[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.

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.

[Fast-track rehabilitation for acute cholecystitis: intermediate outcomes of prospective randomized trial]. / Uskorennoe vyzdorovlenie pri ostrom kholetsistite: promezhutochnye rezul'taty prospektivnogo randomizirovannogo issledovaniia.

AIM: To analyze an efficacy of FT-protocol in patients with acute cholecystitis. MATERIAL AND METHODS: Prospective randomized study included 102 patients (45 of main group (FT) and 57 of control groups). Patients did not differ by TG13 severity index. The protocol included information, antibiotic prophylaxis, restriction of drainage, intraperitoneal anesthesia with long-term anesthetics, low pressure pneumoperitoneum, antiemetics in the presence of risk factors, early activation and feeding of the patient. Pain was assessed by VAS immediately after surgery, and 2, 6 and 12-24 hours postoperatively. RESULTS: Surgery time was similar in both groups. Need for anesthesia and pain severity were significantly lower in the FT group. A total absence of pain (VAS 0-1) on the 1st postoperative day was noted in 8 (17.7%) of the FT group and 2 (3.5%) patients of the control group (p=0.038). Shoulder pain developed in 4 (8.9%) cases of the main and 22 (38.6%) cases of the control group (p=0.001). Postoperative nausea developed in 13% of the FT group vs 40.5% in the control group (p=0.05). Hospital-stay was 1.29±0.7 days and 2.7±1.6 (p<0.0001), respectively. The time of the first stool was similar. Twenty-four (53.5%) patients of the FT group and 8,9% of the control group were discharged on 1st postoperative day. There were 2 (IIIA) complications in the main group and 3 - in the control group (IIIA, IIIB and IV). There were no mortality and readmissions. CONCLUSION: FT protocol in AC reduce postoperative pain, dyspepsia, shoulder pain and in-hospital stay with equal number of postoperative complications.

[Comparison of standard and fast track rehabilitation in patients with acute appendicitis. Intermediate results of multicenter prospective randomized trial]. / Sravnitel'naia otsenka metodov standartnoi i uskorennoi reabilitatsii bol'nykh s ostrym appenditsitom. Promezhutochnye rezul'taty mnogotsentrovogo prospektivnogo randomizirovannogo issledovaniia.

AIM: To analyze outcomes of fast track rehabilitation in patients with acute appendicitis. MATERIAL AND METHODS: Prospective, randomized multi-center trial including 86 patients was conducted. There were 38 patients in the main group and 48 in the control group. All patients underwent laparoscopic appendectomy under endotracheal anesthesia. Protocol included informing, no premedication, glucose infusion prior to surgery, antibiotics administration, mesoappendix excision, limited deployment of drainage tubes, intraabdominal prolonged anesthesia, minimal pneumoperitoneum, limited irrigation, minimum power monopolar electrocautery, antiemetics, early activation and eating (2 and 6 hours after surgery). Pain was evaluated by visual-analogue scale. Auscultative peristalsis was considered every 2 hours after surgery. Cortisol level was assessed preoperatively, in 6 and 12-24 hours after surgery in 11 (29%) and 15 (31%) patients of the main and control groups respectively. Discharge criteria: no leukocytosis, fever and pain syndrome requiring anesthesia, no signs of complications and patient's consent. RESULTS: Terms of disease, gender, age and comorbidities were similar in all patients. Duration of surgery under minimal pneumoperitoneum and standard pressure was also similar: 69.2±3.98 and 70.9±3.89 min (p=0.762). Pain syndrome grade and need for analgesics were significantly lower in the main group within entire follow-up. Pain syndrome was absent at the 1st postoperative day in 16 (42%) and 2 (4.1%) patients of both groups, respectively (score 0-1). Phrenic nerve syndrome was observed in 36.8% of the main group and 60.4% of the control group (p=0.05). Incidence of dyspepsia and terms of peristalsis onset were similar. Length of hospital-stay was 1.45 days in the main group and 3.15 days in the control group (p=0.002). In the main group 18 (47%) patients were discharged on the first day after surgery. There were only 4 (8.3%) patients with similar hospital-stay in the control group (p<0.001). There were no repeated hospitalizations. Postoperative cortisol concentration was similar in both groups as well as in complicated and uneventful postoperative period. In the main group postoperative intestinal paresis (Clavien-Dindo grade 2) occurred in 1 patient. In the control group 7 patients had postoperative infiltrate and 1 patient - intestinal paresis (Clavien-Dindo grade 2). Postoperative drainage tube was deployed in 3 out of 7 patients with postoperative infiltrates and 6 of them received antibiotic therapy. Medication was successfully applied in all patients with complications. CONCLUSION: There are some advantages of FTR for AA including reduced pain syndrome, morbidity and less length of hospital-stay. Issue of cortisol concentration requires further trials.

[Optimal time of surgery for acute adhesive small bowel obstruction]. / Vybor sroka operativnogo lecheniia pri ostroi spaechnoi tonkokishechnoi neprokhodimosti (mul'titsentrovoe prospektivnoe randomizirovannoe issledovanie).

AIM: To define optimal terms of surgery for acute adhesive non-strangulatory small bowel obstruction. MATERIAL AND METHODS: The analysis included 703 publications from e-LIBRARI.RU (342 works) and NCBI (361 works) databases for acute adhesive intestinal obstruction. The vast majority of articles presented retrospective analysis of single-center experience. RESULTS: It has been established that short course of medication is predominantly used for acute adhesive intestinal obstruction in the Russian Federation. International studies point 2-5 days for conservative treatment. The advantages and disadvantages of short and long courses of medication were analyzed. Therefore, multicenter, prospective, randomized trial 'Comparison of early operative treatment (12-hour medication) and long-term conservative treatment (48 hours) for acute adhesive small bowel obstruction' (COTACSO) was planned and registered (Unique Protocol ID: 14121729). The study protocol involves clinical, laboratory and instrumental exclusion of strangulation, randomization and conservative treatment of 2 groups of patients for 12 and 48 hours. Patients will undergo surgical interventions if obstruction will be present by that date. The main endpoint is mortality rate in both groups. The end of the study is December 2020.