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| Name | Class |
|---|---|
| VA Northern California Health Care System | FED |
| VA Palo Alto Health Care System | FED |
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This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful.
Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.
Control Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.
Study method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Method | Other | One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. |
|
| Study Method | Other | The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| Real Time Maximum Insertion Pain | Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior. | Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With No Insertion Pain | Proportion of patients who report no pain during insertion of the colonoscope. | Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
| Insertion Time |
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Inclusion Criteria:
Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:
Exclusion Criteria:
decline to be randomized
unable to give consent or respond to questionnaires
history of colon surgery
active inflammatory bowel disease
lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)
therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
proctosigmoidoscopy
bidirectional endoscopy
inadequate consumption of bowel preparation
known history of severe diverticulosis or diverticulitis
history of abdominal surgery previously requiring sedation for colonoscopy
current narcotic/anxiolytic medication use
prior unsuccessful experience with unsedated colonoscopy
emergent colonoscopy
evidence of colonic obstruction based on pre-colonoscopy clinical evaluation
current participation in other studies
medical condition that could increase the risk associated with colonoscopy
medical condition that would preclude a benefit from colonoscopic screening
prosthetic heart valve
anticoagulant therapy
nonmedical problems
need for special precautions in performing colonoscopy
request of on demand sedation
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| Name | Affiliation | Role |
|---|---|---|
| Felix W. Leung, MD | VA Greater Los Angeles Healthcare System, Sepulveda, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States | ||
| VA Northern California Health Care System, Mather, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4682941 | Background | Wolff WI, Shinya H. Polypectomy via the fiberoptic colonoscope. Removal of neoplasms beyond reach of the sigmoidoscope. N Engl J Med. 1973 Feb 15;288(7):329-32. doi: 10.1056/NEJM197302152880701. No abstract available. | |
| 19249764 | Background | Leung FW. The case of unsedated screening colonoscopy in the United States. Gastrointest Endosc. 2009 Jun;69(7):1354-6. doi: 10.1016/j.gie.2008.12.234. Epub 2009 Feb 27. No abstract available. |
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Subjects will be selected from patients scheduled for colonoscopy as part of their routine care. Eligible subjects will be asked to sign the ICF. Control and study methods will be explained, and study subjects will undergo a questionnaire, physical examination, and unsedated colonoscopy with the standard (control) or study methods. Ineligible patients will be offered unsedated colonoscopy by standard method, outside the research study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Method | One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion. |
| FG001 | Study Method | The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients were US veterans scheduled for routine colonoscopy as part of their standard of care.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Method | One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Male and female veterans aged 50-80, inclusive. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Real Time Maximum Insertion Pain | Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior. | Posted | Mean | Standard Deviation | score on a scale | Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
|
Adverse events and serious adverse event, were monitored for the total duration of the study, which was up to 30 days.
Our definition of Adverse or Serious Adverse Events does not differ from the clinicaltrials.gov definitions.
All colonoscopy procedures were routinely performed by gastroenterologists with at least 5 years of experience.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Method | One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion. |
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The limitations included: (1) subjects were mostly male Veterans, (2) colonoscopists were unblinded, (3) colonoscopist-assessed patient anxiety was subjective and not measured on a standardized anxiety scale.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felix W. Leung, M.D, Staff Gastroenterologist | Veterans Administration Greater Los Angeles Healthcare System | 818-891-7711 | 32520 | felix.leung@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2017 | Oct 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2017 | Oct 12, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2019 | Oct 2, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| C537774 | Anterior polar cataract 2 |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site. Control Method: Involves unsedated colonoscopy with water exchange. Residual air will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.
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|
| Study method | Device | Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. |
|
|
Time to cecum (clock display on monitor), faster insertion is a quality marker |
| Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
| Right Colon Adenoma Detection Rate (ADR) | Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure. | Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
| Sacramento |
| California |
| 95655 |
| United States |
| VA Greater Los Angeles Healthcare System, Sepulveda, CA | Sepulveda | California | 91343 | United States |
| 21160707 | Background | Leung FW, Aljebreen AM, Brocchi E, Chang EB, Liao WC, Mizukami T, Schapiro M, Triantafyllou K. Sedation-risk-free colonoscopy for minimizing the burden of colorectal cancer screening. World J Gastrointest Endosc. 2010 Mar 16;2(3):81-9. doi: 10.4253/wjge.v2.i3.81. |
| 21686108 | Background | Leung FW. Is there a place for sedationless colonoscopy? J Interv Gastroenterol. 2011 Jan;1(1):19-22. doi: 10.4161/jig.1.1.14592. |
| 8603544 | Background | Cataldo PA. Colonoscopy without sedation. Dis Colon Rectum. 1996 Mar;39(3):257-61. doi: 10.1007/BF02049463. |
| 9649011 | Background | Hoffman MS, Butler TW, Shaver T. Colonoscopy without sedation. J Clin Gastroenterol. 1998 Jun;26(4):279-82. doi: 10.1097/00004836-199806000-00013. |
| 10228251 | Background | Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc. 1999 May;49(5):554-9. doi: 10.1016/s0016-5107(99)70381-0. |
| 15942439 | Background | Subramanian S, Liangpunsakul S, Rex DK. Preprocedure patient values regarding sedation for colonoscopy. J Clin Gastroenterol. 2005 Jul;39(6):516-9. doi: 10.1097/01.mcg.0000165667.79530.44. |
| 10406249 | Background | Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol. 1999 Jul;94(7):1862-5. doi: 10.1111/j.1572-0241.1999.01219.x. |
| 21686115 | Background | Leung FW. Patients' perspective - written testimonials from physician-patients and oral accounts presented by patients in person. J Interv Gastroenterol. 2011 Jan;1(1):45-46. doi: 10.4161/jig.1.1.14605. No abstract available. |
| 17608779 | Background | Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007 Nov;102(11):2401-10. doi: 10.1111/j.1572-0241.2007.01387.x. Epub 2007 Jun 29. |
| 18274901 | Background | Leung FW. Unsedated colonoscopy introduced to ensure access is acceptable to a subgroup of veterans. Dig Dis Sci. 2008 Oct;53(10):2719-22. doi: 10.1007/s10620-007-0192-8. Epub 2008 Feb 15. |
| Background | Felix W. Leung, Hartley Cohen, Stanley K. Dea, Dennis M. Jensen, Thomas O. Kovacs, Gordon V. Ohning, Joseph R. Pisegna, Alireza Sedarat, Alan Sheinbaum, Timothy C. Simmons, Rebecca Slomovic, Brennan M. Spiegel, Mitchell J. Spirt, James Sul and Rabindra R. Watson. Scheduled unsedated colonoscopy - a novel tool for managing no shows due to lack of escorts required for conscious sedation. Gastrointestinal Endoscopy, 2014-05-01, Volume 79, Issue 5, Pages AB178-AB179 |
| 11474385 | Background | Terruzzi V, Meucci G, Radaelli F, Terreni N, Minoli G. Routine versus "on demand" sedation and analgesia for colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2001 Aug;54(2):169-74. doi: 10.1067/mge.2001.113923. |
| 20619405 | Background | Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8. |
| Background | Leung JW, Mann SK, Siao-Salera R, Canete W, Leung FW. The established and time-tested water exchange method in scheduled unsedated colonoscopy significantly enhanced patient-centered outcomes without prolonging procedural times - A RCT. J Interv Gastroenterol. 2013;3(1):7-11. |
| 24890443 | Background | Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3. |
| 24218307 | Background | Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11. |
| 25262100 | Background | Cadoni S, Sanna S, Gallittu P, Argiolas M, Fanari V, Porcedda ML, Erriu M, Leung FW. A randomized, controlled trial comparing real-time insertion pain during colonoscopy confirmed water exchange to be superior to water immersion in enhancing patient comfort. Gastrointest Endosc. 2015 Mar;81(3):557-66. doi: 10.1016/j.gie.2014.07.029. Epub 2014 Sep 26. |
| 25956838 | Background | Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5. |
| 27744665 | Background | Kim HG. Painless Colonoscopy: Available Techniques and Instruments. Clin Endosc. 2016 Sep;49(5):444-448. doi: 10.5946/ce.2016.132. Epub 2016 Sep 30. |
| 23235654 | Background | Morgan J, Thomas K, Lee-Robichaud H, Nelson RL, Braungart S. Transparent cap colonoscopy versus standard colonoscopy to improve caecal intubation. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD008211. doi: 10.1002/14651858.CD008211.pub3. |
| 23884794 | Background | Holme O, Bretthauer M, de Lange T, Seip B, Huppertz-Hauss G, Hoie O, Sandvei P, Ystrom CM, Hoff G. Risk stratification to predict pain during unsedated colonoscopy: results of a multicenter cohort study. Endoscopy. 2013 Sep;45(9):691-6. doi: 10.1055/s-0033-1344239. Epub 2013 Jul 24. |
| 33725848 | Background | Wang L, Jia H, Luo H, Kang X, Zhang L, Wang X, Yao S, Tao Q, Pan Y, Guo X. A novel intubation discomfort score to predict painful unsedated colonoscopy. Medicine (Baltimore). 2021 Mar 12;100(10):e24907. doi: 10.1097/MD.0000000000024907. |
| 11051348 | Background | Anderson JC, Gonzalez JD, Messina CR, Pollack BJ. Factors that predict incomplete colonoscopy: thinner is not always better. Am J Gastroenterol. 2000 Oct;95(10):2784-7. doi: 10.1111/j.1572-0241.2000.03186.x. |
| 39053653 | Derived | Leung FW, Cheung R, Friedland S, Jacob N, Leung JW, Pan JY, Quan SY, Sul J, Yen AW, Jamgotchian N, Chen Y, Dixit V, Shaikh A, Elashoff D, Saha A, Wilhalme H. Prospective randomized controlled trial of water exchange plus cap versus water exchange colonoscopy in unsedated veterans. Gastrointest Endosc. 2025 Feb;101(2):402-413.e2. doi: 10.1016/j.gie.2024.07.010. Epub 2024 Jul 23. |
| BG001 | Study Method | The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | All enrolled participants were United States Veterans | Count of Participants | Participants |
|
| OG001 | Study Method | The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. |
|
|
|
| Secondary | Proportion of Patients With No Insertion Pain | Proportion of patients who report no pain during insertion of the colonoscope. | Posted | Count of Participants | Participants | Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
|
|
|
| Secondary | Insertion Time | Time to cecum (clock display on monitor), faster insertion is a quality marker | Posted | Mean | Standard Deviation | Minutes | Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
|
|
|
| Secondary | Right Colon Adenoma Detection Rate (ADR) | Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure. | Posted | Count of Participants | Participants | Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour |
|
|
|
| 0 |
| 137 |
| 0 |
| 137 |
| 0 |
| 137 |
| EG001 | Study Method | The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion. Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. | 0 | 143 | 0 | 143 | 0 | 143 |
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