CC BY-NC-ND 4.0 · Endosc Int Open 2019; 07(11): E1574-E1582
DOI: 10.1055/a-0953-1468
Original article
Owner and Copyright © Georg Thieme Verlag KG 2019

The WASh Trial: water-assisted sigmoidoscopy in the English Bowel Scope Screening Programme: study protocol for a randomized multicenter trial

Iosif Beintaris
 1   Department of Gastroenterology, University Hospital of North Tees, Stockton-On-Tees, UK
,
Shiran Esmaily
 1   Department of Gastroenterology, University Hospital of North Tees, Stockton-On-Tees, UK
,
Brian P. Saunders
 2   Wolfson Unit of Endoscopy, St Mark’s Hospital, London, UK
,
Colin J. Rees
 3   Department of Gastroenterology, South Tyneside NHS Trust, South Shields UK
,
Christian Von Wagner
 4   Research Department of Epidemiology and Public Health, University College London, UK
,
Zacharias Tsiamoulos
 2   Wolfson Unit of Endoscopy, St Mark’s Hospital, London, UK
,
Zoe Hoare
 5   North Wales Organisation for Randomised Trials in Health, UK
,
Rachel Evans
 5   North Wales Organisation for Randomised Trials in Health, UK
,
Seow Tien Yeo
 6   Centre for Health Economics and Medicines Evaluation, Bangor University, UK
,
R. T. Edwards
 6   Centre for Health Economics and Medicines Evaluation, Bangor University, UK
,
Tony Larkin
 7   10 Tulip Close, Hartlepool
,
Andrew Veitch
 8   Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
,
Andrew Chilton
 9   Department of Gastroenterology, Kettering General Hospital NHS Foundation Trust, UK
,
Michael G. Bramble
10   Department of Gastroenterology, James Cook University Hospital, Middlesbrough, UK
,
Jill Deane
 1   Department of Gastroenterology, University Hospital of North Tees, Stockton-On-Tees, UK
,
Matthew D. Rutter
 1   Department of Gastroenterology, University Hospital of North Tees, Stockton-On-Tees, UK
11   School of Medicine Pharmacy and Health, Durham University, UK
12   Northern Institute for Cancer Research, Newcastle University, UK
› Author Affiliations
Further Information

Publication History

submitted 10 October 2018

accepted after revision 23 April 2019

Publication Date:
11 November 2019 (online)

Abstract

Background and study aims The English National Bowel Scope Screening Programme (BSSP) invites 55-year-olds for a one-off, unsedated flexible sigmoidoscopy (FSIG). Data from BSSP participant-reported experience studies shows 1 in 3 participants report moderate or severe discomfort. Water-assisted colonoscopy (WAS) may improve participants’ comfort. The primary objective of this study is to ascertain if post-procedural participant-assessed pain is reduced in WAS compared with carbon dioxide (CO2) insufflation, in invitees undergoing FSIG in BSSP.

Patients and methods This is a multicenter, prospective, randomized, two-arm, single-blinded trial designed to evaluate the performance of WAS versus CO2 insufflation in BSSP. Participants will be randomized to either CO2 or WAS and will be asked to rate pain post-procedure. Key procedure-related data will be analyzed, including adenoma detection rates (ADR) and degree of sigmoid looping. A cost-effectiveness analysis of WAS versus CO2 and a discrete choice experiment exploring preferences of participants for attributes of sigmoidoscopy will also be performed.

Discussion This is the first trial in the United Kingdom (UK) to investigate the effects of WAS in a screening setting. If the trial shows WAS either reduces pain or increases ADR, this may result in a practice change to implement WAS in screening and non-screening endoscopic practice directly impacting on 256,000 people a year who will undergo BSSP FSIG by 2020.

Trial funding came from National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) supported by the NIHR Clinical Research Network. The trial is actively recruiting. ID: 35866 ISRCTN: 81466870

 
  • References

  • 1 Atkin WS, Edwards R, Kralj-Hans I. et al. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet 2010; 375: 1624-1633
  • 2 Bevan R, Rubin G, Sofianopoulou E. et al. Implementing a national flexible sigmoidoscopy screening program: results of the English early pilot. Endoscopy 2015; 47: 225-231
  • 3 Von Wagner C. Patient Experience of Bowel Cancer Screening: What are we measuring?. Liverpool, United Kingdom: British Society of Gastroenterology; 2016
  • 4 McLachlan SA, Clements A, Austoker J. Patients' experiences and reported barriers to colonoscopy in the screening context--a systematic review of the literature. Patient Educ Couns 2012; 86: 137-146
  • 5 Falchuk ZM, Griffin PH. A technique to facilitate colonoscopy in areas of severe diverticular disease. N Engl J Med 1984; 310: 598
  • 6 Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am 2013; 42: 507-519
  • 7 Leung FW, Harker JO, Jackson G. et al. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc 2010; 72: 693-700
  • 8 Leung J, Mann S, Siao-Salera R. et al. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc 2011; 73: 103-110
  • 9 Pohl J, Messer I, Behrens A. et al. Water infusion for cecal intubation increases patient tolerance, but does not improve intubation of unsedated colonoscopies. Clin Gastroenterol Hepatol 2011; 9: 1039-1043.e1031
  • 10 Ramirez FC, Leung FW. A head-to-head comparison of the water vs. air method in patients undergoing screening colonoscopy. J Interv Gastroenterol 2011; 1: 130-135
  • 11 Falt P, Liberda M, Smajstrla V. et al. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol 2012; 24: 971-977
  • 12 Leung FW, Amato A, Ell C. et al. Water-aided colonoscopy: a systematic review. Gastrointest Endosc 2012; 76: 657-666
  • 13 Amato A, Radaelli F, Paggi S. et al. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum 2013; 56: 511-518
  • 14 Falt P, Smajstrla V, Fojtik P. et al. Cap-assisted water immersion for minimal sedation colonoscopy: prospective, randomized, single-center trial. Dig Endosc 2013; 25: 434-439
  • 15 Cadoni S, Gallittu P, Sanna S. et al. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy 2014; 46: 212-218
  • 16 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; 109: 1390-1400
  • 17 Anderson JC. Water-aided colonoscopy. Gastrointest Endosc Clin N Am 2015; 25: 211-226
  • 18 Garborg K, Kaminski MF, Lindenburger W. et al. Water exchange versus carbon dioxide insufflation in unsedated colonoscopy: a multicenter randomized controlled trial. Endoscopy 2015; 47: 192-199
  • 19 Cadoni S, Falt P, Gallittu P. et al. Water exchange is the least painful colonoscope insertion technique and increases completion of unsedated colonoscopy. Clin Gastroenterol Hepatol 2015; 13: 1972-1980
  • 20 Cadoni S, Sanna S, Gallittu P. et al. 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; 81: 557-566
  • 21 UEG Week 2015 Poster Presentations. United European gastroenterology journal 2015; 3: 146-687
  • 22 Wang X, Luo H, Xiang Y. et al. Left-colon water exchange preserves the benefits of whole colon water exchange at reduced cecal intubation time conferring significant advantage in diagnostic colonoscopy - a prospective, randomized controlled trial. Scand J Gastroenterol 2015; 50: 916-923
  • 23 Rex DK. Water exchange vs. water immersion during colonoscope insertion. Am J Gastroenterol 2014; 109: 1401-1403
  • 24 Leung F, Harker J, Leung J. et al. Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score – review of randomized controlled trials (RCTs) of water method colonoscopy. J Interv Gastroenterol 2011; 1: 114-120
  • 25 Hafner S, Zolk K, Radaelli F. et al. Water infusion versus air insufflation for colonoscopy. Cochrane Database Syst Rev 2015; DOI: 10.1002/14651858.CD009863.pub2.
  • 26 Luo H, Zhang L, Liu X. et al. Water exchange enhanced cecal intubation in potentially difficult colonoscopy. Unsedated patients with prior abdominal or pelvic surgery: a prospective, randomized, controlled trial. Gastrointest Endosc 2013; 77: 767-773
  • 27 Vemulapalli KC, Rex DK. Water immersion simplifies cecal intubation in patients with redundant colons and previous incomplete colonoscopies. Gastrointest Endosc 2012; 76: 812-817
  • 28 Sugimoto S, Mizukami T. Diagnostic and therapeutic applications of water-immersion colonoscopy. World J Gastroenterol: WJG 2015; 21: 6451-6459
  • 29 Russell D, Hoare ZS, Whitaker R. et al. Generalized method for adaptive randomization in clinical trials. Stat Med 2011; 30: 922-934
  • 30 Glick H, Doshi JA, Sonnad SS. et al. Economic evaluation in clinical trials. Oxford: Oxford University Press; 2015
  • 31 Drummond MF, Sculpher MJ, Claxton K. et al. Methods for the economic evaluation of health care programmes. Fourth edition. Oxford: Oxford University Press; 2017
  • 32 Morris S, Devlin N, Parkin D. Economic analysis in health care. Chichester: John Wiley & Sons, Ltd; 2007
  • 33 Fenwick E, Marshall DA, Levy AR. et al. Using and interpreting cost-effectiveness acceptability curves: an example using data from a trial of management strategies for atrial fibrillation. BMC Health Serv Res 2006; 6: 52
  • 34 Yeo ST, Edwards RT, Fargher EA. et al. Preferences of people with diabetes for diabetic retinopathy screening: a discrete choice experiment. Diabet Med 2012; 29: 869-877
  • 35 Ryan M, Scott DA, Reeves C. et al. Eliciting public preferences for healthcare: a systematic review of techniques. Health Technol Assess 2001; 5: 1-186