Patient Position and Impact on Colonoscopy Time

NCT00314418 | Completed

• 2 other identifiers: SV0001Digestive Disease
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is usually associated with coiling ("looping") of the colonoscope (instrument used for the procedure) in parts of the bowel. This is the main reason for patient discomfort and lengthens the duration of the procedure. Minimizing the coiling of the colonoscope would decrease the duration, and improve the efficiency and tolerability of the procedure and have a positive impact on colon cancer screening. The primary aim of this study is to compare the time it takes for the colonoscope to reach the end of the colon when the patient is lying on the belly versus the left side (usual) at the start of the procedure. Patients who have medical conditions that may be affected by lying on their belly or those who cannot comfortably lie on the belly will be excluded from the study. Changes in patient position and use of abdominal pressure (commonly given by the endoscopy nurse during the procedure) will be permitted as necessary and determined by the endoscopist. The endoscopist will also retain the decision to discontinue the patient's participation from the study for any medical reason. After the procedure the patient will be monitored in the usual manner and asked to fill out a "satisfaction survey" (24 hours after).

Conditions

Colonoscopy

Keywords

Colonoscopy; technique; time; duration; position; abdominal pressure

Outcome Measures

Primary Outcomes (1)

• Colonoscopic Cecal Intubation time

Secondary Outcomes (1)

• Total colonoscopy time, colonoscope withdrawal time, cumulative sedation dose, recovery time, need for abdominal pressure and changes in patient position during the procedure, adenoma prevalence rate, complications, patient satisfaction.

Interventions

Colonoscopy in the prone position PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Severe Congestive heart failure with left Ventricular ejection fraction \<30%,
• Severe Chronic Obstructive lung disease dependant on Home Oxygen or recent decompensation,
• Spine disease or other condition with difficulty laying in the prone position.

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Shivakumar Vignesh, MD

  VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 13, 2006
• Study Start: September 1, 2005
• Study Completion: March 1, 2006
• Last Updated: April 13, 2006

Record last verified: 2006-04

Locations

US (1)