Water Method Colonoscopy in Patients With Prior Surgery

Pain Clinical Trial

Official title:

Water Colonoscopy Versus Air Colonoscopy for Unsedated Patients With Prior Abdominal or Pelvic Surgery: a Prospective Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485133
• Other study ID #: 20111103-9
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: November 6, 2012
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with prior abdominal or pelvic surgery,

Exclusion Criteria:

• History of colorectal surgery

• Severe colonic stricture or obstructing tumor

• Patients who cannot give informed consent and those who are hemodynamically unstable

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenoma
• Intubation
• Pain
• Surgery

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal intubation success rate	Insertion of a colonoscope to the cecum	up to ten months	No
Secondary	Adenoma detection rate	The proportion of participants with at least one adenoma in each group	up to ten months	No
Secondary	Pain Scores on the Visual Analog Scale	0 = no pain, to 10 = most severe pain	up to ten months	No
Secondary	Cecum intubation time	Total time of colonoscope intubation from anus to cecum	up to ten months	No