Michel Scotté1, Francois Mauvais2, Michael Bubenheim3, Cyril Cossé4, Leslie Suaud1, Celine Savoye-Collet5, Isabelle Plenier6, Aurelien Péquignot4, Thierry Yzet7, Jean Marc Regimbeau8. 1. Digestive and Visceral Surgery Department, Rouen University Medical Center, Rouen, France. 2. Digestive and Visceral Surgery Department, Beauvais Hospital, Beauvais, France. 3. Methodological and Biostatistics Unit, Rouen University Hospital, Rouen, France. 4. Digestive and Oncological Surgery Department, Amiens University Medical Center, Amiens, France. 5. Radiology Department, Rouen University Hospital, Rouen, France. 6. Emergency Surgery Department, Lille University Medical Center, Lille, France. 7. Radiology Department, Amiens University Medical Center, Amiens, France. 8. Digestive and Oncological Surgery Department, Amiens University Medical Center, Amiens, France; EA 4292, Jules Verne University of Picardy, Amiens, France; Clinical Research Center, Amiens University Medical Center, Amiens, France. Electronic address: regimbeau.jean-marc@chu-amiens.fr.
Abstract
BACKGROUND: This study evaluated the association between oral gastrografin administration and the need for operative intervention in patients with presumed adhesive small bowel obstruction. METHODS:Between October 2006 and August 2009, 242 patients with uncomplicated acute adhesive small bowel obstruction were included in a randomized, controlled trial (the Adhesive Small Bowel Obstruction Study, NCT00389116) and allocated to a gastrografin arm or a saline solution arm. The primary end point was the need for operative intervention within 48 hours of randomization. The secondary end points were the resection rate, the time interval between the initial computed tomography and operative intervention, the time interval between oral refeeding and discharge, risk factors for the failure of nonoperative management, in-hospital mortality, duration of stay, and recurrence or death after discharge. We performed a systematic review of the literature in order to evaluate the relationship between use of gastrografin as a diagnostic/therapeutic measure, the need for operative intervention, and the duration of stay. RESULTS: In the gastrografin and saline solution arms, the rate of operative intervention was 24% and 20%, respectively, the bowel resection rate was 8% and 4%, the time interval between the initial computed tomography and operative intervention, and the time interval between oral refeeding and discharge were similar in the 2 arms. Only age was identified as a potential risk factor for the failure of nonoperative management. The in-hospital mortality was 2.5%, the duration of stay was 3.8 days for patients in the gastrografin arm and 3.5 days for those in the saline solution arm (P = .19), and the recurrence rate of adhesive small bowel obstruction was 7%. These results and those of 10 published studies suggest that gastrografin did not decrease either the rate of operative intervention (21% in the saline solution arm vs 26% in the gastrografin arm) or the number of days from the initial computed tomography to discharge (3.5 vs 3.5; P = NS for both). CONCLUSION: The results of the present study and those of our systematic review suggest that gastrografin administration is of no benefit in patients with adhesive small bowel obstruction.
RCT Entities:
BACKGROUND: This study evaluated the association between oral gastrografin administration and the need for operative intervention in patients with presumed adhesive small bowel obstruction. METHODS: Between October 2006 and August 2009, 242 patients with uncomplicated acute adhesive small bowel obstruction were included in a randomized, controlled trial (the Adhesive Small Bowel Obstruction Study, NCT00389116) and allocated to a gastrografin arm or a saline solution arm. The primary end point was the need for operative intervention within 48 hours of randomization. The secondary end points were the resection rate, the time interval between the initial computed tomography and operative intervention, the time interval between oral refeeding and discharge, risk factors for the failure of nonoperative management, in-hospital mortality, duration of stay, and recurrence or death after discharge. We performed a systematic review of the literature in order to evaluate the relationship between use of gastrografin as a diagnostic/therapeutic measure, the need for operative intervention, and the duration of stay. RESULTS: In the gastrografin and saline solution arms, the rate of operative intervention was 24% and 20%, respectively, the bowel resection rate was 8% and 4%, the time interval between the initial computed tomography and operative intervention, and the time interval between oral refeeding and discharge were similar in the 2 arms. Only age was identified as a potential risk factor for the failure of nonoperative management. The in-hospital mortality was 2.5%, the duration of stay was 3.8 days for patients in the gastrografin arm and 3.5 days for those in the saline solution arm (P = .19), and the recurrence rate of adhesive small bowel obstruction was 7%. These results and those of 10 published studies suggest that gastrografin did not decrease either the rate of operative intervention (21% in the saline solution arm vs 26% in the gastrografin arm) or the number of days from the initial computed tomography to discharge (3.5 vs 3.5; P = NS for both). CONCLUSION: The results of the present study and those of our systematic review suggest that gastrografin administration is of no benefit in patients with adhesive small bowel obstruction.