Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314418
Status:
COMPLETED
Last Update Posted:
2006-04-13
First Post:
2006-04-11
Brief Title:
Patient Position and Impact on Colonoscopy Time
Sponsor:
VA Connecticut Healthcare System
Organization:
VA Connecticut Healthcare System
Study Overview
Official Title:
Patient Position and Impact on Colonoscopic Cecal Intubation Time
Status:
COMPLETED
Status Verified Date:
2006-04
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:
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 patients 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
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 patients 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
Detailed Description:
1 Principal investigator Shivakumar Vignesh MD Gastroenterology Attending Physician VACHS
Colonoscopy with the patient in the prone position may reduce colonoscopy duration and may reduce patient discomfort by a reduction in coiling of the colonoscope with a mobile part of the bowel decreased need for abdominal pressure and less sedation may improve the safety and efficacy of colonoscopy
Objective To determine if starting colonoscopy with the patient in the prone position will reduce cecal intubation time time to reach the cecum and total sedation requirement
Subjects 120 adult male patients referred of outpatient colonoscopy will be the study subjects and controls We do 15-18 colonoscopies a day and assuming half that number meet criteria for inclusion and consent to the study we will be able to recruit 120 patients in 6 months or less Our records indicate more than 1000 colonoscopies are performed in a six-month period If we conservatively estimate 10 ineligible patients n900 remaining 50 refusal n450 remaining and enrollment on 4 of 5 weekdays n360 remaining the six-month period would provide adequate sample size The study would end if the target sample size is reached early
Inclusion criteria All adult male patients presenting for outpatient colonoscopy Patients who have had colonoscopies in the past and those who present for their first colonoscopy will be invited to participate in the study It will not matter if it is their first or repeat colonoscopy as they will be randomized to either position
Exclusion criteria Severe obstructive lung disease requiring home oxygen congestive heart failure not adequately managed other conditions causing breathing difficulty massive ascites fluid accumulation causing a tensely distended abdomen or inability to lie prone for any reason Patients allergic to Versed or Fentanyl will be excluded from the study
All female patients will be excluded as they comprise less than 2 of our colonoscopies and we dont routinely check if female patients are pregnant and the safety of lying prone during colonoscopy in pregnancy is unknown
No vulnerable populations will be included
Selection At the time of presentation for outpatient colonoscopy patients satisfying the inclusion and exclusion criteria will be educated about the purpose risks and benefits of the study and informed consent will be obtained
Participants will be randomized using a permuted block scheme with equal allocation among treatment arms Treatment will be initiated immediately following random assignment
The statistician will release the randomization scheme and assignments to Karl Larson PA not involved in the study who will inform the PI of the study assignment after patients are consented prior to the colonoscopy
Recruitment For our single center VACHS study we plan to enroll a total of 120 patients among the patients presenting for outpatient colonoscopy 60 in each arm DrVignesh PI will select patients by applying the inclusion and exclusion criteria review their VA medical record take a history and a physical done before every colonoscopy and at the same time will obtain the consent for both the colonoscopy and the study They will be randomized using a permuted block randomization scheme and allocation concealed till the start of procedure
Research Plan Single-center VACHS Prospective randomized controlled non-blinded The GI fellow doing the data analysis will be blinded to the assignment study of positioning for colonoscopy in veterans undergoing outpatient colonoscopy
Basis of sample size calculation The national average time for cecal intubation is 15 minutes A reduction in the colonoscopy duration by 3 minutes would be clinically meaningful and reduce cost We do 15-20 outpatient colonoscopies in two rooms with one nurse per room daily at the West Haven VA and a reduction of 3 minutes per colonoscopy will save 45-60 minutes per day and this does not include the potential reduction in recovery time from using less sedation
Sample size calculations using nQuery Advisor assuming 15 minutes for a standard procedure and 12 minutes for a prone procedure common standard deviation of 5 minutes the difference in duration of 2 minutes has important public health implications and was considered clinically meaningful in other studies of modifications in Colonoscopy procedures 456789 Using a two-tail alpha error of 005 and beta error of 010 power 90 60 patients in each arm would be required 120 total The study would end if the target sample size is reached early
Methodology
The bowel preparation type of colonoscopes techniques including polypectomy will be the same as our routine practice they are mentioned below to be complete
All patients who undergo outpatient colonoscopy at our institution receive the following as bowel preparation
1 Clear liquid diet 24 hours prior to procedure
2 One gallon of Golytely the day prior to colonoscopy starting at noon
3 Patients with serum creatinine under 20 to drink 300 cc of magnesium citrate following the Golytely
Standard adult colonoscopes only will be used Polyps will be removed with snare polypectomy or biopsy upon withdrawal of the colonoscope from the cecum as is the normal practice In the event of failure to reach the cecum with the standard adult colonoscope a variable-stiffness colonoscope adult or pediatric will be used 4 6 In patients with severe stenosing diverticular disease with difficulty in navigating the affected segment a pediatric variable stiffness colonoscope will be used 5
Midazolam and Fentanyl will be the only medications used their doses depending on the patients vital signs and discomfort
Vital signs will be monitored every 5 minutes during the procedure All patients will be placed on oxygen 2 liters via nasal cannula prior to commencement of colonoscopy
After starting the procedure changes in patients position or abdominal pressure will be documented
Baseline data and demographic information including height weight age co-morbid illnesses and history of abdominal surgery will be collected from each patient to enable comparison between the two arms
After starting the procedure if the patients position is altered or abdominal pressure is used to help with the colonoscopy it will be documented as position change and abdominal pressure but there will be no crossover Our study is not powered to measure differences between position changes or abdominal pressure these will merely be described The patients whose position is altered will be analyzed based on the original group assignment Intent to treat analysis
Complications of colonoscopy being rare Bleeding 1 and perforation 002 will be described if they occur but our study is not powered to analyze them
Primary Endpoint
1 Time to cecal intubation
Secondary Endpoint
1 Total medication Midazolam and Fentanyl dose dichotomized to low Midazolam 4mg IV or less Fentanyl 200 mcg IV or less or high Midazolam 4 mg IV and Fentanyl 200 mcg IV
The time to cecal intubation will be measured and a t-test will be used to compare the difference between the mean duration
The total opiate doses will be recorded and dichotomized to low Midazolam 4mg IV or less Fentanyl 200 mcg IV or less or high Midazolam 4 mg IV and Fentanyl 200 mcg IV compared using the Chi-square test
The prone position lying on the belly does not increase risk of complications based on our experience We have done hundreds of colonoscopies safely in the prone position The prone position with the patients head turned to one side may reduce aspiration risk as it facilitates the drainage of secretions via the mouth By applying our exclusion criteria we do not offer the study to a patient with a medical condition that is affected by lying on the belly
Colonoscopies are done with conscious sedation last 30 minutes and have the same stringent cardio respiratory monitoring For this study we will follow our standard continuous cardio-respiratory monitoring blood pressure measurements every 5 minutes We also administer Oxygen 2 liters by nasal cannula routinely We have an adverse event form to document any cases of cardio-respiratory depression or any other adverse event in a procedure involving conscious sedation The physicians involved in conscious sedation have been certified in a Conscious sedation and airway management course conducted by Yale New Haven hospital
Informed Consent will be obtained for the colonoscopy outlining the risks and separately for study using the VA research consent form The consents will be obtained in the ambulatory procedure unit after the patients are prepared for the colonoscopy
We strictly adhere to HIPAA regulations in our daily practice The information obtained in the study and the patients medical record will be de-identified and accessible to the investigators mentioned above exclusively
Your research records will be kept as confidential as possible and only the gastroenterologists and the endoscopy nurses participating in your case will have access to the information obtained for the study Only a code number will identify your research records The code number will not be based on any information that could be used to identify you The master list linking names to code numbers will be kept separately from the research data All research information will be kept in locked files at all times Only authorized research staff will have access to the information gathered in this study A note describing your participation in this research study will be placed in your VA medical record
Colonoscopy with the patient in the prone position may reduce colonoscopy duration and may reduce patient discomfort by a reduction in coiling of the colonoscope with a mobile part of the bowel decreased need for abdominal pressure and less sedation may improve the safety and efficacy of colonoscopy
Objective To determine if starting colonoscopy with the patient in the prone position will reduce cecal intubation time time to reach the cecum and total sedation requirement
Subjects 120 adult male patients referred of outpatient colonoscopy will be the study subjects and controls We do 15-18 colonoscopies a day and assuming half that number meet criteria for inclusion and consent to the study we will be able to recruit 120 patients in 6 months or less Our records indicate more than 1000 colonoscopies are performed in a six-month period If we conservatively estimate 10 ineligible patients n900 remaining 50 refusal n450 remaining and enrollment on 4 of 5 weekdays n360 remaining the six-month period would provide adequate sample size The study would end if the target sample size is reached early
Inclusion criteria All adult male patients presenting for outpatient colonoscopy Patients who have had colonoscopies in the past and those who present for their first colonoscopy will be invited to participate in the study It will not matter if it is their first or repeat colonoscopy as they will be randomized to either position
Exclusion criteria Severe obstructive lung disease requiring home oxygen congestive heart failure not adequately managed other conditions causing breathing difficulty massive ascites fluid accumulation causing a tensely distended abdomen or inability to lie prone for any reason Patients allergic to Versed or Fentanyl will be excluded from the study
All female patients will be excluded as they comprise less than 2 of our colonoscopies and we dont routinely check if female patients are pregnant and the safety of lying prone during colonoscopy in pregnancy is unknown
No vulnerable populations will be included
Selection At the time of presentation for outpatient colonoscopy patients satisfying the inclusion and exclusion criteria will be educated about the purpose risks and benefits of the study and informed consent will be obtained
Participants will be randomized using a permuted block scheme with equal allocation among treatment arms Treatment will be initiated immediately following random assignment
The statistician will release the randomization scheme and assignments to Karl Larson PA not involved in the study who will inform the PI of the study assignment after patients are consented prior to the colonoscopy
Recruitment For our single center VACHS study we plan to enroll a total of 120 patients among the patients presenting for outpatient colonoscopy 60 in each arm DrVignesh PI will select patients by applying the inclusion and exclusion criteria review their VA medical record take a history and a physical done before every colonoscopy and at the same time will obtain the consent for both the colonoscopy and the study They will be randomized using a permuted block randomization scheme and allocation concealed till the start of procedure
Research Plan Single-center VACHS Prospective randomized controlled non-blinded The GI fellow doing the data analysis will be blinded to the assignment study of positioning for colonoscopy in veterans undergoing outpatient colonoscopy
Basis of sample size calculation The national average time for cecal intubation is 15 minutes A reduction in the colonoscopy duration by 3 minutes would be clinically meaningful and reduce cost We do 15-20 outpatient colonoscopies in two rooms with one nurse per room daily at the West Haven VA and a reduction of 3 minutes per colonoscopy will save 45-60 minutes per day and this does not include the potential reduction in recovery time from using less sedation
Sample size calculations using nQuery Advisor assuming 15 minutes for a standard procedure and 12 minutes for a prone procedure common standard deviation of 5 minutes the difference in duration of 2 minutes has important public health implications and was considered clinically meaningful in other studies of modifications in Colonoscopy procedures 456789 Using a two-tail alpha error of 005 and beta error of 010 power 90 60 patients in each arm would be required 120 total The study would end if the target sample size is reached early
Methodology
The bowel preparation type of colonoscopes techniques including polypectomy will be the same as our routine practice they are mentioned below to be complete
All patients who undergo outpatient colonoscopy at our institution receive the following as bowel preparation
1 Clear liquid diet 24 hours prior to procedure
2 One gallon of Golytely the day prior to colonoscopy starting at noon
3 Patients with serum creatinine under 20 to drink 300 cc of magnesium citrate following the Golytely
Standard adult colonoscopes only will be used Polyps will be removed with snare polypectomy or biopsy upon withdrawal of the colonoscope from the cecum as is the normal practice In the event of failure to reach the cecum with the standard adult colonoscope a variable-stiffness colonoscope adult or pediatric will be used 4 6 In patients with severe stenosing diverticular disease with difficulty in navigating the affected segment a pediatric variable stiffness colonoscope will be used 5
Midazolam and Fentanyl will be the only medications used their doses depending on the patients vital signs and discomfort
Vital signs will be monitored every 5 minutes during the procedure All patients will be placed on oxygen 2 liters via nasal cannula prior to commencement of colonoscopy
After starting the procedure changes in patients position or abdominal pressure will be documented
Baseline data and demographic information including height weight age co-morbid illnesses and history of abdominal surgery will be collected from each patient to enable comparison between the two arms
After starting the procedure if the patients position is altered or abdominal pressure is used to help with the colonoscopy it will be documented as position change and abdominal pressure but there will be no crossover Our study is not powered to measure differences between position changes or abdominal pressure these will merely be described The patients whose position is altered will be analyzed based on the original group assignment Intent to treat analysis
Complications of colonoscopy being rare Bleeding 1 and perforation 002 will be described if they occur but our study is not powered to analyze them
Primary Endpoint
1 Time to cecal intubation
Secondary Endpoint
1 Total medication Midazolam and Fentanyl dose dichotomized to low Midazolam 4mg IV or less Fentanyl 200 mcg IV or less or high Midazolam 4 mg IV and Fentanyl 200 mcg IV
The time to cecal intubation will be measured and a t-test will be used to compare the difference between the mean duration
The total opiate doses will be recorded and dichotomized to low Midazolam 4mg IV or less Fentanyl 200 mcg IV or less or high Midazolam 4 mg IV and Fentanyl 200 mcg IV compared using the Chi-square test
The prone position lying on the belly does not increase risk of complications based on our experience We have done hundreds of colonoscopies safely in the prone position The prone position with the patients head turned to one side may reduce aspiration risk as it facilitates the drainage of secretions via the mouth By applying our exclusion criteria we do not offer the study to a patient with a medical condition that is affected by lying on the belly
Colonoscopies are done with conscious sedation last 30 minutes and have the same stringent cardio respiratory monitoring For this study we will follow our standard continuous cardio-respiratory monitoring blood pressure measurements every 5 minutes We also administer Oxygen 2 liters by nasal cannula routinely We have an adverse event form to document any cases of cardio-respiratory depression or any other adverse event in a procedure involving conscious sedation The physicians involved in conscious sedation have been certified in a Conscious sedation and airway management course conducted by Yale New Haven hospital
Informed Consent will be obtained for the colonoscopy outlining the risks and separately for study using the VA research consent form The consents will be obtained in the ambulatory procedure unit after the patients are prepared for the colonoscopy
We strictly adhere to HIPAA regulations in our daily practice The information obtained in the study and the patients medical record will be de-identified and accessible to the investigators mentioned above exclusively
Your research records will be kept as confidential as possible and only the gastroenterologists and the endoscopy nurses participating in your case will have access to the information obtained for the study Only a code number will identify your research records The code number will not be based on any information that could be used to identify you The master list linking names to code numbers will be kept separately from the research data All research information will be kept in locked files at all times Only authorized research staff will have access to the information gathered in this study A note describing your participation in this research study will be placed in your VA medical record
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Digestive Disease | None | None | None |