A randomized, multicenter clinical trial was conducted in Western Norway to study the effectiveness of preoperative radiation therapy in operable rectal cancer, given at a dosage of 3150 cGy in 18 fractions, 2 to 3 weeks before radical surgery. Three hundred nine patients were entered into the trial between May 1976 and December 1985. After radiation no tumor was seen in 4.5% of the patients. There was no increased morbidity or mortality at surgery. The 5-year survival for evaluable patients was 57.5% in the control group and 56.7% in the radiotherapy group. For patients operated on for cure the 5-year survival was 60.9% and 64.2% in the control group and radiotherapy group, respectively. Radiation significantly delayed both local and distant recurrences in patients in the radiation group who had curative resection from 13.3 months in controls to 27.1 months. The local recurrence rate in the corresponding groups was 21.1% and 13.7%, respectively. We conclude that higher preoperative radiation doses should be used in new trials as a higher dosage may transform the observed positive effects into a survival benefit.
The purpose of this study was to compare as anti‐infectious prophylaxis in elective colorectal cancer surgery the effect of metronidazole alone and in combination with ampicillin, and the effect of a duration of 1 or 3 days of prophylaxis. The prophylactic regimens designated regimens A‐D given in randomized order were metronidazole 500 mg used alone or with 2.0 g ampicillin administered every 8 hours as separate but simultaneous infusions. All patients studied received preoperative mechanical evacuation of bowel contents. Eight surgical departments participated in the study. Two hundred thirty‐three patients were studied. The distribution of sex, age, and type of operation was similar among the groups of patients receiving each regimen, except that there were more cases of sigmoidectomy, low anterior resection, or rectal amputation in the group receiving regimen D. The duration of the operations was comparable, even for each type of operation considered separately. Samples for bacteriological examination were obtained by abscess punctures when relevant. The pus was taken and transported to the laboratory under anaerobic conditions. Moderate or severe infections were observed in 6 (10.3%) of 58 patients on regimen A, in 2 (3.5%) of 58 patients on regimen B, in 4 (7.0%) of 57 receiving regimen C, and in 2 (3.3%) of 60 given regimen D. The highest incidence of postoperative infections was observed in rectal amputation. The bacteria causing postoperative infections were similar in the regimens A and C receiving only metronidazole for 1 and 3 days, respectively and in regimens B and D in which ampicillin was added. Only one anaerobe, aClostridium perfringens, was recovered from regimen C; twenty‐two strains of anaerobic bacteria were recovered from regimen A. The number of aerobic bacteria was 25 in regimen A and 16 in regimen C. The yield of bacteria was much more sparse when metronidazole was combined with ampicillin. Eleven isolates (2 anaerobes) were recovered from regimen B, only one isolate was recovered from patients on regimen D, an indole positiveProteus. In conclusion, th'is study indicates that a combination of metronidazole and ampicillin is particularly useful in rectal surgery. Metronidazole alone may suffice in colonic surgery, but a combination with an agent against aerobes is recommended in rectal surgery. The difference between 1‐day prophylaxis and 3‐day prophylaxis was insignificant for metronidazole plus ampicillin; a single day of this prophylactic regimen would appear advisable.
A study of 100 patients given short time prophylaxis against anaerobic infections in association with colo-rectal surgery is presented. The patients were randomly allocated into two groups receiving either ornidazole (Tiberal) or doxycycline (Vibramycin) for 3 days. Ornidazole concentrations in serum, subcutaneous fat, and intestinal wall were measured in 10 patients. No infection of anaerobic etiology was noticed in the ornidazole group, in contrast to 5 anaerobic infections in the doxycycline group. This difference is statistically significant (p less than 0.05). The pharmacokinetic results indicate that a 3-day treatment with ornidazole gives a sufficient plasma steady state concentration, while the preoperative loading dose should be given less than 24 h prior to operation. The necessity of prophylaxis against both aerobic and anaerobic infections in colo-rectal surgery is emphasized.
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