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Completed

NCT Number: NCT01735266

Left-colon WEC May Reduce Insertion Time Compared With Whole-colon WEC.

In most of situation, left colon (especially SD junction) is considered the most difficult part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and patients may feel pain or uncomfortable. It is suggested more than half of the whole time for scope insertion should be used in left colon. Many methods, such as water immersion, abdominal palpation, have been used to facilitate insertion in left colon.

Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing medication used, pain experienced during colonoscopy, increasing the success rate of cecum intubation and adenoma detection rate in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents lengthening and distension of the colon during colonoscopy. This will facilitate the colonoscopy in average or difficult colonoscopy. However, it is not known whether the benefits of water exchange method of colonoscopy was mainly due to its effect on the left colon.

We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect regarding the maximal pain score and mean pain score in unsedated patients compared with whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion time compared with WWE. Here we performed a prospective, randomized controlled study to investigate the efficacies of whole-colon water exchange, left-colon water exchange and air methods of colonoscopy on pain score and insertion time in unsedated outpatients.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatients with unsedated colonoscopy

Exclusion criteria

  • history of colon resection
  • severe colonic stricture or obstructing tumor
  • hemodynamic instability
  • current pregnancy
  • inability to provide informed consent

Treatment and study plan

Air colonoscopy

Other

Colonoscopy will be performed with conventional air insufflation during colonoscope insertion.

Water exchange colonoscopy

Other

Water exchange method (The air pump was turned off before colonoscopy. During colonoscope insertion, residual air in lumen was suctioned and 37°C water was infused into lumen to obtain lumen visualization) was used in whole or left colon. Air was insufflated until cecum was reached or appendix opening was seen.

Other names: Water aided colonoscopy

Primary outcomes

  1. Cecum intubation time

    Time frame: up to three months

    Insertion time from rectum to reach the cecum.

Secondary outcomes

  1. Pain scores

    Time frame: up to two months

    Pain scores include mean pain score and maximal pain score.

    Mean pain score: mean value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).

    Maximal pain score: maximal value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).

  2. Polyp detection rate

    Time frame: up to six months

    The proportion of subjects with at least one polyp.

  3. Total procedure time

    Time frame: up to two months

    Total time of colonoscopic procedure.

  4. Cecal intubation rate

    Time frame: up to two months

    Percentage of successful colonoscopy (insertion of colonoscope into cecum).

  5. Withdrawal time

    Time frame: up to two month

    Withdrawal time is defined as the time from withdrawal of the colonoscope from the cecum to anal verge. (This time is measured independent of any therapeutic maneuvers, such as biopsy or polypectomy.)

  6. Patients willingness to repeat colonoscopy using same method

    Time frame: up to two month

    When after the colonoscopic examination, patients were asked if they have willingness to repeat the colonoscopy using same method.

  7. Procedure difficulty evaluated by endoscopist

    Time frame: up to two month

    When after the colonoscopy, endoscopist were asked to score on the difficulty of the colonoscopic procedure.

    0-very easy, 10-very difficult

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Comparative Efficacy of Whole-colon Water Exchange, Left-colon Water Exchange and Air Methods of Colonoscopy on Cecum Intubation in Unsedated Outpatients - - - a Prospective, Randomized Controlled Trail

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2012
Registry last updated
Sep 12, 2013

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

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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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