Ignite Creation Date:
2025-12-18 @ 8:03 AM
Ignite Modification Date:
2025-12-23 @ 5:48 PM
Study NCT ID:
NCT00747084
Status:
None
Last Update Posted:
2017-04-21 00:00:00
First Post:
2008-09-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Simple and Inexpensive Techniques Enhance Patient Comfort
Sponsor:
None
Organization:
Study Overview
Official Title:
Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation Risk-free Screening and Surveillance Colonoscopy?
Status:
None
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Instruments necessary to continue project have been removed via medical center staff. Therefore, the project cannot continue until they have been replaced.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.
Detailed Description:
None
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?: