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

NCT ID: NCT01735266

Last Updated: 2013-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Air colonoscopy

Air was insufflated during whole procedure of colonoscope insertion.

Group Type: ACTIVE_COMPARATOR

Air colonoscopy

Intervention Type: OTHER

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

Whole-colon water exchange colonoscopy

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.

Group Type: EXPERIMENTAL

Water exchange colonoscopy

Intervention Type: 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.

left-colon water exchange colonoscopy

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.

Group Type: EXPERIMENTAL

Water exchange colonoscopy

Intervention Type: 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.

Interventions

Air colonoscopy

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

Intervention Type: OTHER

Water exchange colonoscopy

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.

Intervention Type: OTHER

Other Intervention Names

Water aided colonoscopy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanglin Pan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 25639787 (View on PubMed)

Other Identifiers

20121108-5

Identifier Type: -

Identifier Source: org_study_id