[Comparison of early operative treatment and 48-hour conservative treatment in small bowel obstruction (COTACSO): intermediate results]. / Promezhutochnye rezul'taty otkrytogo prospektivnogo randomizirovannogo mnogotsentrovogo sravnitel'nogo issledovaniya rannei operatsii i 48-chasovogo neoperativnogo lecheniya spaechnoi kishechnoi neprokhodimosti.

ABSTRACT

Optimal treatment for adhesive small bowel obstruction (SBO) is not defined. Surgery is the only method of treatment for obvious strangulating SBO. Non-operative management (NOM) is widely used among patients with low risk of strangulation, i.e. no clinical, laboratory and CT signs. Randomized controlled trials (RCTs) are recommended to determine the optimal method (early intervention or NOM), but their safety is unclear due to possible delay in surgery for patients needing early intervention. MATERIAL AND METHODS: A RCT is devoted to outcomes of early operative treatment and NOM for adhesive SBO. The estimated trial capacity is 200 patients. Thirty-two patients were included in interim analysis. In 12 hours after admission, patients without apparent signs of strangulation were randomized into two clinical groups after conservative treatment. Group I included 12 patients who underwent immediate surgery, group II - 20 patients after 48-hour NOM. The primary endpoint was success of non-surgical regression of SBO and reduction in mortality. To evaluate patient safety, we analyzed mortality, complication rates and bowel resection in this RCT with previously published studies. RESULTS: In group I, all 12 (100%) patients underwent surgery. Only 4 (20%) patients required surgery in group II. Mortality, complication rates and bowel resection rates were similar in both groups. Strangulating SBO was found in 8 (25%) patients. Overall mortality was 6.3%, bowel resection rate - 6.3%, iatrogenic perforation occurred in 3 (18.8%) patients. These values did not exceed previous findings. CONCLUSION: Non-operative management within 48 hours prevented surgery in 80% of patients with SBO. Interim analysis found no significant between-group differences in mortality, complication rates and bowel resection rate. Patients had not been exposed to greater danger than other patients with adhesive SBO. The study is ongoing.