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

NCT01735266 | Completed DMC

• 1 other identifier: 20121108-5
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyp; Pain

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Cecum intubation time

  Insertion time from rectum to reach the cecum.

  up to three months

Secondary Outcomes (7)

• Pain scores

  up to two months

• Polyp detection rate

  up to six months

• Total procedure time

  up to two months

• Cecal intubation rate

  up to two months

• Withdrawal time

  up to two month

Study Arms (3)

Air colonoscopy

ACTIVE COMPARATOR

Air was insufflated during whole procedure of colonoscope insertion.

Other: Air colonoscopy

Whole-colon water exchange colonoscopy

EXPERIMENTAL

The air pump was turned off before colonoscopy. During the whole procedure of the scope insertion, residual air in lumen was suctioned and 37°C (maintained with a water bath) water was infused with a peristaltic pump to obtain lumen visualization. Air was insufflated until cecum was reached or appendix opening was seen.

Other: Water exchange colonoscopy

left-colon water exchange colonoscopy

EXPERIMENTAL

In the left side of colon (including descending colon, sigmoid colon and rectum), water was infused instead of air to obtain lumen visualization as described above in whole-colon water exchange colonoscopy group.

Other: Water exchange colonoscopy

Interventions

Air colonoscopy OTHER

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

Air colonoscopy

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.

Also known as: Water aided colonoscopy

Whole-colon water exchange colonoscopy; left-colon water exchange colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with unsedated colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

Related Publications (1)

• Wang X, Luo H, Xiang Y, Leung FW, Wang L, Zhang L, Liu Z, Wu K, Fan D, Pan Y, Guo X. Left-colon water exchange preserves the benefits of whole colon water exchange at reduced cecal intubation time conferring significant advantage in diagnostic colonoscopy - a prospective, randomized controlled trial. Scand J Gastroenterol. 2015 Jul;50(7):916-23. doi: 10.3109/00365521.2015.1010569. Epub 2015 Feb 1.

  PMID: 25639787 DERIVED

MeSH Terms

Conditions

Polyps; Pain

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yanglin Pan, M.D.

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: November 28, 2012
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

CN (1)