Comparisons of SWI, WWI and CI in Potentially Difficult Colonoscopy.

NCT03571061 | Completed DMC

• 1 other identifier: SWI
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy insertion is technically challenging, time-consuming, and painful, especially for the sigmoid. It is reported that the difficult colonoscopy score (DCS) \>1 can predict the difficulty during colonoscopy. Patients with DCS\>1 had longer insertion time, higher pain score and needed more abdominal compression and position changes. As reported, water-aided method colonoscopy examination is an important and useful method because it reduces discomfort and increases cecal intubation rate compared with usual air insufflation method. But a longer time was consumed for scope insertion and cecal intubation in the traditional water-aided method colonscopy(the whole water immersion). To avoid these disadvantages ,we modified whole colon water immersion(WWI) method to the sigmoid colon water immersion(SWI), where the most difficult and painful part of colonoscopy resides. If water immersion is limited to the sigmoid colon in such patients, would it be more efficient and less time consuming? The aim of this study was to investigate the application of water-aided method on cecal intubation time in potentially difficult colonoscopy. This prospective, randomized controlled study allocated patients who's difficult colonoscopy score(DCS) \>1 (18-80 years) to sigmoid-colon water immersion(SWI), whole colon water immersion(WWI) or carbon dioxide (CO2) insufflation (CI) group (1:1:1). The primary outcome was cecal intubation time. The secondary outcomes included the maximum pain score (0=none,10=most severe) during the insertion phase in left, transverse and right colon; cecal intubation rate; adenoma detection rate(ADR); bowel preparation quality; withdrawal time(from cecum to rectum excluding time for biopsy and polypectomy); willingness to undergo a repeat unsedated colonoscopy; number of abdominal compressions, position change during the insertion. Patients were educated to understand the meaning of visual analogue scale (VAS) (0 = no pain, 10 = most severe) and to report their maximum pain scores during the insertion through each colonic segment. Descriptive statistics were used to summarize demographic and baseline data. Analyses were performed with SPSS software version 24.0 for Windows (SPSS Inc, IBM Company).

Conditions

Colonoscopy

Keywords

water-aided colonoscopy; difficult colonoscopy

Outcome Measures

Primary Outcomes (1)

• cecal intubation time

  the time the colonoscope advanced from the anus to the cecum

  3 months

Secondary Outcomes (2)

• maximum pain score

  3 months

• withdrawal time

  3 months

Study Arms (3)

whole colon water immersion group

ACTIVE COMPARATOR

whole colon water immersion group: the air supply was turn off until the cecum was reached. For adequate lumen distention to advance the colonoscope tip, warm water which stored in 1L bottles and maintained 37°C with a water bath, was instilled intermittently into the colon through the auxiliary working channel of colonoscope using a footswitch-controlled flushing pump

Procedure: whole colon water immersion and sigmoid water immersion

sigmoid water immersion group

EXPERIMENTAL

sigmoid water immersion group: air pump would be turned off and the procedure would be switched from water immersion method to air insufflation method after successful passage through the descending sigmoid junction.

Procedure: whole colon water immersion and sigmoid water immersion

carbon dioxide (CO2) insufflation

PLACEBO COMPARATOR

carbon dioxide (CO2) insufflation group: carbon dioxide (CO2) was insufflated through out the whole procedure for advancement and inspection when needed.

Procedure: whole colon water immersion and sigmoid water immersion

Interventions

whole colon water immersion and sigmoid water immersion PROCEDURE

we chose water immersion method instead of the triaditional method of carbon dioxide (CO2) insufflation.

Also known as: carbon dioxide (CO2) insufflation

carbon dioxide (CO2) insufflation; sigmoid water immersion group; whole colon water immersion group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing diagnostic, screening or surveillance colonoscopy
• their difficult colonoscopy score(DCS) \>1. DCS=1\*A(1 if age≥65y, 0 if \<65y) + 2\*B (1 if BMI \<18.5, 0 if BMI≥18.5) + 1\*C(1 if colonoscopist is junior, 0 if senior)+ 1\*S(1 if sleep quality was fair or bad, 0 if excellent or good).

You may not qualify if:

• history of colorectal resection;
• sedated colonoscopy;
• severe colonic stricture or obstructing tumor known before colonoscopy;
• current pregnancy;
• hemodynamic instability
• inability to provide informed consent.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China

Location

Related Publications (5)

• Jia H, Wang L, Luo H, Yao S, Wang X, Zhang L, Huang R, Liu Z, Kang X, Pan Y, Guo X. Difficult colonoscopy score identifies the difficult patients undergoing unsedated colonoscopy. BMC Gastroenterol. 2015 Apr 9;15:46. doi: 10.1186/s12876-015-0273-7.

  PMID: 25886845 BACKGROUND

• Zhang Z, Wu Y, Sun G, Zhang J, Li J, Qiu C, Zheng X, Wang B, Yang L, Wang X. Bayesian network meta-analysis: Efficacy of air insufflation, CO2 insufflation, water exchange, and water immersion in colonoscopy. Dig Endosc. 2018 May;30(3):321-331. doi: 10.1111/den.13012. Epub 2018 Feb 5.

  PMID: 29334136 BACKGROUND

• Cadoni S, Leung FW. Water-Assisted Colonoscopy. Curr Treat Options Gastroenterol. 2017 Mar;15(1):135-154. doi: 10.1007/s11938-017-0119-1.

  PMID: 28205108 BACKGROUND

• 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 BACKGROUND

• von Renteln D, Robertson DJ, Bensen S, Pohl H. Prolonged cecal insertion time is associated with decreased adenoma detection. Gastrointest Endosc. 2017 Mar;85(3):574-580. doi: 10.1016/j.gie.2016.08.021. Epub 2016 Aug 31.

  PMID: 27590962 BACKGROUND

MeSH Terms

Interventions

Carbon Dioxide; Insufflation

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Diagnostic Techniques and Procedures; Diagnosis; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 27, 2018
• Study Start: April 3, 2018
• Primary Completion: November 26, 2018
• Study Completion: December 26, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)