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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03954561
Other study ID # A10601001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2017
Est. completion date August 14, 2018

Study information

Verified date June 2021
Source Dalin Tzu Chi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Loop formation is the most frequent cause of cecal intubation failure during colonoscopy. To reduce the loop formation, external abdominal pressure is widely used and proved to be helpful. Properly applied pressure can also decrease patients discomfort and shorten the cecal intubation time. The loop formation during water exchange is less severe as compared with during air insufflation and can be reduced quite readily. Traditionally an assistant is not asked to administer abdominal compression until the endoscopist has struggled for some time and failed to reduce the loops by withdrawal. The colonoscopist can administer the abdominal compression whenever the scope is not advancing smoothly, probably in the early stage of loop formation. We test the hypothesis that colonoscopist administered abdominal compression to remove loops in their early stage of formation hastens cecal intubation. A total of 120patients will be randomized in a 1:1 ratio (n=60 per group). When the tip of the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the scope will be implemented. If looping persists, abdominal compression will be applied. In the endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will apply the compression with his right hand and counter the pressure by pushing the back of the patient with his left forearm with the colonoscope in his left hand. The compression will be administered at left lower quadrant when the scope is in the sigmoid colon and at left lower quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or ascending colon. If the formation of loop cannot be overcome, an assistant will apply the abdominal compression instead. In the assistant-administered abdominal compression (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is formed. The assistant will apply the compression at the left lower quadrant initially, but quickly shift to other parts as needed depending on the tip location of colonoscope. If manual compressions fail, then the patients' position will be changed.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 14, 2018
Est. primary completion date August 14, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - In the Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan. - Patients who undergo WE colonoscopy performed by the two endoscopists (YHH and CWT) at the endoscopic suite will be included. Exclusion Criteria: - Included patient declined to give consent, - age <20 years old, - age >80 years old, - previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (BMI = 35).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
endoscopist-administered abdominal compression
The endoscopist administers abdominal compression when loop formation encountered.
assistant-administered abdominal compression
A assistant administers abdominal compression when loop formation encountered.

Locations

Country Name City State
Taiwan Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Chia-Yi

Sponsors (1)

Lead Sponsor Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (19)

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. Erratum in: Gastrointest Endosc. 2015 May;81(5):1303. — View Citation

Catalano F, Catanzaro R, Branciforte G, Bentivegna CF, Cipolla R, Brogna A, Sala LO, Migliore G, Paternuosto M. Colonoscopy technique with an external straightener. Gastrointest Endosc. 2000 May;51(5):600-4. — View Citation

Church JM. Ancillary colonoscope insertion techniques. An evaluation. Surg Endosc. 1993 May-Jun;7(3):191-3. — View Citation

Dechêne A, Jochum C, Bechmann LP, Windeck S, Gerken G, Canbay A, Zöpf T. Magnetic endoscopic imaging saves abdominal compression and patient pain in routine colonoscopies. J Dig Dis. 2011 Oct;12(5):364-70. doi: 10.1111/j.1751-2980.2011.00524.x. — View Citation

Herreros de Tejada A, Giménez-Alvira L, Van den Brule E, Sánchez-Yuste R, Matallanos P, Blázquez E, Calleja JL, Abreu LE. Severe splenic rupture after colorectal endoscopic submucosal dissection. World J Gastroenterol. 2014 Jul 28;20(28):9618-20. doi: 10.3748/wjg.v20.i28.9618. — View Citation

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. — View Citation

Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15. — View Citation

Hsieh YH, Tseng KC, Chou AL. Patient self-administered abdominal pressure to reduce loop formation during minimally sedated colonoscopy. Dig Dis Sci. 2010 May;55(5):1429-33. doi: 10.1007/s10620-009-0876-3. Epub 2009 Jul 7. — View Citation

Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6. — View Citation

Kudo Se, Lambert R, Allen JI, Fujii H, Fujii T, Kashida H, Matsuda T, Mori M, Saito H, Shimoda T, Tanaka S, Watanabe H, Sung JJ, Feld AD, Inadomi JM, O'Brien MJ, Lieberman DA, Ransohoff DF, Soetikno RM, Triadafilopoulos G, Zauber A, Teixeira CR, Rey JF, Jaramillo E, Rubio CA, Van Gossum A, Jung M, Vieth M, Jass JR, Hurlstone PD. Nonpolypoid neoplastic lesions of the colorectal mucosa. Gastrointest Endosc. 2008 Oct;68(4 Suppl):S3-47. doi: 10.1016/j.gie.2008.07.052. Review. — View Citation

Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. — View Citation

Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467. Review. — View Citation

Leung JW, Thai A, Yen A, Ward G, Abramyan O, Lee J, Smith B, Leung F. Magnetic endoscope imaging (ScopeGuide) elucidates the mechanism of action of the pain-alleviating impact of water exchange colonoscopy - attenuation of loop formation. J Interv Gastroenterol. 2012 Jul;2(3):142-146. Epub 2012 Jul 1. — View Citation

Rex DK, Goodwine BW. Method of colonoscopy in 42 consecutive patients presenting after prior incomplete colonoscopy. Am J Gastroenterol. 2002 May;97(5):1148-51. — View Citation

Rex DK. Water exchange vs. water immersion during colonoscope insertion. Am J Gastroenterol. 2014 Sep;109(9):1401-3. doi: 10.1038/ajg.2014.235. — View Citation

Shah SG, Brooker JC, Thapar C, Williams CB, Saunders BP. Patient pain during colonoscopy: an analysis using real-time magnetic endoscope imaging. Endoscopy. 2002 Jun;34(6):435-40. — View Citation

The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc. 2003 Dec;58(6 Suppl):S3-43. Review. — View Citation

Tsutsumi S, Fukushima H, Kuwano H. Colonoscopy using an abdominal bandage. Hepatogastroenterology. 2007 Oct-Nov;54(79):1983-4. — View Citation

Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary cecal intubation time the time when the colonoscope is inserted from the anus to the cecum. through study completion, average 15 minutes
Secondary proportion of patients requiring abdominal compression by an assistant proportion of patients requiring abdominal compression by an assistant through study completion, average 15 minutes
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