rgent versus elective colonoscopy in acute lower gastrointestinal bleeding: a randomized controlled trial

Completed

Conditions: acute gastro-intestinal bleeding
acute hematochezia
10017959

Registration Number: NL-OMON41384

Lead Sponsor: Medisch Centrum Haaglanden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 132

Inclusion Criteria

All adults aged 18 years or older, presenting with acute hematochezia in the emergency department are included when:
- able to provide written informed consent
- the last bloody bowel movement is within 24 hours of presentation
- an upper gastro-intestinal bleeding source is not suspected or excluded by upper endoscopy;Criteria for suspicion of an upper source are:
- blood urea > 10% of creatinin value
- collapse
- hemodynamic instability (one of the following high risk features present):
* heart rate > 100 beats/min
* systolic blood pressure < 100 mmHg
* orthostatic changes in systolic blood pressure >20 mmHg or in heart rate >20 beats/min
* blood transfusion or drop in haemoglobin >1 mmol/l within a 6 hour period

Exclusion Criteria

Patients are excluded when:
- age < 18 years
- unable to provide written informed consent
- known or suspected acute ischemic bowel, perforation or peritonitis
- hemodynamic instability refractory to resuscitation
- coagulopathy refractory to correction
- documented pregnancy
- serious comorbidities that would preclude to use of colonoscopy in standard clinical practice (i.e. severe COPD, severe cardiovasculair comorbidity)
- decreased level of consiousness

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hospital length of stay (LOS) in days. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Blood transfusion requirements, yield of colonoscopy, rebleeding, subsequent<br /><br>diagnostic or therapeutic interventions related to bleeding, need for<br /><br>additional diagnostic and/or therapeutic interventions, mortality, morbidity<br /><br>related to hospital stay and hospital charges</p><br>