5-Fluorouracil and cisplatin as palliative treatment of advanced oesophageal squamous cell carcinoma. A multicentre randomised controlled trial. The French Associations for Surgical Research.

OBJECTIVE: To compare chemotherapy with no chemotherapy as palliative treatment for oesophageal squamous cell carcinoma. DESIGN: Randomised study. SETTING: Multicentre trial in France. SUBJECTS: Of 161 patients with histologically confirmed oesophageal squamous cell carcinoma located more than 5 cm from the mouth of the oesophagus, five were withdrawn because of protocol violation. The remaining 156 patients, 149 men and 7 women, mean (SD) age 58 (9) years range 36 to 77, were randomly allocated to either a control group without chemotherapy (n = 84) or a group treated by chemotherapy (n = 72). Patients were divided into four strata: I = complete resection of the tumour but with lymph node involvement (n = 62); II = incomplete resection of tumour leaving gross tumour behind (n = 58); III = no resection because of local or regional invasion (n = 22) ; and IV = no resection because of distant metastasis (n = 14). Exclusion criteria were histologically confirmed tracheobronchial involvement, oesophagotracheal fistula, Karnosky score < 50, cerebral metastases, or hepatic metastases occupying more than 30% of the liver, peritoneal carcinomatosis, associated or previously treated ear-nose-throat carcinoma, or complete resection of tumour without lymph node involvement. INTERVENTIONS: 5 fluorouracil (5FU) and cisplatin (CDDP) were given in 5-day courses, once every 28 days, for a maximum of eight cycles. 5 FU, 1 g/m2, was infused for 24 hours after a water overload, during five days. Cisplatin was given either in one dose of 100 mg/m2 at the beginning of the cycle or 20 mg/m2/day over three hours for five days. Duration of treatment ranged from 6-8 months. OUTCOME MEASURES: Median and actuarial survival. The subsidiary endpoint was quality of survival judged by complications of treatment, swallowing disorders, and the duration of ability to feed normally. RESULTS: There was no difference in survival, either overall (median = 12 months) or in any of the strata. There were however significantly more patients with neurological (p < 0.003), haematological (p < 0.0001), and renal (p < 0.0002) complications in the treated group compared with the control group. Four patients (6%) died of complications of chemotherapy. The course of swallowing disorders did not differ between the two groups. The duration of autonomous oral feeding was exactly the same in both groups (median = 10.5 months). CONCLUSION: The results suggest that 5FU and CDDP do not help in patients with squamous cell carcinoma of the oesophagus whether or not the tumour has been resected.

Prophylactic abdominal drainage after elective colonic resection and suprapromontory anastomosis: a multicenter study controlled by randomization. French Associations for Surgical Research.

BACKGROUND: Only 4 controlled trials have investigated whether prophylactic abdominal drainage was of value after colonic resection. None have been able to find any statistically significant difference, but the number of patients was small and the beta error risk was high. OBJECTIVES: To compare patients who underwent abdominal drainage with those who did not for the rate and severity of complications after elective colonic resection followed immediately by anastomosis of the suprapromontory colon and to compare suction drains with nonsuction drains. PATIENTS: Between September 1990 and June 1995, 319 patients (135 men and 184 women), whose mean age was 67 years (range, 22-95 years), with carcinoma, benign tumors, or colitis, located anywhere between the ascending and sigmoid colons, were included in the study. Patients were comparable for demographic characteristics, except that there were more patients with ascites in the group that did not undergo abdominal drainage (P<.02). INTERVENTIONS: After 2 protocol violations, 156 patients were randomized to the abdominal drainage group and 161 to the no abdominal drainage group. All 317 anastomoses were tested for airtightness intraoperatively and repaired if leakage was found (n=71), and all patients with anastomoses received a routine diatrizoate sodium enema to detect infraclinical leakage. MAIN OUTCOME MEASURES: The postoperative complications possibly influenced by drainage included (1) deep complications for which drainage can lead to early diagnosis, such as generalized or localized peritonitis, intraabdominal hemorrhage, or hematoma; (2) complications believed to be enhanced by drainage, such as an operative wound (an abscess, disruption, or incisional hernia) or pulmonary (microatelectasis) and intestinal obstructions; and (3) complications directly due to the drains, such as ulcerations leading to fistulae, hemorrhages, drainage tract infections, difficulty in removal, intra-abdominal retention, and incisional disruptions. Subsidiary end points were the severity of these complications as assessed by the number of related subsequent operations and deaths. RESULTS: Twenty-six patients overall (8%) had postoperative complications possibly influenced by drainage (9% in the group that underwent abdominal drainage and 8% in the group that did not). This difference was not statistically significant (P<.90). One patient had a fistula directly imputable to drainage. There was no difference between suction and nonsuction drainage (P<.90). CONCLUSIONS: Routine abdominal drainage after colonic resection and immediate anastomosis decreases neither the rate nor the severity of anastomotic leakage. It can, occasionally, be detrimental.

[The treatment of abdominal evisceration using the wire technique (author's transl)]. / Traitement des éviscérations par la technique des broches.

The insertion of wires in the preventive and curative treatment of abdominal evisceration is a variety of atraumatic open full-thickness sutures which are easy to carry out and particularly effective. In preventive treatment, they facilitate abdominal closure and avoid the risk of evisceration when large areas of skin are involved. In curative treatment, they form an abdominal "buckle" with the equal distribution of increased pressure over a large area, avoiding pulling on the sutures.