of twenty-six cases of epidermoid carcinoma of the anus from the University of Virginia Medical Center and 1,060 cases from the surgical literature has been presented. We believe this review justifies the following conclusions. (1) Considerable delay in diagnosis frequently occurs, adversely affecting the prognosis of patients with this disease. (2) Abdominoperineal resection remains the treatment of choice. Wide local excision is inadequate for most lesions, and should be reserved for lesions of the anal verge less than 2 cm in diameter with favorable histology, that is, low grade of malignancy. (3) Large lesions and those with a high grade of malignancy are associated with a poor prognosis, but even these patients may sometimes be cured with aggressive surgical excision. (4) Synchronous inguinal node metastases are associated with a poor prognosis, but an occasional patient may be cured by iliofemoral node dissection. (5) Iliofemoral node dissection is indicated for metachronous inguinal node metastases in the absence of distant spread. (6) Iliofemoral node dissection should not be performed if these nodes are not clinically involved with metastases. Approximately 70 per cent of these patients will not need this procedure and would therefore have this resection and its attendant morbidity unnecessarily.

A comparative appraisal of emphysematous cholecystitis.

There is ample evidence from this retrospective comparison to indicate that emphysematous cholecystitis does merit clinical distinction apart from acute cholecystitis. It is an acute infection of the gallbladder caused by a specific group of bacteria that may be aided by some aspect of local ischemia. Cholelithiasis does not seem to be a major factor in the pathogenesis of emphysematous cholecystitis, and this, in association with some dependence upon ischemia, may account for the predominance of this disease in males rather than females. Gangrene is a common feature of the pathologic process, and thus it is not surprising that the diagnosis of emphysematous cholecystitis implies a risk of gallbladder perforation that is five times that expected from ordinary acute cholecystitis. The key to identifying this disease is the plain abdominal roentgenogram which in most instances will make the diagnosis and provide an impetus for early operative intervention.

Treatment of biliary obstruction caused by metastatic cancer.

Over an 8-year period, among 41 patients with obstructive jaundice caused by metastases to the liver or lymph nodes adjacent to the porta hepatis, palliative biliary decompression was established surgically in 11, by percutaneous transhepatic biliary drainage (PTBD) in 25, and by both methods in 2. Three patients had no drainage procedure performed. Early mortality after drainage occurred in 6 of 38 patients, and the median survivals (actuarial) for the remaining 32 patients were 4.5 months for the surgical group (range 2 to 21 months) and 4 months for the PTBD group (range 2 to 14 months). Although there were trends toward more frequent hospital readmissions and episodes of cholangitis in the PTBD group, the only statistically significant difference was in the number of catheter manipulations required. We concluded that when patients develop obstructive jaundice as a manifestation of metastatic cancer, useful palliation can be achieved by either surgical or percutaneous decompression.

Pancreatic and periampullary carcinoma. Experience with 200 patients over a 12 year period.

The operative management of 200 patients with pancreatic and periampullary cancer was reviewed. Patients with metastatic disease and biliary obstruction are best treated by the nonoperative techniques of biopsy and internal biliary drainage if technically feasible. For patients who undergo exploration and are found to be candidates for a bypass procedure, both biliary and gastroduodenal bypass should be performed. Lymph node involvement and age of the patient were found to be significant variables in determining the candidates suitable for curative resection. A definite incidence of multicentricity was found in patients undergoing total pancreatectomy for ductal carcinoma of the pancreas; however, significant problems with diabetic management arose from this procedure. The primary site of the lesion as well as the intelligence and socioeconomic background of the patient should dictate the type of resection employed. Pancreatoduodenectomy (Whipple procedure) is recommended for periampullary cancers other than pancreatic carcinoma, while total pancreatectomy may be appropriate in selected patients. However, there has been no evidence thus far in this early trial with total pancreatectomy that more complete resection of the pancreas leads to longer survival.

Cancer trends: surgical adjuvant therapy for colorectal cancer.

Adequate surgical resection is the most effective primary treatment of potentially curable cancer of the colon and rectum. Radiation therapy, immunotherapy, and chemotherapy are being evaluated in clinical trials to see if they should be recommended for adjuvant therapy.

Emergency operations for gastric and duodenal ulcers in high risk patients.

With routine endoscopy, histamine antagonists, proximal gastric vagotomy (PGV) and declining prevalence of duodenal ulcers, morbidity and mortality of ulcer surgery should have declined. Two hundred thirty-four ulcer operations performed since 1976 were compared with 778 between 1961 and 1971. The hospital mortality rate has increased from 2.7 to 14.5%. Increased mortality was related to a doubling of the rate of emergency operations over age 50 and to a 94% decline in elective operations under 50. Mortality was increased by the need for emergency operations and more by concurrent diseases than by old age. Few operations could have been avoided by earlier elective surgery. Most perforations and hemorrhages occurred from previously unsuspected ulcers, many in patients being treated for other advanced or terminal diseases. Although most deaths occurred in this group, 42% survived. Such patients should be expeditiously offered the definitive operations most appropriate to the locations of their ulcers. Since 1976 among 200 survivors, 20 ulcers have recurred. Most recurred after PGV was tried for pyloric and prepyloric ulcers (8 of 16 recurred) and after previously untreated perforated ulcers were simply closed (4 of 11 recurred). The authors so far have one recurrence after 43 PGVs for duodenal ulcers. These recurrences confirm the need for vagotomy in perforated duodenal ulcer and for resection of ulcers proximal to the duodenum.

The morbidity and mortality of emergent operations for colorectal disease.

p6 participants in the Veterans Administration Cooperative Studies Program investigating antibiotic prophylaxis in colorectal operations, 693 consecutive patients (1978-1981) from three hospitals were studied. This report concerns 20% of these patients who presented with either perforation, obstruction, or hemorrhage necessitating emergent surgical intervention on unprepared bowel. The 30-day, in-hospital mortality of the 138 patients undergoing emergency operations was 28%. Elective colorectal procedures during the same period had a six per cent mortality rate. There is a striking difference in the cause of death in prepared patients and those needing emergent surgery. Death in prepared patients was usually of a vascular etiology, while septic-related mortality was present in only one per cent. On the other hand, despite massive doses of antibiotics, fecal diversion, surgical drainage and lavage, abdominal sepsis was documented in 20% and septic related mortality was present in 17% of patients undergoing emergency operations. Early, elective treatment and prevention of obstruction and perforation will improve our results in colorectal disease.

Carcinoma of the breast in women 35 years of age or younger.

PIP: Between 1921 and 1962, 67 or 4.3% of the women treated at the University of Virginia Medical Center for histologically proven adenocarcinoma of the breast were 35 years of age or under. Of 67 patients, 59 were operable. Bilateral primary adenocarcinomas were present in 9 patients. In 69 radical mastectomies metastases in the ipsilateral axillary nodes were known to be present in 39 patients and absent in 20. 29 women had ovarian ablations, performed surgically in 19 and by radiation in 10; 19 of the 29 had ipsilateral axillary lymph node metastases, 8 had none, and 8 were pregnant or within 1 year postpartum. Postoperative radiation was used in 21 patients with axillary lymph node metastases. The determinate 5-year survival was 15/30 or 50% in women with a radical mastectomy only, and 21/29 or 72% in women with adjuvant ovarian ablation. The 10-year survivals were 9/24 or 38% and 11/18 or 61%, respectively. The survivals compare favorably with the 5- and 10-year determinate survivals without evidence of disease (54% and 42%, respectively) in 448 patients in the entire age spectrum treated at the center in 1956.^ieng

Noninterference of isosulfan blue on estrogen-receptor activity.

Because a 1% sterile solution of methylene blue used for occult breast tumor localization has been shown to interfere with the estrogen-receptor protein (ERP) binding-capacity assay, isosulfan blue in a 1% injection was studied as a potential alternate stain. Cytosols derived from ERP-positive lyophilized powders and human breast tissue were evaluated with and without varying levels of treatment with isosulfan blue. No modification of the ERP-specific binding capacity was found with this stain. The use of isosulfan blue for localization of occult breast tumor is suggested when an ERP binding capacity assay is anticipated.

Effect of methylene blue on estrogen-receptor activity.

Methylene blue in a 1% sterile solution for injection to help localize occult breast tumor was shown to interfere with the estrogen-receptor protein (ERP) binding-capacity assay. Cytosols derived from ERP-positive lyophilized powders and human breast tissue were evaluated with and without varying levels of treatment with methylene blue. Cytosols treated with 0.1% methylene blue, a clinically significant level, demonstrated a substantially lower ERP binding capacity compared with control cytosols. This alteration was found to be due to a reduction in specific binding capacity and not to an alteration in apparent cytosol protein concentration. The use of methylene blue for occult breast tumor localization is not recommended when an ERP binding-capacity assay is anticipated.

Gastrointestinal sarcomas. Analysis of prognostic factors.

Clinical and pathologic data from 51 patients with primary sarcomas of the gastrointestinal tract treated from 1951 through 1984 were reviewed to determine clinical presentation, histologic features, treatment, and prognostic factors. The most common signs and symptoms were abdominal pain (62%), gastrointestinal bleeding (40%), and/or abdominal mass (38%). The primary site was stomach in 50%, small bowel in 30%, colorectum in 15%, and esophagus in 5%. Virtually all the sarcomas were leiomyosarcomas. Distribution was uniform among the three histologic grades; although 88% of Grade 1 tumors could be completely excised, only 35% of Grade 3 tumors could be completely resected. The 5-year survival rate was 75% for Grade 1 tumors, 16% for Grade 2 tumors, and 28% for Grade 3 tumors (p = 0.0013, Grade 1 vs. 2 and 3). Thirty of the 51 patients (59%) had curative resection with an operative morbidity rate of 24% and an operative mortality rate of 12%; at 5 years the disease-free survival rate was 58% and the overall survival rate was 63% (48% at 10 years). Eleven patients (42%) had recurrent disease develop at a median interval of 2 years after complete tumor excision. Twenty-one patients (41%) had partial excision or biopsy only of their tumors with an operative morbidity rate of 28%, operative mortality rate of 8%, and median survival of only 9 months. Overall, patients whose tumors were confined to the site of origin had a 58% 5-year survival rate compared with 20% for those whose tumors had invaded adjacent organs (p less than 0.05). If the tumor was less than 10 cm in size, the 5-year survival rate was 78%, significantly better than the 38% for tumors greater than 10 cm (p = 0.03). These data suggest that histologic grade, local invasiveness, size, and extent of resection are the most important prognostic factors for patients with primary gastrointestinal sarcomas. Patients who have resection of all gross tumor, especially if it is well differentiated and localized, have a good prognosis.