To examine differences in hospital length of stay (LOS) in patients with acute LGIB receiving either urgent colonoscopy or standard elective colonoscopy.
ID
Source
Brief title
Condition
- Gastrointestinal haemorrhages NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital length of stay (LOS) in days.
Secondary outcome
Blood transfusion requirements, yield of colonoscopy, rebleeding, subsequent
diagnostic or therapeutic interventions related to bleeding, need for
additional diagnostic and/or therapeutic interventions, mortality, morbidity
related to hospital stay and hospital charges
Background summary
The incidence of acute lower gastro-intestinal bleeding (LGIB) is 21 adults per
100.000 person years and is increasing with the ageing of the population. So
far, literature has been inconclusive on the matter of early colonoscopy
(within 24 hours of presentation).
Study objective
To examine differences in hospital length of stay (LOS) in patients with acute
LGIB receiving either urgent colonoscopy or standard elective colonoscopy.
Study design
Non-blinded randomized controlled trail
Intervention
Early colonoscopy versus standard colonoscopy
Study burden and risks
Patients are treated in accordance to the guideline Acute Hematochezia of the
Dutch Society for Gastrointestinal and Liver Diseases (2010). No extra
examinations are required.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42123.098.12 |