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

Colon Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699399
• Other study ID #: DTCRD101(2)-E-03
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2018

Study information

• Verified date: May 2019
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing colonoscopy performed by the endoscopist at our endoscopic suite

Exclusion Criteria:

• request for sedation, indicated for bidirectional endoscopy, obstructive lesions of the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA) risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.

Related Conditions & MeSH terms

• Colon Neoplasm
• Colonic Neoplasms

Intervention

Procedure:
• water immersion

• water exchange

• air insufflation

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi General Hospital	Chia-Yi

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236. — View Citation

Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8. — View Citation

Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post-procedure discomforts and 30 days complication rate	telephone follow up for post-procedure discomforts and 30 days complication rate	one month
Primary	Proportions of patients requiring sedation		3 months
Secondary	patient pain during insertion		3 months