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A randomised controlled study evaluating the use of water during a colonoscopy in patients to facilitate the performance of the colonoscopic procedure

ABSTRACT: Interventions: The use of room temperature water as an adjunctive method for distension of colon lumen during colonoscopy. Approximately 300ml of sterile water will be instilled into the colon during the colonoscopy procedure. The addition of water will take approximately 2-3 minutes to the overall time of the procedure. Additional gas insufflation (the normal standard of care) will also be used in addition to the water to achieve adequate colon distension to facilitate the procedure. Patients will be randomised to either the water assisted group or the standard of care. patients will be blinded to which arm they have been allocated to, but the operator will be unblinded. Standard parameters will be monitored and recorded during the procedure in both arms to assess the effect/difference between the two groups Primary outcome(s): Time to caecal intubation[When the caecal pole is reached];Patient analgesic scores. Pain will be assessed by using a visual analog scale of 1-10 (Wong-Baker Faces Pain rating scale) [At conclusion of procedure and if further analgesia is requested by the patient during the procedure.];Sedation requirements. The required quantity of midazolam and fentanyl will be collated and recorded at the conclusion of the procedure. Any extra analgesia during the course of the procedure will be noted in addition to the induction analgesia. [At conclusion of the procedure] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Screening Intervention For Colorectal Cancer Prevention,Investigation For Patients With Lower Gastrointestinal Symptoms Such As Rectal Bleeding, Altered Bowel Habit And Abdominal Pain

PROVIDER: 2460388 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: WAC intervention, Colonoscopist use water to inflate the colon instead of air during insertion the colonoscope. The sterile water at room temperature is pumped into the system. Patient demographics, which are age, sex, weight, height, and waist circumference are recorded prior to a colonoscopy procedure. Vital sign is measured in all patients, that are blood pressure, heart rate and oxygen saturation. Prior to a colonoscopy procedure, the patient is positioned on their left side, and a transparent cap is attached to the tip of the colonoscope. In addition, all patients are typically administered 2 mg of midazolam intravenously for sedation during the procedure. Once the colonoscope is inserted, the air pump is turned off. Cecal intubation time is recorded when colonoscopist reach to the cecal floor, appendix orifice and the opening of terminal ilium. These landmark is indicators of a successful intubation of the entire colon. To evaluate the level of pain experienced by the patient during a colonoscopy procedure, a 10-points scale is used. This scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain. During the procedure, the nurse will ask the patient to provide their pain score every 3 minutes using the visual analog scale. If patient's pain score is greater than 3 or if the patient requests it, intravenous fentanyl (25 mcg) is administered to provide pain control. Vital sign is measured every 5 minutes during colonoscopy. During the withdrawal phase of colonoscopy procedure, air can be used to inflate the colon as usual. The time elapsed since reaching the cecal floor and the anus is recorded, and the timer is stopped when any procedure interventions, such as polypectomy or tis;Experimental Procedure/Surgery,Active Comparator Procedure/Surgery;Water-assisted colonoscopy,Carbon dioxide insufflation colonoscopy Primary outcome(s): The difficulty technique of colonoscopy between water-assisted colonoscopy and carbon dioxide colonoscopy in beginner 2 months after the end of intervention Cecal intubation time Study Design: Randomized

Project description:Intra-operative colonoscopy (inserting a flexible endoscope with a camera at its tip through the anus and up into the rectum and colon) is most often indicated to locate or verify the location of small cancer, polyp, bleeding site, or simply to inspect the bowel after the two ends have been rejoined together. Usually colonoscopy utilizes ambient air to expand and inflate the colon and, as a result, leaves the colon bloated or distended until the gas is either expelled or absorbed. This endoscopy related bowel distension is problematic in the setting of both traditional open (big incision) colorectal surgery and after minimally invasive (laparoscopic assisted) procedures. In the case of the former, it may prove difficult to close a traditional laparotomy incision if the bowel is distended and may hinder respiration with the abdomen closed. In the setting of a laparoscopic procedure, the bowel distension limits the working space available to the surgeon. Since the laparoscopic domain is limited, a distended colon following intra-operative colonoscopy can prevent the minimally invasive completion of a case (meaning that a conversion to traditional "open" methods would be necessary) that otherwise was going well with good prospects of laparoscopic completion. Colonic distension also causes abdominal pain and lengthens the recovery time from the procedure. The investigators believe that the use of CO2 during intra-operative colonoscopy or sigmoidoscopy (exam of only the last 2 to 2 ½ feet of the colon) will not cause long lasting bloating or distension of the colon as opposed to air. Carbon dioxide is absorbed 250 times faster than ambient air and may decrease after procedure colonic distension. This prospective, randomized study will compare the two gases in terms of colonic distension. Patients undergoing open or minimally invasive colorectal resection will be randomized to undergo intra-operative colonoscopy using one of the two gases. Direct measurements of colon diameter will be taken at specific time intervals after the colonoscopy.

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A randomised controlled study evaluating the use of water during a colonoscopy in patients to facilitate the performance of the colonoscopic procedure

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