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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

Polyps

Rectal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

Colonoscopy performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.

Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if \>3) if the lumen cannot be seen. Withdrawal phase done using air insufflation.

Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using air insufflation.

Air insufflation method.

Water Immersion during insertion, air insufflation during withdrawal.

Water Immersion method.

Water Exchange during insertion, air insufflation during withdrawal.

Water Exchange method.

Sergio Cadoni, MD

The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer.

Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was \>9 mm, P\<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy.

Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy.

In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for \<10 mm adenomas in the proximal colon.

In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy.

We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly \<10 mm adenomas, thus increasing proximal colon ADR and proximal colon ADR \<10 mm. Confirmation of secondary hypotheses will provide justification for further testing that WE may provide a strategy to improve prevention of colorectal cancer by increasing detection of adenomas in screening colonoscopy.

Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases of colonoscopy will be done by different investigators. The second investigator will be blinded to the method used to insert the instrument, thus eliminating possible bias about procedure related issues.

Several secondary outcomes will also be analysed.

Design: Prospective double-blinded multicenter randomized controlled trial. Methods: Colonoscopy with Air Insufflation, Water Immersion, Water Exchange to aid insertion of colonoscope; split dose bowel preparation. Sedation available at the start of the procedure or on-demand.

Control method: Air insufflation colonoscopy. Study methods: Water Immersion colonoscopy, Water Exchange colonoscopy.

Population: Consecutive 50 to 70 year-old screening patients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.

Primary outcome: overall Adenoma Detection Rate. Secondary outcomes: proximal colon ADR, Mean Adenomas resected per Procedure (MAP), cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), maximum pain during colonoscopy assessed during insertion and at discharge, the need for sedation/analgesia and its dosage. In addition loop reduction maneuvers, position changes, abdominal compression, the amount of infused and suctioned water during insertion and withdrawal, and patients willingness to repeat the examination will be evaluated.

Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening

A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange for Adenoma Detection Rate in Screening Colonoscopy

Applied as needed if advancement of the colonoscope fails.

Change in patient position as needed if advancement of the colonoscope fails.

Compression of abdomen if advancement of the colonoscope fails.

Amount of water infused and aspirated during insertion and withdrawal.

Patients willingness to repeat the examination based on overall satisfaction about procedure. Measured at discharge on a yes/no question.

Proportion of subjects with at least one adenoma of any size.

Proportion of subjects with at least one adenoma of any size in the proximal colon.

Proportion of subjects with at least one adenoma \<10 mm in the proximal colon.

Total number of adenomas resected per subject.

Cecal intubation will be defined as passage of the tip of the colonoscope beyond the ileocecal valve so that the medial wall of the cecum proximal to the ileocecal valve will be observed.

Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.

Total procedure time (including time required for polyp resection or biopsy).

Pain will be measured on a visual analogue scale (VAS) with a score 0=absence of pain, 1-2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patient. Patient will be informed that the request for pain information is not to remind that the examination should be uncomfortable, but to let the colonoscopist be alerted to the need to use maneuvers to minimize discomfort (e.g. loop reduction, removal of colonic content, abdominal compression and/or change in patient position). At regular intervals during colonoscopy (e.g. every 60 seconds) patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.

After the procedure and at discharge from the Endoscopy Unit, an assistant nurse blinded to the procedure will ask patients about maximum pain during insertion phase of the procedure using the same VAS when neither the endoscopist nor the assistant nurse who performed the colonoscopy will be present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.

All patients will be offered sedation for the procedure. Patients can accept or decline the medication. If they accept, the procedure will be started with the administration of 2 mg of Midazolam intravenously (minimal sedation). If the patient will choose on-demand sedation, minimal sedation will be offered when pain score reaches ≥2 on the VAS. Patients can accept or decline the offered medication. If they accept, minimal sedation will be administered as described above. To avoid bias by the colonoscopist, sedation medication will be administered based on the patients' confirmation that the pain is no longer tolerable, and not at the discretion of the colonoscopist. The colon segment in which patients requests sedation will be recorded. If additional medication will be required despite the abovementioned maneuvers and/or minimal sedation, it will be provided according to local standards and it will be recorded.

Presidio Ospedaliero Santa Barbara

Responsabile Servizio Endoscopia Digestiva

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

Air insufflation

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
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
Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening	NCT02041507	Colorectal Canc... Colorectal Aden... Colorectal Poly... Pain	Air insufflatio... Water Immersion... Water Exchange ...	50 Years - 70 Years	Presidio Ospedaliero Santa Barbara
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

Spots Global Cancer Trial Database for water immersion