Paolo Gallittu

A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy

BACKGROUND AND STUDY AIM Water-aided colonoscopy includes water immersion and water exchange. Several small single-center studies have suggested that the use of water rather than air insufflation during colonoscopy reduces pain on insertion. The aim of this study was to investigate whether water-aided colonoscopy is less painful than air insufflation in a large cohort of patients. PATIENTS AND METHODS This was a two-center, randomized controlled trial. Consecutive patients who agreed to start colonoscopy without premedication were included. Sedation was administered on demand. Water-aided colonoscopy was performed using water immersion in the early phase of the study, and subsequently water exchange was used. The primary endpoint was cecal intubation with pain scores of ≤ 2 and sedation with no or ≤ 2 mg midazolam. Secondary outcomes were pain score at discharge, cecal intubation rate and time, and adenoma detection rate (ADR). RESULTS A total of 672 patients were randomized to water exchange (n = 338) or air insufflation (n = 334). The primary endpoint was achieved in more patients in the water exchange group (83.8 % vs. 62 %; P < 0.0005). On-demand sedation was also required less (11.5 % vs. 26.0 %; P < 0.0005) and mean pain score was lower (1.3 vs. 2.3; P < 0.0005) in the water exchange group. The cecal intubation rates were comparable. Water exchange had a significantly higher overall ADR (25.8 % vs. 19.1 %; P = 0.041), proximal ADR (10.1 % vs. 4.8 %; P = 0.014), and proximal < 10 mm ADR (7.7 % vs. 3.9 %; P = 0.046); proximal ADR was also higher in screening-only patients in the water exchange group (18.9 % vs. 7.4 %; P  = 0.015). No detailed analysis was possible for the air insufflation vs. water immersion comparison. CONCLUSION The current results confirmed that water exchange minimized the requirement for sedation and increased the ADR.

Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial

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).

Insertion water exchange increases right colon adenoma and hyperplastic polyp detection rates during withdrawal

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.

Evidence to suggest adoption of water exchange deserves broader consideration: Its pain alleviating impact occurs in 90% of investigators

AIM To determine whether observations were reproducible among investigators. METHODS From March 2013 through June 2014, 18-85-year-old diagnostic and 50-70-year-old screening patients were enrolled at each center to on-demand sedation colonoscopy with water exchange (WE), water immersion (WI) and insufflation with air or CO2 for insertion and withdrawal [air or carbon dioxide (AICD)]. Data were aggregated for analysis. PRIMARY OUTCOME Variations in real-time maximum insertion pain (0 = none, 1-2 = discomfort, 10 = worst). RESULTS One thousand and ninety-one cases analyzed: WE (n = 371); WI (n = 338); AICD (n = 382). Demographics and indications were comparable. The WE group had the lowest real-time maximum insertion pain score, mean (95%CI): WE 2.8 (2.6-3.0), WI 3.8 (3.5-4.1) and AICD 4.4 (4.1-4.7), P < 0.0005. Ninety percent of the colonoscopists were able to use water exchange to significantly decrease maximum insertion pain scores. One investigator had high insertion pain in all groups, nonetheless WE achieved the lowest real-time maximum insertion pain score. WE had the highest proportions of patients with painless unsedated colonoscopy (vs WI, P = 0.013; vs AICD, P < 0.0005); unsedated colonoscopy with only minor discomfort (vs AICD, P < 0.0005), and completion without sedation (vs AICD, P < 0.0005). CONCLUSION Aggregate data confirm superiority of WE in lowering colonoscopy real-time maximum insertion pain and need for sedation. Ninety percent of investigators were able to use water exchange to significantly decrease maximum insertion pain scores. Our results suggest that the technique deserves consideration in a broader scale.

Underwater endoscopic colorectal polyp resection: Feasibility in everyday clinical practice

Background Endoscopic mucosal resection is well-established for resecting flat or sessile benign colon polyps. The novel underwater endoscopic mucosal resection eschews submucosal injection prior to endoscopic mucosal resection. Reports about underwater endoscopic mucosal resection were limited to small series of single and/or tertiary-care referral centers, with single or supervised operators. Objective The purpose of this study was to determine feasibility and efficacy of underwater resection of polyps of any morphology (underwater polypectomy, here includes underwater endoscopic mucosal resection) in routine clinical practice. Methods This study involved a comparison of colonoscopy records of two community hospitals (January 2015–December 2016) for underwater polypectomy (n = 195) and gas insufflation polypectomy (n = 186). Results Comparable demographics, procedural data, overall distribution, morphology and size of resected lesions, number of en bloc and R0 resections (any polyp morphology and size); exception: overall, underwater polypectomy pedunculated polyps were significantly larger than those in the gas insufflation polypectomy group, p = 0.030. Underwater polypectomy (median, min) resection time was significantly shorter than gas insufflation polypectomy: sessile and flat polyps 6–9 mm, 0.8 vs 2.7 (p = 0.040); 10–19 mm, 2.0 vs 3.3 (p = 0.025), respectively; pedunculated polyps 6–19 mm, 0.8 vs 3.3 (p < 0.001). Underwater polypectomy resection of pedunculated polyps 6–19 mm showed significantly less immediate bleeding: 11.1% vs 1.5%, respectively (p = 0.031). Conclusions Underwater polypectomy can be efficaciously used in routine clinical practice for the complete resection of colon polyps, with several advantages over gas insufflation polypectomy.

Feasibility, Safety and Diagnostic Yield of Omom Ce, a New Capsule Endoscopy System: The First Experience in Caucasian Patients

Small bowel evaluation has been considered for a long time technically challenging because of its length, location and tortuosity. But in 2001, with the FDA approval of capsule endoscopy started a revolution in the study of small bowel that, in the last years, has progressively and rapidly expanded [1-5]. Nevertheless, one of the main limitations to the spread of capsule endoscopy is the high cost and therefore a questionable cost-effectiveness when used in clinical practice. Lately the picture could change to the introduction in the European of a new video capsule system (OMOM CE) produced by Jinshan Science & Technology Company (Chongqing, China) [6, 7]; this device has and obtained the CE mark for marketing in Europe. Indeed, this device costs approximately half the other capsule systems. However, to date only few studies have been performed on the use in clinical practice of this new video capsule system, and none of them was carried out in the western world.