Intervention Protocol

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Intravenous hyoscine-N-butyl bromide for aiding colonoscopy

  1. Steven R Brown1,
  2. Wal Baraza2,*

Editorial Group: Cochrane Colorectal Cancer Group

Published Online: 29 OCT 2013

DOI: 10.1002/14651858.CD010809


How to Cite

Brown SR, Baraza W. Intravenous hyoscine-N-butyl bromide for aiding colonoscopy (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD010809. DOI: 10.1002/14651858.CD010809.

Author Information

  1. 1

    Sheffield Teaching Hospitals, Surgery, Sheffield S7, South Yorkshire, UK

  2. 2

    NHS, Colorectal Surgery, Sheffield, Yorkshire, UK

*Wal Baraza, Colorectal Surgery, NHS, 59 Ryegate Road Sheffield, Sheffield, Yorkshire, S10 5FB, UK. walbaraza@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 29 OCT 2013

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Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Description of the condition

Colonoscopy is increasingly used for the detection and surveillance of colorectal conditions. It is particularly important in the secondary prevention of colorectal cancer by detecting polyps which are thought to undergo malignant change with time if left untreated (Morson 1971). It is important for the entire colorectum to be visualised from the anal margin to the caecal pole in order to reduce the likelihood of missed polyps. The intrinsic nature of the bowel with its tortuous course and differences in anatomical mobility can make colonoscopy difficult for both patient and practitioner. It can be an uncomfortable procedure for patients as the endoscope and gas insufflation stretch the bowel wall and put tension on the colonic mesentery (Hull 1994; Takahashi 2005). Patient discomfort is more pronounced during insertion of the colonoscope due to the formation of loops within the mobile segments of the colon, usually the sigmoid and transverse segments (Cotton 2008; Shah 2002). Techniques that would aid the passage of the colonoscope may improve patient comfort, speed up the intubation process and improve caecal intubation rates.

 

Description of the intervention

Hyoscine-N-butylbromide (scopolamine, Buscopan® (Boehringer Ingelheim, Germany)), is an antispasmodic drug derived from the plant genus Duboisia first licensed in the 1950s. It is a rapid-acting cholinergic muscarinic antagonist. Its duration of action when administered intravenously is about 20 minutes and its common side effects include tachycardia, blurred vision and xerostomia. It is used variably by colonoscopists and radiologists to reduce bowel spasm during colonoscopy and colonography (Elphick 2009; Goei 2000; Yoshikawa 2006).

 

How the intervention might work

The role of intravenous hyoscine-N-butylbromide (IVH) in colonoscopy is poorly defined and we aim to examine the literature on the subject with the aim of defining its usefulness with regards to expediting colonoscope passage and improving the detection of polyps. Investigators have suggested that IVH relaxes colonic smooth muscle hence allowing easier passage of the colonoscope (Saunders 1996), but this has been disputed in other studies (de Brouwer 2012; Mui 2004; Yoong 2004). The time to achieve caecal intubation can be used as a measure of this parameter. Given the indications for colonoscopy and its potential discomfort to patients, secondary outcomes measured will be polyp detection rate, degree of patient discomfort and the degree of colonic spasm.

 

Why it is important to do this review

Colonoscopy is a commonly performed intervention that can be uncomfortable for patients and IVH is variably used by endoscopists. Expediency and safety may be aided by IVH and this review aims to explore the evidence behind its use quickly and safely. Furthermore, reduction of colonic spasm may aid mucosal visualisation and hence polyp detection.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

The primary objective will be to ascertain the effects of IVH on the time taken to intubate the caecum and on patient discomfort. Secondarily, we will examine the effects of IVH on polyp detection and miss rates and drug side effects (tachycardia/blurred vision/xerostomia).

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Criteria for considering studies for this review

 

Types of studies

We will consider studies in which participants have been prospectively randomised to receive IVH during colonoscopy.

 

Inclusion criteria

  • Randomised controlled trials (RCTs) comparing IVH with no treatment

 

Exclusion criteria

  • Non-randomised studies
  • Studies comparing IVH with another modality

 

Types of participants

Adult patients undergoing complete colonoscopy and receiving IVH.

 

Types of interventions

We will consider patients receiving IVH on colonic intubation and undergoing complete colonoscopy. Patients who have incomplete colonoscopy, flexible sigmoidoscopy or colonography will be excluded.

 

Types of outcome measures

 

Primary outcomes

Time to intubate the caecum.

Patient-reported measurements of discomfort

 

Secondary outcomes

Polyp detection rates

Polyp miss rates

Observed colonic spasm is measured in various publications as:

  • on an arbitrary scale by the investigators e.g. 0, 1, 2; or
  • as a function of the area of colon visualised before and after intervention as measured by digital imaging (Ai 2006; Lee 2009; Lee 2010).

Adverse events

 

Search methods for identification of studies

 

Electronic searches

We will search the following databases to identify all published randomised controlled trials with no language restrictions:

  • Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library) (Appendix 1);
  • MEDLINE from 1966 to date (Ovid) (Appendix 1);
  • EMBASE from 1980 to date (Ovid) (Appendix 1);
  • SCOPUS

We will use the free-text and MeSH terms "hyoscine", "hyoscine-N-butylbromide", "buscopan", "scopolamine", "antispasmodic" and "colonoscopy". 

Furthermore, we will search meeting abstracts from the British Society of Gastroenterologists, the Association of Surgeons of Great Britain and Ireland, the Association of Coloproctologists of Great Britain and Ireland, tthe European Society of Coloproctology, the American Society of Colon and Rectal Surgeons, the American College of Gastroenterology and the United European Gastroenterology meeting. Digestive Diseases Week (DDW) and the Canadian DDW will also be searched. We will also screen the references lists of these articles to find further relevant studies.

 

Searching other resources

We will search web-based registers of RCTs such as Current Controlled Trials (http://www.controlled-trials.com/) and ClinicalTrials.gov (http://clinicaltrials.gov/). . We will handsearch published meeting proceedings and supplements from endoscopy, colorectal and gastroenterology journals.

 

Data collection and analysis

 

Selection of studies

The two authors (SRB, WB) will assess the search results and determine inclusion/exclusion decisions independently for each identified relevant study. Any disagreements will be resolved by consensus.

 

Data extraction and management

The two authors (SRB, WB) will independently extract data from all the relevant studies. Extracted data will be cross-checked with any discrepancies resolved by discussion. Data will be obtained from the cited text, tables and figures with the necessary extrapolations performed (e.g. converting standard errors to standard deviations).

 

Assessment of risk of bias in included studies

The two authors (SRB, WB) will assess the risk of bias of eligible studies independently, taking into account the processes of sequence generation, allocation concealment, attrition , selective reporting, blinding of the endoscopists, patients and nursing staff to the intervention. Bias will be assessed as per the guidance from the Cochrane Collaboration's tool for assessing risk of bias (Higgins 2011). Other potential causes of bias will also be examined. T

 

Unit of analysis issues

Any issues relating to the analysis of data which do not take account of the design of the study (for example crossover or cluster designs) will be addressed on a study by study in accordance with guidance outlined in The Cochrane Handbook (Higgins 2011).

 

Dealing with missing data

Attempts will be made to contact authors for raw and missing data based on the results of the search for published papers and abstracts.

 

Assessment of heterogeneity

Heterogeneity will be assessed using the I2 measurement (Higgins 2011). We will consider the potential sources of heterogeneity

 

Assessment of reporting biases

We will analyse both published and unpublished data and include the findings in the review as appropriate.

 

Data synthesis

We will analyse data using the Cochrane Collaboration's statistical software, RevMan

We will calculate odds ratios (ORs) and 95% confidence intervals (CIs) for dichotomous outcomes using the fixed-effect Mantel-Haenszel method (Higgins 2011). We will analyse continuous variables using a fixed-effect meta-analysis of weighted mean differences (WMDs). The fixed-effect model will be used . We will analyse continuous variables using means and standard deviations. When only means and ranges are available an estimate of the standard deviation will be calculated from the range.

 

Subgroup analysis and investigation of heterogeneity

We will perform a subgroup analysis if there appears to be a group of trials that match the inclusion criteria but have differing characteristics that may be relevant;

  • Study design: multi-centre vs. single-centre
  • Study population: general population vs. those at high risk of polyp detection
  • Concomitant drug therapy: e.g. IVH vs. placebo, or IVH vs. topical water
  • Concomitant endoscopic therapy: polypectomy
  • Time taken to extubate the colon
  • Polyp detection: heterogeneity may be caused by the time taken to extubate the colon, the use of chromoendoscopy
  • Patient discomfort and colonic spasm: heterogeneity may be caused by the use of different outcome measures or pain measuring scores

 

Sensitivity analysis

We will perform a sensitivity analysis to test the effect of systematically removing less robust studies or studies at high risk of bias to assess the effect on the results. Studies that differ significantly from the main body of evidence may be excluded.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

None.

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Appendix 1. Search strategies

 

CENTRAL (The Cochrane Central Register of Controlled Trials) 05.03.13 – 27 hits

1. MeSH descriptor: [Butylscopolammonium Bromide] explode all trees

2. Buscopan or Hyoscine or Buscolysin or Scopolan or Buscapine or Scopolamine or Hyoscine-N-butylbromide or Butylscopolam* or Butylhyoscine or N-butyl bromide or Scopolaminebutylbromide or Hyoscinbutylbromide or antispasm*:ti,ab,kw

3. (#1 or #2)

4. MeSH descriptor: [Colonoscopy] explode all trees

5. MeSH descriptor: [Colonoscopes] explode all trees

6. colonoscop*:ti,ab,kw

7. (#4 or #5 or #6)

8. (#3 and #7)

 

MEDLINE (Ovid) 05.03.13 – 25 hits

1. exp Butylscopolammonium Bromide/

2. (Buscopan or Hyoscine or Buscolysin or Scopolan or Buscapine or Scopolamine or Hyoscine-N-butylbromide or Butylscopolam* or Butylhyoscine or N-butyl bromide or Scopolaminebutylbromide or Hyoscinbutylbromide or antispasm*).mp.

3. 1 or 2

4. exp Colonoscopy/

5. Colonoscopes/

6. colonoscop*.mp.

7. 4 or 5 or 6

8. 3 and 7

9. randomized controlled trial.pt.

10. controlled clinical trial.pt.

11. randomized.ab.

12. placebo.ab.

13. clinical trial.sh.

14. randomly.ab.

15. trial.ti.

16. 9 or 10 or 11 or 12 or 13 or 14 or 15

17. humans.sh.

18. 16 and 17

19. 8 and 18

 

EMBASE (Ovid) 05.03.13 – 102 hits

1. exp scopolamine butyl bromide/

2. (Buscopan or Hyoscine or Buscolysin or Scopolan or Buscapine or Scopolamine or Hyoscine-N-butylbromide or Butylscopolam* or Butylhyoscine or N-butyl bromide or Scopolaminebutylbromide or Hyoscinbutylbromide or antispasm*).mp.

3. 1 or 2

4. exp colonoscopy/

5. exp colonoscope/

6. colonoscop*.mp.

7. 4 or 5 or 6

8. 3 and 7

9. randomized controlled trial/

10. randomization/

11. controlled study/

12. multicenter study/

13. phase 3 clinical trial/

14. phase 4 clinical trial/

15. double blind procedure/

16. single blind procedure/

17. ((singl* or doubl* or trebl* or tripl*) adj (blind* or mask*)).ti,ab.

18. (random* or cross* over* or factorial* or placebo* or volunteer*).ti,ab.

19. 14 or 11 or 15 or 17 or 10 or 16 or 12 or 9 or 18 or 13

20. "human*".ti,ab.

21. (animal* or nonhuman*).ti,ab.

22. 21 and 20

23. 21 not 22

24. 19 not 23

25. 8 and 24

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

Both authors contributed to the development of this protocol. For the review, both SRB and WB will independently perform electronic searches. WB will perform the handsearching of meeting abstracts, web-based database and contact authors for missing or raw data. The inclusion of disputed studies will be resolved by mutual consensus. Both authors will independently extract data from studies, assess studies for their risk of bias, and enter data into Review Manager 2013. Both authors will contribute equally to the writing of the review.

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

The authors declare no conflict of interest.

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Internal sources

  • Henning Andersen, Denmark.
  • Marija Barbeteskovic, Denmark.

 

External sources

  • No sources of support supplied

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. Appendices
  8. Contributions of authors
  9. Declarations of interest
  10. Sources of support
  11. Additional references
Ai 2006
  • Ai M, Yamaguchi T, Odaka T, Mitsuhashi K, Shishido T, Yan J, et al. Objective assessment of the antispasmodic effect of shakuyaku-kanzo-to (TJ-68), a Chinese herbal medicine, on the colonic wall by direct spraying during colonoscopy. World Journal of Gastroenterology 2006;12(5):760-4.
Cotton 2008
  • Cotton PB, Williams CB, Hawes RH, Saunders BP. Practical Gastrointestinal Endoscopy: The Fundamentals. 6th Edition. Wiley-Blackwell, 2008.
de Brouwer 2012
  • de Brouwer EJ, Arbouw ME, van der Zwet WC, van Herwaarden MA, Ledeboer M, Jansman FG, et al. Hyoscine N-butylbromide does not improve polyp detection during colonoscopy: a double-blind, randomized, placebo-controlled, clinical trial. Gastrointestinal Endoscopy 2012;75(4):835-40.
Elphick 2009
  • Elphick DA, Donnelly MT, Smith KS, Riley SA. Factors associated with abdominal discomfort during colonoscopy: a prospective analysis. European Journal of Gastroenterology and Hepatology 2009;21(9):1076-82.
Goei 2000
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Higgins 2011
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Hull 1994
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Lee 2009
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Lee 2010
  • Lee JM, Cheon JH, Park JJ, Moon CM, Kim ES, Kim TI, et al. Effects of Hyosine N-butyl bromide on the detection of polyps during colonoscopy. Hepatogastroenterology 2010;57(97):90-4.
Morson 1971
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Saunders 1996
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Shah 2002
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Takahashi 2005
  • Takahashi Y, Tanaka H, Kinjo M, Sakumoto K. Prospective evaluation of factors predicting difficulty and pain during sedation-free colonoscopy. Diseases of the Colon and Rectum 2005;48(6):1295-300.
Yoong 2004
  • Yoong KY, Perkin D, Portal J, Strickland I, Heymann T. Intravenous hyoscine as a premedication for colonoscopy: a randomised double-blind controlled trial. Endoscopy 2004;36(8):720-2.
Yoshikawa 2006
  • Yoshikawa I, Yamasaki M, Taguchi M, Kanda K, Tashiro M, Kume K, et al. Comparison of glucagon and scopolamine butylbromide as premedication for colonoscopy in unsedated patients. Diseases of the Colon and Rectum 2006;49(9):1393-8.