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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2018-12-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Experienced Endoscopists

NCT01797406

Colon Disease; Rectal Disease;

UNKNOWN NA

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

NCT01735266

Polyp Pain

COMPLETED NA

A Study on a New Indicator for Assessing the Difficulty of Colonoscopy Insertion and Its Related Factors

NCT07228715

the Difficulty of Colonoscopy Insertion

ACTIVE_NOT_RECRUITING

"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

NCT01797393

Colon Disease; Rectal Disease

UNKNOWN NA

Evaluation of the Impact of Water Method During Insertion Phase of Flexible Sigmoidoscopy in Training

NCT03208283

Colorectal Cancer Screening

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

whole colon water immersion group

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

Group Type ACTIVE_COMPARATOR

whole colon water immersion and sigmoid water immersion

Intervention Type PROCEDURE

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

sigmoid water immersion group

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.

Group Type EXPERIMENTAL

whole colon water immersion and sigmoid water immersion

Intervention Type PROCEDURE

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

carbon dioxide (CO2) insufflation

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

Group Type PLACEBO_COMPARATOR

whole colon water immersion and sigmoid water immersion

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

whole colon water immersion and sigmoid water immersion

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

carbon dioxide (CO2) insufflation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. patients undergoing diagnostic, screening or surveillance colonoscopy
2. 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).

Exclusion Criteria

1. history of colorectal resection;
2. sedated colonoscopy;
3. severe colonic stricture or obstructing tumor known before colonoscopy;
4. current pregnancy;
5. hemodynamic instability
6. inability to provide informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes