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ColonoscopyNCT03571061

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

A study testing whole colon water immersion and sigmoid water immersion in people with Colonoscopy, run by Shenzhen People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Colonoscopy
What is being tested?
whole colon water immersion and sigmoid water immersion
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteChina
Study dates
3 Apr 2018to 26 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518000

Other trials in China

About this study

Official title: Comparisons of Sigmoid-colon Water Immersion, the Whole Colon Water Immersion and Carbon Dioxide (CO2) Insufflation on Cecal Intubation Time in Potentially Difficult Colonoscopy by Difficult Colonoscopy Score(DCS) >1.

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).

Read the detailed description

Introduction: Colonoscopy insertion is technically challenging, time-consuming, and painful, especially for the sigmoid. Many factors have been found to affect the difficulty of colonoscope insertion, such as age, gender, body mass index, history of abdominal surgery and operator ect. It is reported that the difficult colonoscopy score (DCS) >1 can predict the difficulty during colonoscopy. 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). Patients with DCS>1 had longer insertion time, higher pain score and needed more abdominal compression and position changes. For these potentially difficult cases we can use special intubation techniques such as water-aided or cap-assisted method at the very start to avoid of excessive insertion time, increased discomfort and even unnecessary adverse events.

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. This examination is usually performed using two different methods: water immersion and water exchange. In the water immersion method, the water is infused into the colon beginning with the scope inserted into the anus during examination until the scope reaches the cecum. The water is evacuated during colonoscope withdrawal. In the water exchange method, the water is evacuated during colonoscope advancement until the cecum is reached. The air pump of the endoscopy machine is turned off during examination in both procedures. The aim of this study was to investigate the application of water-aided method on cecal intubation time in potentially difficult colonoscopy. We chose water immersion method rather than water exchange for this evaluation because water immersion, characterized by suction removal of the infused water predominantly during withdrawal, is more appropriate for reducing the cecal intubation time. Further more ,as reported, left-colon water exchange(LWE) shorten the insertion time while preserving the benefits of whole colon water exchange(WWE). 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? Methods: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). Patients were randomized to SWI, WWI or CI group according to a computer-generated randomization list in 1:1:1 ratio. Group assignments were revealed immediately before the insertion of colonoscopy by a researcher , who did not participate in data collection and data analysis. The monitor screen was placed over the head of patients to keep them from knowing the insertion method. Endoscopists and assisting nurses were not blinded. For the bowel preparation, all patients were instructed to take low-fiber diet for lunch and clear liquid diets for dinner the day before examination. They ingested 2L of PEG powder (WanHe Pharmaceutical Co, Shenzhen, China) diluted with water within 2 h, between 4:00 AM and 5:00 AM on the day of the examination. Those with chronic constipation received an additional 2L of PEG solution on the evening prior to the examination. Drinking more clear water and pacing back and forth after purgatives were encouraged to enhance laxative effect. The time interval between preparation and colonoscopy was limited to less than 5 h to ensure the quality of bowel preparation.

Endoscopic procedure Two endoscopists (WBH and YJ) with extensive experience in both air (>5000) and water methods (>500) performed the colonoscopies. The standard adult colonoscope (EC-600WM, Fujinon, Beijing) was used. Patients were placed in the left lateral position at the beginning of the procedure. Maneuvers such as abdominal compression and position change were implemented if needed (e.g. when looping, paradoxical movement or lack of advancement occurred). Successful cecal intubation was confirmed by the visualization of appendiceal orifice or ileocecal valve with the tip of the colonoscope touching the base of the cecum. For the AI method, air was insufflated through out the whole procedure for advancement and inspection when needed. In the WWI method,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. For patients allocated to SWI 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.

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 insert.

Descriptive statistics were used to summarize demographic and baseline data. Quantitative variables are expressed as means and standard deviations and analyzed by ANOVA followed by Bonferroni test for multiple comparisons. Categorical variables in three groups were compared with chi-square test or Fisher exact test when appropriate. All p-Values were two-sided and those < 0.05 were considered to be significant. Analyses were performed with SPSS software version 24.0 for Windows (SPSS Inc, IBM Company).

Conditions
Colonoscopy
Being tested
whole colon water immersion and sigmoid water immersion
Keywords
water-aided colonoscopy; difficult colonoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • whole colon water immersion and sigmoid water immersionProcedure or surgery

    Also called carbon dioxide (CO2) insufflation

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

Study groups in NCT03571061
Study groupRoleWhat they receive
whole colon water immersion groupActive comparatorwhole 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
Receives: Procedure: whole colon water immersion and sigmoid water immersion
sigmoid water immersion groupExperimentalsigmoid 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.
Receives: Procedure: whole colon water immersion and sigmoid water immersion
carbon dioxide (CO2) insufflationPlacebo comparatorcarbon dioxide (CO2) insufflation group: carbon dioxide (CO2) was insufflated through out the whole procedure for advancement and inspection when needed.
Receives: Procedure: whole colon water immersion and sigmoid water immersion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cecal intubation time

    the time the colonoscope advanced from the anus to the cecum

    Measured: 3 months

Secondary outcomes (2)
  1. maximum pain score

    0=none, 10=most severe

    Measured: 3 months

  2. withdrawal time

    from cecum to rectum excluding time for biopy and polypectomy

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2018
  2. Study start3 Apr 2018
  3. Primary completion26 Nov 2018
  4. Study completion26 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571061
Sponsor's protocol ID
SWI
Status last verified
Apr 2018
First submitted
28 May 2018
Last updated
2 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25886845
  • 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.

    PubMed 29334136
  • Cadoni S, Leung FW. Water-Assisted Colonoscopy. Curr Treat Options Gastroenterol. 2017 Mar;15(1):135-154. doi: 10.1007/s11938-017-0119-1.

    PubMed 28205108
  • 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.

    PubMed 25639787
  • 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.

    PubMed 27590962

Questions about this trial

What is this clinical trial studying?

A study testing whole colon water immersion and sigmoid water immersion in people with Colonoscopy, run by Shenzhen People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cecal intubation time (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571061, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.

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