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Water infusion in lieu of air insufflation during colonoscope insertion

Conventional air insufflation colonoscopy

Water infusion

Air insufflation

Joseph W Leung, MD

Hypothesis

1. Study method achieves lower requirement for medications
2. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
3. Study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy
4. Study method improves bowel preparation and increases polyp pickup rate

Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic VA patients is being promoted (VHA directive). Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy. The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.

Methods that maintain a high success rate and good patient assessment improve overall compliance for surveillance colonoscopy. Our preliminary experience showed that patients are able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was aided by a water infusion in lieu of air insufflation method. In this group of patients, the shortened recovery time means a quick turn around of patient and a more efficient endoscopy service. Patients are able to communicate better with the staff and physician regarding their problem and discharge instructions, and not subjected to the amnesic effect of sedation. Next day follow-up of patient by telephone contact which requires commitment of staff time can be obviated.

If this randomized study confirms the success of our preliminary findings and this technique is adopted by more endoscopists, a larger number of VA patients may benefit from less sedation complications and at the same time allow for more efficient colonoscopy screening services.

Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance

East Bay Institute for Research and Education

Joseph Leung, MD

Symptoms and General Pathology

Colonic Neoplasms

Pain

infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.

infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase

standard colonoscopy using traditional air insufflation during insertion

water immersion

water exchange

air insufflation

Yu-Hsi Hsieh, M.D.

This prospective, randomized controlled trial compares traditional air insufflation with water immersion and water exchange in patients undergoing colonoscopy using on demand sedation. We test the hypothesis that compared with air insufflation the proportion of patients who require on demand sedation during colonoscopy will be significantly lowered by water immersion and water exchange, and water exchange will produce the greatest reduction

The patients will be allocated into 3 groups by computerized randomization. In group A (water exchange), water will be infused and removed at the same time throughout the entire colon during the insertion phase with the air pump turned off. In group B (water immersion), water will be infused in the insertion phase and removed in the withdrawal phase. The water will be used mainly to open the lumen, without attempting to clear the colon contents. In group A and B, warm-to-touch water will be infused mainly infused through the accessory channel of the colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air insufflation not used until the cecum has been reached. . In group C, air insufflation will be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal compression and change of patient position will be utilized at the discretion of the colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be undertaken during the withdrawal phase.

During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none, 10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort. For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter, the nurse will offer sedation, which the patients can accept or decline. If accepted, after an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan, Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an adequate level of sedation. The need of additional drug will be estimated by patient pain response (moans, grimaces and movements). Usually no more propofol will be added during the withdrawal phase. The initial amount of propofol, and those before and after arrival to the cecum will be recorded.

The following parameters will be evaluated and recorded on the patient data sheet: quality of bowel preparation, cecal intubation time, withdrawal time total procedure time, use of abdominal pressure, need for changing position, presence of polyps and reasons for incomplete colonoscopy.

The procedure will be recorded and stored as digital files.

Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation

A Randomized, Controlled Trial Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation

telephone follow up for post-procedure discomforts and 30 days complication rate

Dalin Tzu Chi General Hospital

Chief of department of gastroenterology and hepatology

infuse water during insertion, remove water during withdrawal of colonoscopy

infuse and remove water during insertion phase of colonoscopy

insufflate air during the insertion of colonoscopy

infuse water during insertion, aspirate water during withdrawal

Yu-Hsi Hsieh, Dr.

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).

This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

All procedures will be recorded and stored as digital files.

Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial

telephone follow up for post-procedure discomforts and 30 day complication rate

proportion of patients without insertion pain during colonoscopy

The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)

satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied

the number of participants with at least one adenoma in each of the study groups.

Use air insufflation during colonoscopy

air insufflation: insufflate air during the insertion of colonoscopy

Air Insufflation

infuse water during insertion, remove water during withdrawal of colonoscopy

water immersion: infuse water during insertion, aspirate water during withdrawal

Water Immersion

infuse and remove water during insertion phase of colonoscopy

water exchange: infuse and remove water during insertion phase of colonoscopy

Water Exchange

Total

Age, Continuous

Sex: Female, Male

Dr. Yu-Hsi Hsieh

Use air insufflation during colonoscopy

air insufflation: insufflate air during the insertion of colonoscopy

Proportion of no pain: 30%

infuse water during insertion, remove water during withdrawal of colonoscopy

water immersion: infuse water during insertion, aspirate water during withdrawal

Proportion of no pain: 43.3%

infuse and remove water during insertion phase of colonoscopy

water exchange: infuse and remove water during insertion phase of colonoscopy

Proportion of no pain: 61.1%

Proportion of Patients Without Pain

Patient Pain Score

Patient Satisfaction Score

Number of Participants With at Least One Adenoma

Post-procedure Discomforts and 30 Day Complication Rate

Overall Study

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Air insufflation will be used throughout whole procedure of colonoscopy

Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy.

Water will be infused and removed during insertion phase of colonoscopy

Insufflation during colonoscopy including insertion phase

Water will infused during insertion phase and removed during withdrawal phase of colonoscopy

Water will infused and removed during insertion phase of colonoscopy

Water exchange

Yu-Hsi Hsieh, MD

Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon.

All of the procedures will be recorded and stored as digital files.

Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange

A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy

telephone follow up for post-procedure discomfort and 30 days complication rate

the proportion of patients with the presence of adenoma in the proximal colon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance	NCT00920751	Colorectal Canc...	Water infusion Air insufflatio...	50 Years - 80 Years	East Bay Institute for Research and Education
Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation	NCT01699399	Colon Neoplasm	water immersion water exchange air insufflatio...	20 Years - 80 Years	Dalin Tzu Chi General Hospital
Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy	NCT01535326	Colon Neoplasm Pain	air insufflatio... water immersion water exchange	20 Years - 80 Years	Dalin Tzu Chi General Hospital
Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation	NCT01699399	Colon Neoplasm	water immersion water exchange air insufflatio...	20 Years - 80 Years	Dalin Tzu Chi General Hospital
Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange	NCT01894191	Adenoma	Air insufflatio... water immersion Water exchange	20 Years - 80 Years	Dalin Tzu Chi General Hospital

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