Skip to main content
SpringerLink
Log in

Preoperative mechanical bowel preparation using conventional versus hyperosmolar polyethylene glycol-electrolyte lavage solution before laparoscopic resection for colorectal cancer (TLUMP test): a phase III, multicenter randomized controlled non-inferiority trial

  • Original Article—Alimentary Tract
  • Published:
Journal of Gastroenterology Aims and scope Submit manuscript

Abstract

Background

A hyperosmolar ascorbic acid-enriched polyethylene glycol-electrolyte (ASC-PEG) lavage solution ensures excellent bowel preparation before colonoscopy; however, no study has demonstrated the efficacy of this lavage solution before surgery. This study aimed to establish the non-inferiority of ASC-PEG to the standard polyethylene glycol-electrolyte solution (PEG-ELS) in patients undergoing laparoscopic resection for colorectal cancer.

Methods

This was a prospective, single-blind, multicenter, randomized, controlled, non-inferiority clinical trial. Overall, 188 patients scheduled for laparoscopic colorectal resection for single colorectal adenocarcinomas were randomly assigned to undergo preparation with different PEG solutions between August 2017 and April 2020 at four hospitals in Japan. Participants received ASC-PEG (Group A) or PEG-ELS (Group B) preoperatively. The primary endpoint was the ratio of successful bowel preparations using the modified Aronchick scale, defined as “excellent” or “good.”

Results

After exclusion, 86 and 87 patients in Groups A and B, respectively, completed the study, and their data were analyzed. ASC-PEG was not inferior to PEG-ELS in terms of effective bowel preparation prior to laparoscopic colorectal resection (0.93 vs. 0.92; 95% confidence interval, − 0.078 to 0.099, p = 0.007). The total volume of cleansing solution intake was lower in Group A than in Group B (1757.0 vs. 1970.1 mL). Two and three severe postoperative adverse events occurred in Groups A and B, respectively. Patient tolerance of the two solutions was almost equal.

Conclusions

ASC-PEG is effective for preoperative bowel preparation in patients undergoing laparoscopic resection for colorectal cancer and is non-inferior to PEG-ELS.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Pak H, Maghsoudi LH, Soltanian A, et al. Surgical complications in colorectal cancer patients. Ann Med Surg (Lond). 2020;55:13–8.

    Article  PubMed  Google Scholar 

  2. Jung B, Påhlman L, Nyström PO, et al. Multicentre randomized clinical trial of mechanical bowel preparation in elective colonic resection. Br J Surg. 2007;94:689–95.

    Article  CAS  PubMed  Google Scholar 

  3. Contant CM, Hop WC, van’t Sant HP, et al. Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial. Lancet. 2007;370:2112–7.

    Article  PubMed  Google Scholar 

  4. Markell KW, Hunt BM, Charron PD, et al. Prophylaxis and management of wound infections after elective colorectal surgery: a survey of the American Society of Colon and Rectal Surgeons membership. J Gastrointest Surg. 2010;14:1090–8.

    Article  PubMed  Google Scholar 

  5. Kang BM, Lee KY, Park SJ, et al. Mechanical bowel preparation and prophylactic antibiotic administration in colorectal surgery: a survey of the current status in Korea. Ann Coloproctol. 2013;29:160–6.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Roig JV, García-Fadrique A, García-Armengol J, et al. Mechanical bowel preparation and antibiotic prophylaxis in colorectal surgery: use by and opinions of Spanish surgeons. Colorectal Dis. 2009;11:44–8.

    Article  CAS  PubMed  Google Scholar 

  7. Zerey M, Hawver LM, Awad Z, et al. SAGES evidence-based guidelines for the laparoscopic resection of curable colon and rectal cancer. Surg Endosc. 2013;27:1–10.

    Article  PubMed  Google Scholar 

  8. Davis GR, Santa Ana CA, Morawski SG, et al. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980;78:991–5.

    Article  CAS  PubMed  Google Scholar 

  9. Johnson DA, Barkun AN, Cohen LB, et al. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014;147:903–24.

    Article  PubMed  Google Scholar 

  10. Oliveira L, Wexner SD, Daniel N, et al. Mechanical bowel preparation for elective colorectal surgery. A prospective, randomized, surgeon-blinded trial comparing sodium phosphate and polyethylene glycol-based oral lavage solutions. Dis Colon Rectum. 1997;40:585–91.

    Article  CAS  PubMed  Google Scholar 

  11. Bingöl-Koloğlu M, Şenocak ME, Talim B, et al. A comparative histopathologic evaluation of the effects of three different solutions used for whole bowel irrigation: an experimental study. J Pediatr Surg. 2000;35:564–8.

    Article  PubMed  Google Scholar 

  12. Ueno F, Kudo S, Igarashi M, et al. Efficacy and safety of a reduced-volume polyethylene-glycol electrolyte lavage solution plus ascorbic acid in preparation for colonoscopy: a randomized trial. J New Remedies Clin. 2016;65:681–95.

    Google Scholar 

  13. Xie Q, Chen L, Zhao F, et al. A meta-analysis of randomized controlled trials of low-volume polyethylene glycol plus ascorbic acid versus standard-volume polyethylene glycol solution as bowel preparations for colonoscopy. PLoS ONE. 2014;9: e99092.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Tajika M, Tanaka T, Ishihara M, et al. A randomized controlled trial evaluating a low-volume PEG solution plus ascorbic acid versus standard PEG solution in bowel preparation for colonoscopy. Gastroenterol Res Pract. 2015;2015: 326581.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Pontone S, Angelini R, Standoli M, et al. Low-volume plus ascorbic acid vs high-volume plus simethicone bowel preparation before colonoscopy. World J Gastroenterol. 2011;17:4689–95.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Watanabe T, Itabashi M, Shimada Y, et al. Japanese society for cancer of the colon and rectum (JSCCR) guidelines 2014 for treatment of colorectal cancer. Int J Clin Oncol. 2015;20:207–39.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Ichikawa N, Homma S, Funakoshi T, et al. Impact of technically qualified surgeons on laparoscopic colorectal resection outcomes: results of a propensity score-matching analysis. BJS Open. 2020;4:486–98.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. Akagi T, Endo H, Inomata M, et al. Clinical impact of endoscopic surgical skill qualification system (ESSQS) by Japan society for endoscopic surgery (JSES) for laparoscopic distal gastrectomy and low anterior resection based on the National clinical database (NCD) registry. Ann Gastroenterol Surg. 2020;4:721–34.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Kastenberg D, Bertiger G, Brogadir S. Bowel preparation quality scales for colonoscopy. World J Gastroenterol. 2018;24:2833–43.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Aronchick CA, Lipshutz WH, Wright SH, et al. Validation of an instrument to assess colon cleansing. Am J Gastroenterol. 1999;94:2667.

    Google Scholar 

  21. Yamaguchi T, Inatsugi N, Yoshikawa S, et al. Optimum mechanical bowel preparation for laparoscopic surgery: a prospective, randomized trial comparing magnesium citrate (MGC) and polyethylene glycol electrolyte solution (PEG). Nippon Daicho Komonbyo Gakkai Zasshi. 2011;64:62–6.

    Article  Google Scholar 

  22. Tsuchiya S, Mitomi T, Hiki Y, et al. Phase II study of oral gastrointestinal lavage solution in preparation for colonic surgery. Yakuri to Chiryo. 1989;17:267–82.

    Google Scholar 

  23. Matsuda S, Akaike N. Bowel cleansing effect of AJF522 in rats. J New Rem Clin. 2012;61:51–7.

    Google Scholar 

  24. Zmora O, Lebedyev A, Hoffman A, et al. Laparoscopic colectomy without mechanical bowel preparation. Int J Colorectal Dis. 2006;21:683–7.

    Article  PubMed  Google Scholar 

  25. Mai-Phan AT, Nguyen H, Nguyen TT, et al. Randomized controlled trial of mechanical bowel preparation for laparoscopy-assisted colectomy. Asian J Endosc Surg. 2019;12:408–11.

    Article  PubMed  Google Scholar 

  26. Allaix ME, Arolfo S, Degiuli M, et al. Laparoscopic colon resection: to prep or not to prep? Analysis of 1535 patients. Surg Endosc. 2016;30:2523–9.

    Article  PubMed  Google Scholar 

  27. Fujita I, Akagi Y, Hirano J, et al. Distinct mechanisms of transport of ascorbic acid and dehydroascorbic acid in intestinal epithelial cells (IEC-6). Res Commun Mol Pathol Pharmacol. 2000;107:219–31.

    CAS  PubMed  Google Scholar 

  28. Hornig D, Vuilleumier JP, Hartmann D. Absorption of large, single, oral intakes of ascorbic acid. Int J Vitam Nutr Res. 1980;50:309–14.

    CAS  PubMed  Google Scholar 

  29. Kim B, Lee SD, Han KS, et al. Comparative evaluation of the efficacy of polyethylene glycol with ascorbic acid and an oral sulfate solution in a split method for bowel preparation: a randomized, multicenter phase III clinical trial. Dis Colon Rectum. 2017;60:426–32.

    Article  PubMed  Google Scholar 

  30. Tamaki H, Noda T, Morita M, et al. Efficacy of 1.2 L polyethylene glycol plus ascorbic acid for bowel preparations. World J Clin Cases. 2019;7:452–65.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Bucher P, Gervaz P, Soravia C, et al. Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery. Br J Surg. 2005;92:409–14.

    Article  CAS  PubMed  Google Scholar 

  32. Ell C, Fischbach W, Keller R, et al. A randomized, blinded, prospective trial to compare the safety and efficacy of three bowel-cleansing solutions for colonoscopy (HSG-01*). Endoscopy. 2003;35:300–4.

    Article  CAS  PubMed  Google Scholar 

  33. Belsey J, Epstein O, Heresbach D. Systematic review: adverse event reports for oral sodium phosphate and polyethylene glycol. Aliment Pharmacol Ther. 2009;29:15–28.

    Article  CAS  PubMed  Google Scholar 

  34. Radaelli F, Meucci G, Imperiali G, et al. High-dose senna compared with conventional PEG-ES lavage as bowel preparation for elective colonoscopy: a prospective, randomized, investigator-blinded trial. Am J Gastroenterol. 2005;100:2674–80.

    Article  PubMed  Google Scholar 

  35. Kim TK, Kim HW, Kim SJ, et al. Importance of the time interval between bowel preparation and colonoscopy in determining the quality of bowel preparation for full-dose polyethylene glycol preparation. Gut Liver. 2014;8:625–31.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

The authors thank Dr. K. Noguchi, Dr. Y. Tanaka, Dr. H. Nakamoto, Dr. T. Sakata, Dr. Y. Wakui, Dr. H. Kasai, Dr. T. Kobayashi, Dr. R. Murata, and Dr. Y. Terasaki for assisting with the study. EA Pharma Co., Ltd contributed to the study funding but had no input towards the study design, data collection, interpretation of results, or decision to publish.

Author information

Authors and Affiliations

  1. Department of Gastroenterological Surgery I, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan

    Tadashi Yoshida, Shigenori Homma, Nobuki Ichikawa, Yosuke Ohno, Yoichi Miyaoka, Hiroki Matsui, Ken Imaizumi & Akinobu Taketomi

  2. Department of Surgery, Sapporo-Kosei General Hospital, N3, E8, Chuo-ku, Sapporo, Hokkaido, Japan

    Yosuke Ohno, Hiroyuki Ishizu & Tohru Funakoshi

  3. Department of Surgery, KKR Sapporo Medical Center, Hiragishi 1-jo, 6-chome, Toyohira-ku, Sapporo, Hokkaido, Japan

    Masahiko Koike & Hirofumi Kon

  4. Department of Surgery, Iwamizawa Municipal General Hospital, 9-jo, W7, Iwamizawa, Hokkaido, Japan

    Yo Kamiizumi & Yasuhiro Tani

  5. Biostatistics Division, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, Hokkaido, Japan

    Yoichi Minagawa Ito & Kazufumi Okada

Authors
  1. Tadashi Yoshida
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Shigenori Homma
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Nobuki Ichikawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yosuke Ohno
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Yoichi Miyaoka
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Hiroki Matsui
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Ken Imaizumi
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Hiroyuki Ishizu
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Tohru Funakoshi
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Masahiko Koike
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Hirofumi Kon
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Yo Kamiizumi
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Yasuhiro Tani
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Yoichi Minagawa Ito
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Kazufumi Okada
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Akinobu Taketomi
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

All authors have contributed either to the conception, data acquiring and analysis, drafting, or critical revision of this manuscript, and have given their approval of its contents.

Corresponding author

Correspondence to Shigenori Homma.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Yoshida, T., Homma, S., Ichikawa, N. et al. Preoperative mechanical bowel preparation using conventional versus hyperosmolar polyethylene glycol-electrolyte lavage solution before laparoscopic resection for colorectal cancer (TLUMP test): a phase III, multicenter randomized controlled non-inferiority trial. J Gastroenterol 58, 883–893 (2023). https://doi.org/10.1007/s00535-023-02019-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00535-023-02019-1

Keywords

Search

Navigation