Water Method Colonoscopy in Patients With Prior Surgery

NCT01485133 | Completed DMC

• 1 other identifier: 20111103-9
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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. Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the probable adhesion may change the anatomy and increase the discomfort of patients. We postulate that these patients may benefit from using the water method for colonoscopy. In this proposal we 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 prior abdominal or pelvic surgery. The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with prior abdominal or pelvic surgery. 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

Intubation; Surgery; Adenoma; Pain

Keywords

colonoscopy; water; surgery; unsedated

Outcome Measures

Primary Outcomes (1)

• Cecal intubation success rate

  Insertion of a colonoscope to the cecum

  up to ten months

Secondary Outcomes (3)

• Adenoma detection rate

  up to ten months

• Pain Scores on the Visual Analog Scale

  up to ten months

• Cecum intubation time

  up to ten months

Study Arms (2)

Air colonoscopy

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

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 via a needle adaptor or the built-in 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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with prior abdominal or pelvic surgery undergoing unsedated colonoscopy will be recruited in this study.

You may qualify if:

• Patients with prior abdominal or pelvic surgery,

You may not qualify if:

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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (6)

• Leung FW. Water exchange may be superior to water immersion for colonoscopy. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1012-4. doi: 10.1016/j.cgh.2011.09.007. Epub 2011 Sep 22. No abstract available.

  PMID: 21946120 BACKGROUND

• Leung FW, Leung JW, Mann SK, Friedland S, Ramirez FC. The water method significantly enhances patient-centered outcomes in sedated and unsedated colonoscopy. Endoscopy. 2011 Sep;43(9):816-21. doi: 10.1055/s-0030-1256407. Epub 2011 May 24.

  PMID: 21611947 BACKGROUND

• 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.

  PMID: 20619405 BACKGROUND

• Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.

  PMID: 20593332 BACKGROUND

• Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.

  PMID: 19555938 BACKGROUND

• Luo H, Zhang L, Liu X, Leung FW, Liu Z, Wang X, Xue L, Wu K, Fan D, Pan Y, Guo X. Water exchange enhanced cecal intubation in potentially difficult colonoscopy. Unsedated patients with prior abdominal or pelvic surgery: a prospective, randomized, controlled trial. Gastrointest Endosc. 2013 May;77(5):767-73. doi: 10.1016/j.gie.2012.12.007. Epub 2013 Feb 5.

  PMID: 23394837 DERIVED

MeSH Terms

Conditions

Adenoma; Pain

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanglin Pan, MD

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 5, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

CN (1)