Water Method in Patients With Incomplete Colonoscopy

NCT ID: NCT01546246

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-12-31

Brief Summary

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Colonoscopy has been considered the gold standard procedure in screening for colorectal disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult anatomy and prior abdominal or pelvic surgery. The investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with immediately failed colonoscopy.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with incomplete colonoscopy. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.

Conditions

Failed or Difficult Intubation; Adenoma; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Air colonoscopy

Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Water colonoscopy

Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.

Group Type: OTHER

Water colonoscopy

Intervention Type: OTHER

Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.

Interventions

Water colonoscopy

Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.

Intervention Type: OTHER

Other Intervention Names

Water; colonoscopy

Eligibility Criteria

Inclusion Criteria

• Patients with incomplete colonoscopy

Exclusion Criteria

• History of colorectal surgery
• Severe colonic stricture or obstructing tumor
• Patients who cannot give informed consent and those who are hemodynamically unstable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanglin Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

20120216-6

Identifier Type: -

Identifier Source: org_study_id