Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial.

BACKGROUND: Acute adhesion-related small bowel obstruction (ASBO) is a common digestive emergency, accounting for 1 to 3% of all digestive emergencies. The efficacy of conservative management in this setting is a subject of debate, as it may delay the decision to perform surgery and increase the frequency of bowel resection (e.g., in the presence of bowel necrosis) or, in contrast, prompt an excessive number of unnecessary laparotomies. Thus, the decision to perform surgery is difficult. We propose that the introduction of the procalcitonin (PCT)-based algorithm improves the quality of the management of patients with ASBO by aiding the decision of whether or not to perform surgery. METHODS: This is a 1:1 cluster-randomized clinical trial (use of algorithm: no algorithm) using an independent computer to ensure that investigators cannot interfere with the randomization. Each cluster will correspond to one investigating center. All patients in a center will be managed in the same way. Before randomization, each principal investigator will provide a commitment to participate in the study to avoid the risk of "empty clusters". The patients included will constitute two parallel arms (use of algorithm versus no algorithm), with no expected crossover between arms. The inclusion criteria are being an adult with uncomplicated acute ASBO (i.e., absence of fever, abdominal pain and distension, nausea and/or vomiting, and the absence of gas and/or stool, in conjunction with a contrast-enhanced CT scan, for patients with previous abdominal surgery) who is able to express consent with a signed written informed consent form. Patients with complicated acute ASBO (strangulation or peritonitis) will be excluded. DISCUSSION: There is an ongoing debate on the management of uncomplicated ASBO. The main points are to avoid a surgery if it is unnecessary and to avoid delayed surgery if it is necessary. Currently, there are no robust criteria to objectively determine the failure of non-surgical treatment or to establish the indications for surgery in acute ASBO. Our team proposes the use of procalcitonin (PCT) to help distinguish patients for whom conservative management is likely to be successful from those for whom surgical management is required. The results from a randomized control trial could help in the selection of patients through clear inclusion and exclusion criteria and simplify or clarify the management algorithm. In conclusion, PCT may be useful in evaluating the proper strategy for ASBO. Trial registration The trial is registered at clinical trials under the reference: NCT03905239.

Incidence, patterns of failure, and prognosis of perforated colorectal cancers in a well-defined population.

INTRODUCTION: Few population-based studies investigate perforated colorectal cancers. This study was designed to compare the epidemiologic characteristics of perforated CRC with those of uncomplicated CRC and to determine patterns of failure and prognosis in a well-defined French population. METHODS: Between 1976 and 2000, 89 patients who received an emergency operation caused by perforation and 5,462 who underwent elective surgery were registered in the digestive cancer registry of Burgundy (France). RESULTS: Perforated colorectal cancers represented 1.6 percent of registered colorectal cancers. The five-year cumulative local recurrence rate was higher for perforated (15.7 percent) than for uncomplicated cancers (7.8 percent; P = 0.021), as well as for the peritoneal carcinomatosis rate (respectively 13.8 and 6.3 percent; P = 0.036). In multivariate analysis, perforation was an independent risk factor for local recurrence or peritoneal carcinomatosis (odds ratio, 2.17; P = 0.004). Operative mortality was higher among perforated cancers (20.2 percent) than after elective surgery (6.6 percent, P < 0.001). The five-year relative survival rates were 37 percent after emergency surgery and 49.2 percent after elective surgery (P = 0.036). After adjustment for sex, stage, and age, perforation remained significantly associated with a poor prognosis. After exclusion of operative mortality, perforation was no more significant. CONCLUSIONS: Perforation is a rare complication of colorectal cancer. The prognosis is poor because of high operative mortality and high risk of local recurrence and peritoneal carcinomatosis.