Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164723
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2005-09-09
Brief Title:
Endoscopic Evaluation of Lower Gastrointestinal Bleeding GIB in Patients Presenting With Melena
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Endoscopic Evaluation of the Incidence and Etiology of Lower Gastrointestinal Bleeding in Patients Presenting With Melena
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the incidence and etiology of small bowel or large bowel bleeding in patients presenting with melena
Detailed Description:
Although tarry stool is a common feature of peptic ulcer bleeding it can also be a manifestation of lower gastrointestinal GI bleeding Examples include colonic cancer small bowel tumors and small or large bowel ulcers induced by aspirin or painkillers NSAIDs However clinicians are often misled by the finding of peptic ulcers as the source of GI bleeding It is not uncommon to detect peptic ulcers incidentally but the source of bleeding is actually in the lower GI tract eg NSAID- or aspirin-induced small or large bowel bleeding ulcers small bowel tumors or colorectal cancer Delay in diagnosis of lower GI bleeding often leads to serious consequences
The preferred investigations for lower GI bleeding are colonoscopy plus video capsule endoscopy Colonoscopy has been the gold standard for the diagnosis of colonic bleeding The risk of colonoscopy-induced complications such as bleeding or perforation is less than 1 in 3500 Video capsule endoscopy is a non-invasive safe and accurate technology that has been approved by the FDA for investigation of small bowel diseases The video capsule is an 11x 26mm capsule that encases a digital camera light-emitting diodes batteries and a transmitter The patient needs to swallow the video capsule after an overnight fast and wear a recording device for eight hours Images are taken twice-per-second and transmitted to the recording device Oral feeding can be resumed after four hours There is no restriction to daily activities The swallowed capsule will be expelled naturally after 5 to 12 hours virtually in all patients The risk of capsule retention is very low and only occurs in patients with severe small bowel stricture
This study aims to assess the incidence and etiology of lower GI bleeding in patients presenting with tarry stool The result will provide important information about the magnitude of the problem of lower GI bleeding that will improve our patient care
The preferred investigations for lower GI bleeding are colonoscopy plus video capsule endoscopy Colonoscopy has been the gold standard for the diagnosis of colonic bleeding The risk of colonoscopy-induced complications such as bleeding or perforation is less than 1 in 3500 Video capsule endoscopy is a non-invasive safe and accurate technology that has been approved by the FDA for investigation of small bowel diseases The video capsule is an 11x 26mm capsule that encases a digital camera light-emitting diodes batteries and a transmitter The patient needs to swallow the video capsule after an overnight fast and wear a recording device for eight hours Images are taken twice-per-second and transmitted to the recording device Oral feeding can be resumed after four hours There is no restriction to daily activities The swallowed capsule will be expelled naturally after 5 to 12 hours virtually in all patients The risk of capsule retention is very low and only occurs in patients with severe small bowel stricture
This study aims to assess the incidence and etiology of lower GI bleeding in patients presenting with tarry stool The result will provide important information about the magnitude of the problem of lower GI bleeding that will improve our patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None