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Fecal Incontinence: The Quality of Reported Randomized, Controlled Trials in the Last Ten Years

  • Original Contribution
  • Published:
Diseases of the Colon & Rectum

Abstract

Purpose

This study was designed to analyze the characteristics and the quality of reporting of randomized, controlled trials published during the last ten years on fecal incontinence.

Methods

An electronic search for all randomized, controlled trials on fecal incontinence was undertaken by using the MEDLINE database via PubMed. The data collected were divided into general data, characteristics of reporting, methodology quality assessment using the Jadad scale and a validated methodology quality score (MINCIR score), evaluation of the items published in the CONSORT statement, and the journal impact factor. Reports were divided into two groups: published articles from 1996 to 2000 (Group 1), and from 2001 to 2005 (Group 2).

Results

Forty-two trials fulfilled the inclusion criteria of the study (Group 1, n = 15; and Group 2, n = 27). There were no significant differences in general characteristics of randomized, controlled trials between the two groups. In Group 2, there were a statistically significant higher number of studies that reported a flow chart (P < 0.001), written informed consent (P = 0.008), sample size calculation (P = 0.023), and withdrawals and dropouts (P < 0.001). We found a statistically significant higher score in Jadad scale (P = 0.046) and MINCIR score (P = 0.016) in the published studies in Group 2. Also we found higher journal impact factor of journals that published these randomized, controlled trials during the most recent years (P = 0.04).

Conclusions

There is a lack of high-quality reported randomized, controlled trials on fecal incontinence during the last ten years. Reports of randomized, controlled trials involving patients with fecal incontinence published after 2001 were better reported than in the previous five years.

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Author information

Authors and Affiliations

  1. Department of Physiology, St. Mark’s Hospital, Watford Road, Harrow, HA1 3UJ, London, United Kingdom

    David Parés M.D., Ph.D. & Christine Norton Ph.D., M.A., R.N.

  2. Burdett Institute of Gastrointestinal Nursing, King’s College London, London, United Kingdom

    Christine Norton Ph.D., M.A., R.N. & Sonya Chelvanayagam M.Sc., R.N.

Authors
  1. David Parés M.D., Ph.D.
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  2. Christine Norton Ph.D., M.A., R.N.
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  3. Sonya Chelvanayagam M.Sc., R.N.
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Corresponding author

Correspondence to Christine Norton Ph.D., M.A., R.N..

Additional information

Dr. Parés was funded by a fellowship from the Asociación Española de Cirujanos.

Appendix

Appendix

Articles Included in the Study

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4. van Tets WF, Kuijpers JH. Pelvic floor procedures produce no consistent changes in anatomy or physiology. Dis Colon Rectum 1998; 41:365–369.

5. Fynes MM, Marshall K, Cassidy M, Behan M, Walsh D, O’Connell PR, O’Herlihy C. A prospective, randomized study comparing the effect of augmented biofeedback with sensory biofeedback alone on fecal incontinence after obstetric trauma. Dis Colon Rectum 1999; 42:753–758.

6. Siproudhis L, Bellissant E, Pagenault M, Mendler MH, Allain H, Bretagne JF, Gosselin M. Fecal incontinence with normal anal canal pressures: where is the pitfall? Am J Gastroenterol 1999; 94:1556–1563.

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8. Yoshioka K, Ogunbiyi OA, Keighley MR. A pilot study of total pelvic floor repair or gluteus maximus transposition for postobstetric neuropathic fecal incontinence. Dis Colon Rectum 1999; 42:252–257.

9. Caplan GA, Ward JA, Brennan NJ, Coconis J, Board N, Brown A. Hospital in the home: a randomised controlled trial. Med J Aust 1999; 170:156–160.

10. Ho YH, Cheong WK, Tsang C, Ho J, Eu KW, Tang CL, Seow-Choen F. Stapled hemorrhoidectomy-cost and effectiveness. Randomized, controlled trial including incontinence scoring, anorectal manometry, and endoanal ultrasound assessments at up to three months. Dis Colon Rectum 2000; 43:1666–1675.

11. Fitzpatrick M, Behan M, O’Connell PR, O’Herlihy C. A randomized clinical trial comparing primary overlap with approximation repair of third-degree obstetric tears. Am J Obstet Gynecol 2000; 183:1220–1224.

12. Carapeti EA, Kamm MA, Nicholls RJ, Phillips RK. Randomized, controlled trial of topical phenylephrine for fecal incontinence in patients after ileoanal pouch construction. Dis Colon Rectum 2000; 43:1059–1063.

13. Hasegawa H, Yoshioka K, Keighley MR. Randomized trial of fecal diversion for sphincter repair. Dis Colon Rectum 2000; 43:961–964.

14. Chassagne P, Jego A, Gloc P, Capet C, Trivalle C, Doucet J, Denis P, Bercoff E. Does treatment of constipation improve faecal incontinence in institutionalized elderly patients? Age Ageing 2000; 29:159–164.

15. Carapeti EA, Kamm MA, Phillips RK. Randomized controlled trial of topical phenylephrine in the treatment of faecal incontinence. Br J Surg 2000; 87:38–42.

16. Cooper P, Gray D. Comparison of two skin care regimes for incontinence. Br J Nurs 2001; 10:S6, S8, S10.

17. Glazener CM, Herbison GP, Wilson PD, MacArthur C, Lang GD, Gee H, Grant AM. Conservative management of persistent postnatal urinary and faecal incontinence: randomised controlled trial. BMJ 2001; 323:593–596.

18. Bliss DZ, Jung HJ, Savik K, Lowry A, LeMoine M, Jensen L, Werner C, Schaffer K. Supplementation with dietary fiber improves fecal incontinence. Nurs Res 2001; 50:203–213.

19. Stamp G, Kruzins G, Crowther C. Perineal massage in labour and prevention of perineal trauma: randomised controlled trial. BMJ 2001; 322:1277–1280.

20. Cheetham MJ, Kamm MA, Phillips RK. Topical phenylephrine increases anal canal resting pressure in patients with faecal incontinence. Gut 2001; 48:356–359.

21. Fitzpatrick M, Harkin R, McQuillan K, O’Brien C, O’Connell PR, O’Herlihy C. A randomised clinical trial comparing the effects of delayed versus immediate pushing with epidural analgesia on mode of delivery and faecal continence. BJOG 2002; 109:1359–1365.

22. Lewis-Byers K, Thayer D. An evaluation of two incontinence skin care protocols in a long-term care setting. Ostomy Wound Manage 2002; 48:44–51.

23. Schnelle JF, Alessi CA, Simmons SF, Al Samarrai NR, Beck JC, Ouslander JG. Translating clinical research into practice: a randomized controlled trial of exercise and incontinence care with nursing home residents. J Am Geriatr Soc 2002; 50:1476–1483.

24. Hannah ME, Hannah WJ, Hodnett ED, Chalmers B, Kung R, Willan A, Amankwah K, Cheng M, Helewa M, Hewson S, Saigal S, Whyte H, Gafni A. Outcomes at 3 months after planned cesarean vs planned vaginal delivery for breech presentation at term: the international randomized Term Breech Trial. JAMA 2002; 287:1822–1831.

25. Zimmerman DD, Gosselink MP, Hop WC, Darby M, Briel JW, Schouten WR. Impact of two different types of anal retractor on fecal continence after fistula repair: a prospective, randomized, clinical trial. Dis Colon Rectum 2003; 46:1674–1679.

26. Norton C, Chelvanayagam S, Wilson-Barnett J, Redfern S, Kamm MA. Randomized controlled trial of biofeedback for fecal incontinence. Gastroenterology 2003; 125:1320–1329.

27. Solomon MJ, Pager CK, Rex J, Roberts R, Manning J. Randomized, controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence. Dis Colon Rectum 2003; 46:703–710.

28. Fitzpatrick M, Behan M, O’Connell PR, O’Herlihy C. Randomised clinical trial to assess anal sphincter function following forceps or vacuum assisted vaginal delivery. BJOG 2003; 110:424–429.

29. Bates-Jensen BM, Alessi CA, Al Samarrai NR, Schnelle JF. The effects of an exercise and incontinence intervention on skin health outcomes in nursing home residents. J Am Geriatr Soc 2003; 51:348–355.

30. Schnelle JF, Kapur K, Alessi C, Osterweil D, Beck JG, Al Samarrai NR, Ouslander JG. Does an exercise and incontinence intervention save healthcare costs in a nursing home population? J Am Geriatr Soc 2003; 51:161–168.

31. Tjandra JJ, Lim JF, Hiscock R, Rajendra P. Injectable silicone biomaterial for fecal incontinence caused by internal anal sphincter dysfunction is effective. Dis Colon Rectum 2004; 47:2138–2146.

32. O’Brien PE, Dixon JB, Skinner S, Laurie C, Khera A, Fonda D. A prospective, randomized, controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphincter) for the control of fecal incontinence. Dis Colon Rectum 2004; 47:1852–1860.

33. Harari D, Norton C, Lockwood L, Swift C. Treatment of constipation and fecal incontinence in stroke patients: randomized controlled trial. Stroke 2004; 35:2549–2555.

34. Mahony RT, Malone PA, Nalty J, Behan M, O’Connell PR, O’Herlihy C. Randomized clinical trial of intra-anal electromyographic biofeedback physiotherapy with intra-anal electromyographic biofeedback augmented with electrical stimulation of the anal sphincter in the early treatment of postpartum fecal incontinence. Am J Obstet Gynecol 2004; 191:885–890.

35. Osterberg A, Edebol Eeg-Olofsson K, Hallden M, Graf W. Randomized clinical trial comparing conservative and surgical treatment of neurogenic faecal incontinence. Br J Surg 2004; 91:1131–1137.

36. Davis KJ, Kumar D, Poloniecki J. Adjuvant biofeedback following anal sphincter repair: a randomized study. Aliment Pharmacol Ther 2004; 20:539–549.

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38. Leroi AM, Parc Y, Lehur PA, Mion F, Barth X, Rullier E, Bresler L, Portier G, Michot F. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg 2005; 242:662–669.

39. Fox M, Stutz B, Menne D, Fried M, Schwizer W, Thumshirn M. The effects of loperamide on continence problems and anorectal function in obese subjects taking orlistat. Dig Dis Sci 2005; 50:1576–1583.

40. Faltin DL, Boulvain M, Floris LA, Irion O. Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial. Obstet Gynecol 2005; 106:6–13.

41. Garcia V, Rogers RG, Kim SS, Hall RJ, Kammerer-Doak DN. Primary repair of obstetric anal sphincter laceration: a randomized trial of two surgical techniques. Am J Obstet Gynecol 2005; 192:1697–1701.

42. Ilnyckyj A, Fachnie E, Tougas G. A randomized-controlled trial comparing an educational intervention alone vs education and biofeedback in the management of faecal incontinence in women. Neurogastroenterol Motil 2005; 17:58–63.

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Parés, D., Norton, C. & Chelvanayagam, S. Fecal Incontinence: The Quality of Reported Randomized, Controlled Trials in the Last Ten Years. Dis Colon Rectum 51, 88–95 (2008). https://doi.org/10.1007/s10350-007-9146-7

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  • DOI: https://doi.org/10.1007/s10350-007-9146-7

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