RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees
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ABSTRACT:
DISEASE(S): Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2067762 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
| 2063568 | ecrin-mdr-crc
Project description:This study evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. It compares the differences between complete colon exam rates for water exchange when compared to the traditional air technique. Patients will be randomised and blinded to the procedure type.
Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. However, the potential for water exchange to be used in the screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy screening, while maintaining minimal levels of discomfort, the investigators will attempt to scope beyond the distal colon.
| 2248694 | ecrin-mdr-crc
Project description:Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in average-risk screening patients. Several other secondary outcomes will also be analyzed.
| 2139246 | ecrin-mdr-crc
Project description:Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.
| 2139310 | ecrin-mdr-crc
Project description:Visualization during GI endoscopy requires distention of the bowel lumen. Carbon dioxide (CO(2)) insufflation decreases postprocedure abdominal discomfort and distension after colonoscopy, but there have been few published studies on its use in ERCP.To assess the safety and efficacy of CO(2) insufflation during ERCP.Double-blind, controlled, randomized trial.Tertiary-care referral center.This study involved consecutive patients referred for ERCP, excluding those with known CO(2) retention or with chronic use of opiate medications.Insufflation of CO(2) versus insufflation of air.Primary outcomes were abdominal pain assessed on a visual analogue scale and abdominal distension. Secondary outcomes included transcutaneous CO(2) levels (pCO(2)) and procedural complications.We analyzed 74 patients, 38 in the air group and 36 in the CO(2) group. Pain scores were similar in both groups 1-hour postprocedure (16 vs 11 mm in the CO(2) and air groups, respectively; P = .29) as well as over the subsequent 24 hours. There were also no significant differences between groups in abdominal distension or pCO(2) levels. There were 13 patients with complications in the air group and 5 in the CO(2) group (P = .04; nominal significance removed by Bonferroni correction), although most complications were minor in nature.Single-center study.The use of CO(2) for insufflation during ERCP was safe in a tertiary-care referral population. However, use of CO(2) during ERCP did not lead to decreased postprocedural pain or less abdominal distension, so its role in this procedure remains in question. NCT00685386.
| S-EPMC2902617 | biostudies-literature
Project description:Background/aimsThis study aimed to compare tolerance to air, carbon dioxide, or water insufflation in patients with anticipated difficult colonoscopy (young, thin, obese individuals, and patients with prior abdominal surgery or irradiation).MethodsPatients with body mass index (BMI) less than 18 kg/m2 or more than 30 kg/m2, or who had undergone previous abdominal or pelvic surgeries were randomized to air, carbon dioxide, or water insufflation during colonoscopy. The primary endpoint was cecal intubation with mild pain (less than 5 on visual analogue scale [VAS]), without use of sedation.ResultsThe primary end point was achieved in 32.7%, 43.8%, and 84.9% of cases with air, carbon dioxide and water insufflation (P<0.001). The mean pain scores were 5.17, 4.72, and 3.93 on the VAS for air, carbon dioxide, and water insufflation (P<0.001). The cecal intubation rate or procedure time did not differ significantly between the 3 groups.ConclusionsWater insufflation was superior to air or carbon dioxide for pain tolerance. This was seen in the subgroups with BMI <18 kg/m2 and the post-surgical group, but not in the group with BMI >30 kg/m2.
| S-EPMC5934604 | biostudies-literature
Project description:Interventions: We use low pressure air insufflation instead of high pressure during insertion phase of colonoscopy. Air insufflation is usually needed during colonoscopy. There are 3 air pressure level of air pressures on the control panel: high, median and low. Traditionaly, high pressure (0.05 MPa) is used. In this study, we use low pressure (0.0075-0.015 MPa) during insertion phase of colonoscopy to minimize loop formation. Before the colonoscopy is started, the air pressure was switched to low level on the control panel.
Primary outcome(s): to reduce cecal intubation time by one minute[At the end of colonoscopy]
Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel
| 2454097 | ecrin-mdr-crc
Project description:The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer.
Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm, P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy.
Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy.
In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the proximal colon.
In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy.
We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for further testing that WE may provide a strategy to improve prevention of colorectal cancer by increasing detection of adenomas in screening colonoscopy.
Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases of colonoscopy will be done by different investigators. The second investigator will be blinded to the method used to insert the instrument, thus eliminating possible bias about procedure related issues.
Several secondary outcomes will also be analysed.
| 2159184 | ecrin-mdr-crc
Project description:Carbon dioxide (CO2) insufflation is increasingly used for endoscopic submucosal dissection (ESD) owing to the faster absorption of CO2 as compared to that of air. Studies comparing CO2 insufflation and air insufflation have reported conflicting results.This meta-analysis is aimed to assess the efficacy and safety of use of CO2 insufflation for ESD.Clinical trials of CO2 insufflation versus air insufflation for ESD were searched in PubMed, Embase, the Cochrane Library and Chinese Biomedical Literature Database. We performed a meta-analysis of all randomized controlled trials (RCTs).Eleven studies which compared the use of CO2 insufflation and air insufflation, with a combined study population of 1026 patients, were included in the meta-analysis (n = 506 for CO2 insufflation; n = 522 for air insufflation). Abdominal pain and VAS scores at 6h and 24h post-procedure in the CO2 insufflation group were significantly lower than those in the air insufflation group, but not at 1h and 3h after ESD. The percentage of patients who experienced pain 1h and 24h post-procedure was obviously decreased. Use of CO2 insufflation was associated with lower VAS scores for abdominal distention at 1h after ESD, but not at 24h after ESD. However, no significant differences were observed with respect to postoperative transcutaneous partial pressure carbon dioxide (PtcCO2), arterial blood carbon dioxide partial pressure (PaCO2), oxygen saturation (SpO2%), abdominal circumference, hospital stay, white blood cell (WBC) counts, C-Reactive protein (CRP) level, dosage of sedatives used, incidence of dysphagia and other complications.Use of CO2 insufflation for ESD was safe and effective with regard to abdominal discomfort, procedure time, and the residual gas volume. However, there appeared no significant differences with respect to other parameters namely, PtcCO2, PaCO2, SpO2%, abdominal circumference, hospital stay, sedation dosage, complications, WBC, CRP, and dysphagia.
| S-EPMC5443502 | biostudies-literature
Project description:Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum.
WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen.
In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed.
Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients’ higher willingness to repeat the procedure.
Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI.
In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.
| 2152551 | ecrin-mdr-crc