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Completed

NCT Number: NCT01485133

Water Method Colonoscopy in Patients With Prior Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cecal intubation success rate

    Time frame: up to ten months

    Insertion of a colonoscope to the cecum

Secondary outcomes

  1. Adenoma detection rate

    Time frame: up to ten months

    The proportion of participants with at least one adenoma in each group

  2. Pain Scores on the Visual Analog Scale

    Time frame: up to ten months

    0 = no pain, to 10 = most severe pain

  3. Cecum intubation time

    Time frame: up to ten months

    Total time of colonoscope intubation from anus to cecum

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2011
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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