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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01735266
Enrollment
300
Registered
2012-11-28
Start date
2013-05-31
Completion date
2013-08-31
Last updated
2013-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyp, Pain

Keywords

Colonoscopy

Brief summary

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.

Interventions

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

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.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cecum intubation timeup to three monthsInsertion time from rectum to reach the cecum.

Secondary

MeasureTime frameDescription
Polyp detection rateup to six monthsThe proportion of subjects with at least one polyp.
Total procedure timeup to two monthsTotal time of colonoscopic procedure.
Cecal intubation rateup to two monthsPercentage of successful colonoscopy (insertion of colonoscope into cecum).
Pain scoresup to two monthsPain 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).
Patients willingness to repeat colonoscopy using same methodup to two monthWhen after the colonoscopic examination, patients were asked if they have willingness to repeat the colonoscopy using same method.
Procedure difficulty evaluated by endoscopistup to two monthWhen after the colonoscopy, endoscopist were asked to score on the difficulty of the colonoscopic procedure. 0-very easy, 10-very difficult
Withdrawal timeup to two monthWithdrawal 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.)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026