Water Method Colonoscopy in Patients With Prior Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01485133
First received: November 30, 2011
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition
Intubation
Surgery
Adenoma
Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Water Colonoscopy Versus Air Colonoscopy for Unsedated Patients With Prior Abdominal or Pelvic Surgery: a Prospective Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Cecal intubation success rate [ Time Frame: up to ten months ] [ Designated as safety issue: No ]
    Insertion of a colonoscope to the cecum


Secondary Outcome Measures:
  • Adenoma detection rate [ Time Frame: up to ten months ] [ Designated as safety issue: No ]
    The proportion of participants with at least one adenoma in each group

  • Pain Scores on the Visual Analog Scale [ Time Frame: up to ten months ] [ Designated as safety issue: No ]
    0 = no pain, to 10 = most severe pain

  • Cecum intubation time [ Time Frame: up to ten months ] [ Designated as safety issue: No ]
    Total time of colonoscope intubation from anus to cecum


Enrollment: 110
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485133

Locations
China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Yanglin Pan, MD Fourth Military Medical University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01485133     History of Changes
Other Study ID Numbers: 20111103-9
Study First Received: November 30, 2011
Last Updated: November 6, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
colonoscopy
water
surgery
unsedated

ClinicalTrials.gov processed this record on September 22, 2014