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出境医 / 临床实验 / Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Colonic Polyp Colonic Adenoma Procedure: endoscopist-administered abdominal compression Procedure: assistant-administered abdominal compression Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Abdominal Compression Administered Early by the Colonoscopist Shortened Insertion Time of Water Exchange Colonoscopy
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: endoscopist group
endoscopist-administered abdominal compression group
 Procedure: endoscopist-administered abdominal compression
The endoscopist administers abdominal compression when loop formation encountered.
Active Comparator: assistant group
assistant-administered abdominal compression group
 Procedure: assistant-administered abdominal compression
A assistant administers abdominal compression when loop formation encountered.
Outcome Measures
Primary Outcome Measures :
  1. cecal intubation time [ Time Frame: through study completion, average 15 minutes ]
    the time when the colonoscope is inserted from the anus to the cecum.


Secondary Outcome Measures :
  1. proportion of patients requiring abdominal compression by an assistant [ Time Frame: through study completion, average 15 minutes ]
    proportion of patients requiring abdominal compression by an assistant


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Locations
Layout table for location information
Taiwan
Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chia-Yi, Taiwan, 622
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yu-Hsi Hsieh, MD Buddhist Dalin Tzu Chi Hospital
Tracking Information
First Submitted Date  ICMJE June 10, 2017
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE May 30, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		cecal intubation time [ Time Frame: through study completion, average 15 minutes ]
the time when the colonoscope is inserted from the anus to the cecum.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		proportion of patients requiring abdominal compression by an assistant [ Time Frame: through study completion, average 15 minutes ]
proportion of patients requiring abdominal compression by an assistant
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy
Official Title  ICMJE Abdominal Compression Administered Early by the Colonoscopist Shortened Insertion Time of Water Exchange Colonoscopy
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Colonic Polyp
  • Colonic Adenoma
Intervention  ICMJE
  • Procedure: endoscopist-administered abdominal compression
    The endoscopist administers abdominal compression when loop formation encountered.
  • Procedure: assistant-administered abdominal compression
    A assistant administers abdominal compression when loop formation encountered.
Study Arms  ICMJE
  • Experimental: endoscopist group
    endoscopist-administered abdominal compression group
    Intervention: Procedure: endoscopist-administered abdominal compression
  • Active Comparator: assistant group
    assistant-administered abdominal compression group
    Intervention: Procedure: assistant-administered abdominal compression
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • Church JM. Ancillary colonoscope insertion techniques. An evaluation. Surg Endosc. 1993 May-Jun;7(3):191-3.
  • 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.
  • Tsutsumi S, Fukushima H, Kuwano H. Colonoscopy using an abdominal bandage. Hepatogastroenterology. 2007 Oct-Nov;54(79):1983-4.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 16, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954561
Other Study ID Numbers  ICMJE A10601001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
Study Sponsor  ICMJE Dalin Tzu Chi General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yu-Hsi Hsieh, MD Buddhist Dalin Tzu Chi Hospital
PRS Account Dalin Tzu Chi General Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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