Urgent Colonoscopy for Evaluation and Management of Acute Lower Gastrointestinal Hemorrhage: a Randomized Controlled Trial Bryan T
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American Journal of Gastroenterology ISSN 0002-9270 C 2005 by Am. Coll. of Gastroenterology doi: 10.1111/j.1572-0241.2005.00306.x Published by Blackwell Publishing Urgent Colonoscopy for Evaluation and Management of Acute Lower Gastrointestinal Hemorrhage: A Randomized Controlled Trial Bryan T. Green, M.D., Don C. Rockey, M.D., G. Portwood, M.D., Paul R. Tarnasky, M.D., Steve Guarisco, M.D., Malcolm S. Branch, M.D., Joseph Leung, M.D., and Paul Jowell, M.D. Division of Gastroenterology, Department of Medicine, Duke University Medical Center, Durham, North Carolina OBJECTIVES: We hypothesized that early intervention in patients with lower gastrointestinal bleeding (LGIB) would improve outcomes and therefore conducted a prospective randomized study comparing urgent colonoscopy to standard care. METHODS: Consecutive patients presenting with LGIB without upper or anorectal bleeding sources were randomized to urgent purge preparation followed immediately by colonoscopy or a standard care algorithm based on angiographic intervention and expectant colonoscopy. RESULTS: A total of 50 patients were randomized to each group. A definite source of bleeding was found more often in urgent colonoscopy patients (diverticula, 13; angioectasia, 4; colitis, 4) than in the standard care group (diverticula, 8; colitis, 3) (the odds ratio for the difference among the groups was 2.6; 95% CI 1.1–6.2). In the urgent colonoscopy group, 17 patients received endoscopic therapy; in the standard care group, 10 patients had angiographic hemostasis. There was no difference in outcomes among the two groups—including: mortality 2% versus 4%, hospital stay 5.8 versus 6.6 days, ICU stay 1.8 versus 2.4 days, transfusion requirements 4.2 versus 5 units, early rebleeding 22% versus 30%, surgery 14% versus 12%, or late rebleeding 16% versus 14% (mean follow-up of 62 and 58 months). CONCLUSION: Although urgent colonoscopy identified a definite source of LGIB more often than a standard care algorithm based on angiography and expectant colonoscopy, the approaches are not significantly different with regard to important outcomes. Thus, decisions concerning care for patients with acute LGIB should be based on individual experience and local expertise. (Am J Gastroenterol 2005;100:2395–2402) INTRODUCTION accepted, early endoscopy has not been similarly applied to LGIB. Colonoscopy is often performed after the bleeding has Acute lower gastrointestinal bleeding (LGIB) is a common stopped and the patient adequately prepared, generally several disorder, requiring hospitalization in 21 adults per 100,000/yr days after presentation (3). However, a major problem with (1). Diverticula are the most common cause of acute LGIB colonoscopy in this setting has been the low detection rate of and account for 42–56% of episodes (1–3). Other lesions bleeding lesions, thus not allowing endoscopic hemostasis. It (colonic vascular ectasis, or angiodysplasias, rectal or colonic has been widely reported that urgent colonoscopy is safe and ulcers, colonic varices, vasculitis, neoplasia, colitis, intussus- yields a specific diagnosis in a high proportion of cases (5– ception, or small intestinal lesions) account for the remaining 7). Further, a number of case series have demonstrated that identifiable causes of LGIB. A major problem in LGIB is that endoscopic therapy during urgent colonoscopy allows initial approximately 10–40% of patients will have recurrent hem- hemostasis, especially in diverticular bleeding, although fol- orrhage, usually within the first 48 h of the index bleed (1, low up has been lacking (8–13). Endoscopic therapy of vas- 4). This is often treated by surgical resection. Since the ma- cular ectasis has also been shown to be safe and effective (14, jor causes of acute LGIB (diverticulosis and vascular ectasis) 15). A recent nonrandomized study demonstrated a dramatic are most prevalent in the elderly, surgery often entails a high reduction in rebleeding and the need for surgery with urgent morbidity and mortality. endoscopic therapy in diverticular hemorrhage (7). However, Although early endoscopy for the diagnosis and, in partic- other nonrandomized studies have failed to demonstrate im- ular, treatment of upper gastrointestinal bleeding is widely provement in outcomes after urgent colonoscopy (16, 17). 2395 2396 Green et al. Despite the lack of data from randomized controlled studies, Ongoing bleeding urgent colonoscopy is widely recommended and employed by some experts (7). At our institution, the standard care for Yes No LGIB, after excluding an upper or anorectal source, is to per- Technetium Elective form a technetium labeled red cell scan if active bleeding RBC Scan Colonoscopy is suspected, followed by visceral angiography for positive Positive Negative scans. Expectant colonoscopy is performed if bleeding is felt to be inactive. Visceral Elective We hypothesized that urgent colonoscopy would improve Angiography Colonoscopy early rebleeding and also the secondary outcomes measures of length of stay and transfusion requirements. We present Positive Negative the results of a prospective, randomized, controlled trial of urgent colonoscopy compared to a standard protocol com- monly implemented at this institution in patients with acute Angiographic Elective LGIB. Hemostasis Colonoscopy Elective ME THODS Colonoscopy Figure 1. Standard care algorithm. Technetium RBC scanning was This study was approved by the Duke University Medical performed on patients with suspected active bleeding while those Center and Durham Veterans Affairs Medical Center Insti- without active bleeding had an elective colonoscopy. Patients with a tutional Review Boards, and fulfilled all criteria for clinical positive technetium scan went to visceral angiography while those research as set forth in the Declaration of Helsinki (18). All with a negative scan had an elective colonoscopy. Active bleed- patients gave written informed consent. ing on angiography was treated. All patients receiving angiography (whether positive or negative) had an elective colonoscopy. Patients presenting with hematochezia who were admitted to our hospitals were eligible for the study.Prior to randomiza- tion all patients had upper gastrointestinal sources of bleed- ber of comorbidities were recorded and scored to determine ing excluded by nasogastric lavage and/or esophagogastro- the Charlson comorbidity index (19). The Charlson index duodenoscopy. An upper endoscopy was performed if there is a measure of the number of associated comorbid med- wasnobile present in the gastric lavage fluid, there was a ical conditions that predicts mortality risk at 1 yr. Higher high suspicion of upper gastrointestinal hemorrhage, there scores represent an increased risk of mortality. Patients were wasahistory of peptic ulcer disease, or a history of previous randomized from July 1993 through June 1995. Eligible pa- upper gastrointestinal bleed. Anorectal sources of bleeding tients were randomized to either purge prep colonoscopy or were excluded by anoscopy and/or proctoscopy, one or both the standard care algorithm (defined later) by a computer- of which was performed in all participants. Patients were ran- generated randomization list. All patients were admitted to domized to a standard care algorithm or to purge preparation either the intensive care unit or to telemetry units and man- colonoscopy (Fig. 1). Inclusion criteria were as follows: (1) aged by a team of internists, intensivists, and general sur- the last bloody bowel movement was within 24 h of presen- geons in consultation with gastroenterologists. Investigators tation; (2) there was clinical or laboratory evidence of signif- were not primarily involved in the care or decision making for icant blood loss, manifested by any one of the following: (a) the patients; in some instances, investigators served as con- >3bloody bowel movements in <8h;(b) admission to the sultants to the primary care team. Patients were transferred intensive care unit; (c) decrease of more than 5% hematocrit out of the intensive care unit after hemodynamical stabil- points in <12 h; (d) transfusion of >3 units of packed red ity had been achieved and maintained. Anticoagulants and blood cells; (e) hemodynamic instability in previous 6 h de- nonsteroidal anti-inflammatory drugs (NSAIDs), including fined by: angina, syncope, presyncope, orthostatic vital signs, aspirin, were discontinued during hospitalization in all pa- mean arterial blood pressure <80 mmHg, or resting pulse tients. Packed red blood cells were transfused to correct se- >110. Patients meeting the following criteria were excluded: vere anemia (transfusion threshold—hemoglobin <8 g/dL) (1) age <18 yr; (2) known or suspected inflammatory bowel or to help achieve hemodynamic stability in massive bleed- disease; (3) abdominal surgery within previous 10 days; (4) ing. Coagulopathy was corrected with platelet and/or fresh endoscopic polypectomy within the previous 10 days; (5) frozen plasma transfusion. known or suspected ischemic bowel, perforation, or peritoni- tis; (6) refractory angina or suspected myocardial infarction; Urgent Purge Preparation Colonoscopy (7) hemodynamic instability refractory to resuscitation; (8) Patients randomized to urgent colonoscopy underwent coagulopathy refractory to correction; (9) acquired immune colonic preparation with a polyethelyne glycol based purga- deficiency syndrome or neutropenia; (10) documented preg- tive (Golytely, Braintree Laboratories, Braintree, MA) ad- nancy; (11) inability to provide informed consent.