GOALS: To test the hypothesis that water exchange (WE) significantly increases adenoma detection rates (ADR) compared with water immersion (WI). BACKGROUND: Low ADR was linked to increased risk for interval colorectal cancers and related deaths. Two recent randomized controlled trials of head-to-head comparison of WE, WI, and traditional air insufflation (AI) each showed that WE achieved significantly higher ADR than AI, but not WI. The data were pooled from these 2 studies to test the above hypothesis. STUDY: Two trials (5 sites, 14 colonoscopists) that randomized 1875 patients 1:1:1 to AI, WI, or WE were pooled and analyzed with ADR as the primary outcome. RESULTS: The ADR of AI (39.5%) and WI (42.4%) were comparable, significantly lower than that of WE (49.6%) (vs. AI P=0.001; vs. WI P=0.033). WE insertion time was 3 minutes longer than that of AI (P<0.001). WE showed significantly higher detection rate (vs. AI) of the >10 mm advanced adenomas. Right colon combined advanced and sessile serrated ADR of AI (3.4%) and WI (5%) were comparable and were significantly lower than that of WE (8.5%) (vs. AI P<0.001; vs. WI P=0.039). CONCLUSIONS: Compared with AI and WI, the superior ADR of WE offsets the drawback of a significantly longer insertion time. For quality improvement focused on increasing adenoma detection, WE is preferred over WI. The hypothesis that WE could lower the risk of interval colorectal cancers and related deaths should be tested.
- MeSH
- adenom diagnóza MeSH
- insuflace MeSH
- kolonoskopie metody MeSH
- kolorektální nádory diagnóza MeSH
- lidé středního věku MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- senzitivita a specificita MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- práce podpořená grantem MeSH
- Research Support, U.S. Gov't, Non-P.H.S. MeSH
Background and study aims Single-center studies, which were retrospective and/or involved unblinded colonoscopists, have suggested that water exchange, but not water immersion, compared with air insufflation significantly increases the adenoma detection rate (ADR), particularly in the proximal and right colon. Head-to-head comparison of the three techniques with ADR as primary outcome and blinded colonoscopists has not been reported to date. In a randomized controlled trial with blinded colonoscopists, we aimed to evaluate the impact of the three insertion techniques on ADR.Patients and methods A total of 1224 patients aged 50 - 70 years (672 males) and undergoing screening colonoscopy were randomized 1:1:1 to water exchange, water immersion, or air insufflation. Split-dose bowel preparation was adopted to optimize colon cleansing. After the cecum had been reached, a second colonoscopist who was blinded to the insertion technique performed the withdrawal. The primary outcome was overall ADR according to the three insertion techniques (water exchange, water immersion, and air insufflation). Secondary outcomes were other pertinent overall and right colon procedure-related measures.Results Baseline characteristics of the three groups were comparable. Compared with air insufflation, water exchange achieved a significantly higher overall ADR (49.3 %, 95 % confidence interval [CI] 44.3 % - 54.2 % vs. 40.4 % 95 %CI 35.6 % - 45.3 %;P = 0.03); water exchange showed comparable overall ADR vs. water immersion (43.4 %, 95 %CI 38.5 % - 48.3 %;P = 0.28). In the right colon, water exchange achieved a higher ADR than air insufflation (24.0 %, 95 %CI 20.0 % - 28.5 % vs. 16.9 %, 95 %CI 13.4 % - 20.9 %;P = 0.04) and a higher advanced ADR (6.1 %, 95 %CI 4.0 % - 9.0 % vs. 2.5 %, 95 %CI 1.2 % - 4.6 %;P = 0.03). Compared with air insufflation, the mean number of adenomas per procedure was significantly higher with water exchange (P = 0.04). Water exchange achieved the highest cleanliness scores (overall and in the right colon). These variables were comparable between water immersion and air insufflation.Conclusions The design with blinded observers strengthens the validity of the observation that water exchange, but not water immersion, can achieve significantly higher adenoma detection than air insufflation. Based on this evidence, the use of water exchange should be encouraged.Trial registered at ClinicalTrials.gov (NCT02041507).
- MeSH
- adenom diagnostické zobrazování MeSH
- časná detekce nádoru metody MeSH
- colon ascendens MeSH
- colon transversum MeSH
- dvojitá slepá metoda MeSH
- insuflace MeSH
- kolonoskopie metody MeSH
- léčebná irigace metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory tračníku diagnostické zobrazování MeSH
- purgativa aplikace a dávkování MeSH
- senioři MeSH
- voda MeSH
- vzduch MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Single site studies in male Veterans in the U.S. reported increased detection of presumptive cancer precursors (adenomas, hyperplastic polyps) in the proximal colon (cecum-splenic flexure) by water exchange. AIMS: Assess the reproducibility of the observation. METHODS: Analysis of secondary outcomes collected prospectively in 3 similarly designed randomized controlled trials using water exchange, water immersion and insufflation (air or carbon dioxide). MAIN OUTCOME: detection rates of adenomas and hyperplastic polyps in proximal, transverse and right colon (cecum-ascending). RESULTS: 704 males (173 screening) were evaluated. In the proximal colon, WE showed increased detection of small adenomas (p=0.009) and adenomas plus hyperplastic polyps (p=0.015) (vs insufflation); increased detection of adenomas plus hyperplastic polyps of any size (p=0.045) and of small size (p=0.04) (vs water immersion). In the right colon water exchange increased detection of small adenomas (19% vs 12.1%, p=0.04) (vs insufflation); small adenomas (19% vs 12%, p=0.038), adenomas plus hyperplastic polyps of any size (25% vs 16.7%, p=0.028) and of small size (23.7% vs 14.6%, p=0.012) (vs water immersion). Water exchange significantly improved bowel cleanliness. Sedation had no impact on lesion detection. CONCLUSIONS: Water exchange is a superior insertion technique for detection of adenomas and hyperplastic polyps primarily in the right colon, especially those of small size.
- MeSH
- adenom diagnóza MeSH
- časná detekce nádoru MeSH
- cékum patologie MeSH
- colon ascendens patologie MeSH
- hyperplazie MeSH
- kolonoskopie metody MeSH
- kolorektální nádory diagnóza MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- plošný screening metody MeSH
- polypy tlustého střeva diagnóza patologie MeSH
- reprodukovatelnost výsledků MeSH
- senioři MeSH
- voda MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Česká republika MeSH
- Itálie MeSH
- Spojené státy americké MeSH
BACKGROUND: Low adenoma detection rate (ADR) predicts development of interval cancers, found mainly in the right (cecum-ascending) colon, where poor bowel preparation is an associated factor. Single-site studies reported increased detection of adenomas in the proximal colon segments by water exchange (WE). Data about colon cleansing revealed that WE had the greatest impact in the right colon. AIMS: To test the hypothesis that WE had the greatest impact on ADR in colon segments with the most favorable bowel cleanliness scores, namely the right colon. METHODS: We pooled right colon and overall ADR data of three similarly designed colonoscopy trials that compared WE, water immersion (WI) and insufflation of air or carbon dioxide (AICD) in a mixed gender European population. RESULTS: In this study, 1200 (704 males) subjects and were included. 288 were screening cases. Demographic and procedural data were comparable. Water exchange achieved significantly higher right colon <10 mm ADR (11.9 %, vs WI 6.9 %, p = 0.016; vs AICD 7.2 %, p = 0.025). Water exchange achieved the lowest proportions of poor bowel preparation and the highest right colon and overall Boston bowel preparation scale scores (p range 0.003, <0.0005). In patients with right colon excellent bowel cleanliness, water exchange was the only method significantly associated with right colon adenoma detection. One of the limitations is unblinded colonoscopists. CONCLUSIONS: In a mixed gender European population, water exchange is confirmed to be a superior insertion technique showing a significant increase in <10 mm right colon adenoma detection, achieving the cleanest colon and lowest proportions of poor bowel preparation requiring repeat procedures. CLINICALTRIALS. GOV NO: NCT01781650, 01954862, 01780818.
- MeSH
- adenom diagnóza patologie MeSH
- časná detekce nádoru MeSH
- colon ascendens patologie MeSH
- kolonoskopie metody MeSH
- kolorektální nádory diagnóza patologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND & AIMS: Unsedated colonoscopy is acceptable for diagnostic, surveillance, and screening indications worldwide. However, insertion of the colonoscope can be painful; it is not clear which technique is least painful and thereby increases the likelihood of colonoscopy completion. We performed a head-to-head comparison of air insufflation (AI), carbon dioxide (CO2) insufflation, water immersion (WI), and water exchange (WE) to determine which combination of insertion techniques produces the least amount of pain. METHODS: In a patient-blinded prospective trial, 624 subjects were assigned randomly to groups that underwent colonoscopy with AI-AI, CO2-CO2, WI-AI, WE-AI, WI-CO2, or WE-CO2 insertion and withdrawal techniques, including on-demand sedation, at the St. Barbara Hospital (Iglesias, Italy) or the Vìtkovice Hospital (Ostrava, Czech Republic), from October 2013 through June 2014. The primary outcome was real-time maximum insertion pain (0 = none, 10 = worst), recorded by an unblinded nurse assistant. At discharge, a blinded observer recorded the recalled maximum insertion pain and patients' and investigators' guesses about method or gas used. RESULTS: Patients and investigators correctly guessed the method used for fewer than 44% of procedures, confirming adequate blinding. The correlation between real-time and recalled maximum insertion pain (r = 0.9; P < .0005) confirmed internal validation of the primary outcome. The WE group had the lowest scores: mean pain values were 5.2 for AI-AI (95% confidence interval [CI], 4.6-5.8), 4.9 for CO2-CO2 (95% CI, 4.3-5.4), 4.3 for WI-CO2 (95% CI, 3.8-4.9), 4.0 for WI-AI (95% CI, 3.5-4.5), 3.1 for WE-CO2 (95% CI, 2.7-3.4), and 3.1 for WE-AI (95% CI, 2.7-3.6) (P < .0005). The highest proportions of patients completing unsedated colonoscopy were in the WE groups. WE groups also had significantly better colon cleanliness, particularly in the transverse and right colon (P < .0005). One limitation of the study was that colonoscopists and assistants were not blinded to water-aided insertion methods. CONCLUSIONS: In a prospective study of colonoscopy insertion methods, CO2 insufflation did not reduce real-time maximum insertion pain. Compared with AI or CO2, WI and WE reduced insertion pain. The least painful technique was WE, which significantly increased completion of unsedated colonoscopy and bowel cleanliness without prolonging insertion time. ClinicalTrials.gov number: NCT01954862.
- MeSH
- bolest * MeSH
- dospělí MeSH
- jednoduchá slepá metoda MeSH
- kolonoskopie škodlivé účinky metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- zvířata MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
- Itálie MeSH