BACKGROUND:Patients with adhesive small intestine obstruction (ASIO) are difficult to evaluate and to manage and their treatment is still controversial. The diagnostic and therapeutic role of water-soluble contrast medium (Gastrografin) in ASIO is still debated. This study was designed to determine the therapeutic role of Gastrografin in patients with ASIO. METHODS: The study was a multicenter, prospective, randomized, controlled investigation. The primary end points were the evaluation of the operative rate reduction and shortening the hospital stay after the use of Gastrografin. A total of 76 patients were randomized into two groups: the control group received traditional treatment (TT), whereas the study group (GG) received in addition a Gastrografin meal and follow-through study immediately. Patients with Gastrografin in the colon within 36 hours were considered to be partially obstructed and submitted to nonoperative management. If after 36 hours, the Gastrografin had not entered the colon, the subjects were submitted to laparotomy. RESULTS: No significant differences were found in age, sex, intravenous administration of prokinetics, incidence and characteristics of the previous procedures in surgical history of the patients, previous episodes of ASIO and surgery for adhesiolysis, or duration of symptoms before admission. In the GG group obstruction resolved subsequently in 31 of 38 cases (81.5%) after a mean time of 6.4 hours. The remaining seven patients were submitted to surgery, and one of them needed bowel resection for strangulation. In the control group, 21 patients were not submitted to surgery (55%), whereas 17 showed persistent untreatable obstruction and required laparotomy: 2 of them underwent bowel resection for strangulation. The difference in the operative rate between the two treatment groups reached statistical significance (p = 0.013). The time from the hospital admission for obstruction to resolution of symptoms was significantly lower in the GG group (6.4 vs. 43 hours; p < 0.01). The length of hospital stay revealed a significant reduction in the GG group (4.7 vs. 7.8 days; p < 0.05). This reduction was more evident in the subset of patients who did not require surgery (3 vs. 5.1 days; p < 0.01). No GG-related complications or significant differences in major complications and the relapse rate were found (relapse rate, 34.2% after a mean time to relapse of 6.3 months in the GG group vs. 42.1% after 7.6 months in the TT; p = not significant). CONCLUSIONS: Data showed that the use of Gastrografin in ASIO is safe and reduces the operative rate and the time to resolution of obstruction, as well as the hospital stay.
RCT Entities:
BACKGROUND:Patients with adhesive small intestine obstruction (ASIO) are difficult to evaluate and to manage and their treatment is still controversial. The diagnostic and therapeutic role of water-soluble contrast medium (Gastrografin) in ASIO is still debated. This study was designed to determine the therapeutic role of Gastrografin in patients with ASIO. METHODS: The study was a multicenter, prospective, randomized, controlled investigation. The primary end points were the evaluation of the operative rate reduction and shortening the hospital stay after the use of Gastrografin. A total of 76 patients were randomized into two groups: the control group received traditional treatment (TT), whereas the study group (GG) received in addition a Gastrografin meal and follow-through study immediately. Patients with Gastrografin in the colon within 36 hours were considered to be partially obstructed and submitted to nonoperative management. If after 36 hours, the Gastrografin had not entered the colon, the subjects were submitted to laparotomy. RESULTS: No significant differences were found in age, sex, intravenous administration of prokinetics, incidence and characteristics of the previous procedures in surgical history of the patients, previous episodes of ASIO and surgery for adhesiolysis, or duration of symptoms before admission. In the GG group obstruction resolved subsequently in 31 of 38 cases (81.5%) after a mean time of 6.4 hours. The remaining seven patients were submitted to surgery, and one of them needed bowel resection for strangulation. In the control group, 21 patients were not submitted to surgery (55%), whereas 17 showed persistent untreatable obstruction and required laparotomy: 2 of them underwent bowel resection for strangulation. The difference in the operative rate between the two treatment groups reached statistical significance (p = 0.013). The time from the hospital admission for obstruction to resolution of symptoms was significantly lower in the GG group (6.4 vs. 43 hours; p < 0.01). The length of hospital stay revealed a significant reduction in the GG group (4.7 vs. 7.8 days; p < 0.05). This reduction was more evident in the subset of patients who did not require surgery (3 vs. 5.1 days; p < 0.01). No GG-related complications or significant differences in major complications and the relapse rate were found (relapse rate, 34.2% after a mean time to relapse of 6.3 months in the GG group vs. 42.1% after 7.6 months in the TT; p = not significant). CONCLUSIONS: Data showed that the use of Gastrografin in ASIO is safe and reduces the operative rate and the time to resolution of obstruction, as well as the hospital stay.
Authors: E Feigin; D Seror; A Szold; M Carmon; T M Allweis; A Nissan; E Gross; A Vromen; H R Freund Journal: Am J Surg Date: 1996-02 Impact factor: 2.565