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A Double-Blinded Randomized Clinical Study on the Therapeutic Effect of Gastrografin® in Prolonged Postoperative Ileus After Elective Colorectal Surgery

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Abstract

Background

Postoperative ileus is a common problem with significant clinical and economic consequences. We hypothesized that Gastrografin® may have therapeutic utility by accelerating the recovery of postoperative ileus after colorectal surgery. The aim of this trial was to study the impact of oral Gastrografin® administration on postoperative prolonged ileus (PPI) after elective colorectal surgery.

Methods

The main endpoint of this randomized, double-blinded, controlled trial was time of resolution of PPI. The secondary endpoints were overall hospital length of stay, time to start oral intake, time to first passage of flatus or stools, time of need of nasogastric tube, and need of parenteral nutrition. Included criteria were patients older than 18 years, operated for colonic neoplasia, inflammatory bowel disease, or diverticular disease. There were two treatments: Gastrografin® administration and placebo. The sample size was calculated taking into account the average length of postoperative ileus after colorectal resection until tolerance to oral intake. Statistical analysis showed that 29 subjects in each group were needed.

Results

Twenty-nine patients per group were randomized. Groups were comparable for age, gender, ASA Physical Status Classification System, stoma construction, and surgical technique. No statistical differences were observed in mean time to resolution between the two groups, 9.1 days (CI 95 %, 6.51–11.68) in Gastrografin® group versus 10.3 days (CI 6.96–10.29) in Placebo group (P = 0.878). Even if not statistically significant, time of resolution of PPI, overall length of stay, time of need of nasogastric tube, and time to tolerance of oral intake were shorter in the G group.

Conclusions

Gastrografin® does not accelerate significantly the recovery of prolonged postoperative ileus after elective colorectal resection when compared with placebo. However, it seems to clinically improve all the analyzed variables.

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References

  1. Van Bree SHW, Cailotto C, Di Giovangiulio M et al (2013) Systemic inflammation with enhanced brain activation contributes to more severe delay in postoperative ileus. Neurogastroenterol Motil 25:e540–e549

    Article  PubMed  Google Scholar 

  2. Mattei P, Rombeau JL (2006) Review of the pathophysiology and management of postoperative ileus. World J Surg 30:1382–1391. doi:10.1007/s00268-005-0613-9

    Article  PubMed  Google Scholar 

  3. Iyer S, Saunders WB, Stemkowski S (2009) Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm 15:485–494

    PubMed  Google Scholar 

  4. Vather R, Trivedi S, Bissett I (2013) Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg 17:962–972

    Article  PubMed  Google Scholar 

  5. Bauer J, Boeckstaens GE (2004) Mechanisms of postoperative ileus. Neurogastroenterol Motil 16(Suppl. 2):54–60

    Article  PubMed  Google Scholar 

  6. Vather R, Bissett I (2013) Management of prolonged post-operative ileus: evidence-based recommendations. ANZ J Surg 83:319–324

    Article  PubMed  Google Scholar 

  7. Biondo S, Parés D, Mora L et al (2003) Randomized clinical study of Gastrografin administration in patients with adhesive small bowel obstruction. Br J Surg 90:542–546

    Article  PubMed  CAS  Google Scholar 

  8. Branco BC, Barmparas G, Schnüriger B et al (2010) Systematic review and meta-analysis of the diagnostic and therapeutic role of water soluble contrast agent in adhesive small bowel obstruction. Br J Surg 97:470–478

    Article  PubMed  CAS  Google Scholar 

  9. Artinyan A, Nunoo-Mensah JW, Balasubramaniam S et al (2008) Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg 32:1495–1500. doi:10.1007/s00268-008-9491-2

    Article  PubMed  Google Scholar 

  10. Chapuis PH, Bokey L, Keshava A et al (2013) Risk factors for prolonged ileus after resection of colorectal cancer. An observational study of 2400 consecutive patients. Ann Surg 257:909–915

    Article  PubMed  Google Scholar 

  11. Manara L, Bianchetti A (1985) The central and peripheral influences of opioids on gastrointestinal propulsion. Annu Rev Pharmacol Toxicol 25:249–273

    Article  PubMed  CAS  Google Scholar 

  12. Frantzides CT, Condon RE, Schulte WJ et al (1990) Effects of morphine on colonic myoelectric and motor activity in subhuman primates. Am J Physiol 258:247–252

    Google Scholar 

  13. Lubawski L, Saclarides T (2008) Postoperative ileus: strategies for reduction. Ther Clin Risk Manag 4:913–917

    PubMed  CAS  PubMed Central  Google Scholar 

  14. Carli F, Trudel JL, Belliveau P (2001) The effect of intraoperative thoracic epidural anesthesia and postoperative analgesia on bowel function after colorectal surgery: a prospective, randomized trial. Dis Colon Rectum 44:1083–1089

    Article  PubMed  CAS  Google Scholar 

  15. Zugel N, Bruer C, Breitschaft K et al (2000) Effect of thoracic epidural analgesia on the early postoperative phase after interventions on the gastrointestinal tract. Chirurg 73:262–268

    Article  Google Scholar 

  16. Spanjersberg WR, Reurings J, Keus F et al (2011) Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev (2):CD007635

  17. Chambers D, Paton F, Wilson P et al (2014) An overview and methodological assessment of systematic reviews and meta-analyses of enhanced recovery programmes in colorectal surgery. BMJ Open 4:e005014

    Article  PubMed  PubMed Central  Google Scholar 

  18. Seta ML, Kale-Pradhan PB (2001) Efficacy of metoclopramide in postoperative ileus after exploratory laparotomy. Pharmacotherapy 21:1181–1186

    Article  PubMed  CAS  Google Scholar 

  19. Smith AJ, Nissan A, Lanouette NM et al (2000) Prokinetic effect of erythromycin after colorectal surgery: randomized, placebo-controlled, double blind study. Dis Colon Rectum 43:333–337

    Article  PubMed  CAS  Google Scholar 

  20. Choi HK, Chu KW, Law WL (2002) Therapeutic value of Gastrografin in adhesive small bowel obstruction after unsuccessful conservative treatment: a prospective randomized trial. Ann Surg 236:1–6

    Article  PubMed  PubMed Central  Google Scholar 

  21. Watkins DT, Robertson CL (1985) Water-soluble radiocontrast material in the treatment of postoperative ileus. Am J Obstet Gynecol 152:450–455

    Article  PubMed  CAS  Google Scholar 

  22. Finan MA, Barton DP, Fiorica JV et al (1995) Ileus following gynecologic surgery: management with water-soluble hyperosmolar radiocontrast material. South Med J 88:539–542

    Article  PubMed  CAS  Google Scholar 

  23. Vather R, Josephson R, Jaung R et al (2015) Gastrografin in prolonged postoperative ileus- a double-blinded randomized controlled trial. Ann Surg 262:23–30

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

The authors thank Mr Bernat Miguel, Data Manager of the Colorectal Unit, University Hospital of Bellvitge and IDIBELL, for the statistical analysis.

Grant support

This study has been supported by a grant by the Ministry of Health and Social Policy, Government of Spain. EC10-160. Noncommercial interests.

Author information

Author notes

    Authors and Affiliations

    1. Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/Feixa Llarga s/n, L’Hospitalet de Llobregat, 08907, Barcelona, Spain

      Sebastiano Biondo, Jordi Miquel, Thomas Golda, Ricardo Frago & Esther Kreisler

    2. Colorectal Unit, Department of General and Digestive Surgery, Vall d’Hebron University Hospital, Barcelona, Spain

      Eloy Espin-Basany & Jose Luis Sanchez

    3. Department of Pharmacy, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain

      Ana Maria Ferrer-Artola

    4. Colorectal Unit, Department of General and Digestive Surgery, Josep Trueta University Hospital, Girona, Spain

      Antonio Codina-Cazador

    Authors
    1. Sebastiano Biondo
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    2. Jordi Miquel
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    3. Eloy Espin-Basany
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    4. Jose Luis Sanchez
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    5. Thomas Golda
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    6. Ana Maria Ferrer-Artola
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    7. Antonio Codina-Cazador
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    8. Ricardo Frago
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    9. Esther Kreisler
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    Corresponding author

    Correspondence to Sebastiano Biondo.

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    There are no conflicts of interest.

    Additional information

    Accepted as oral paper at the 22 European Surgical Association (ESA) meeting, Warsaw 2015.

    EudraCT: 2010-024096-87; ClinicalTrials.gov: NCT01440712.

    Sebastiano Biondo and Jordi Miquel have contributed equally to this paper.

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    Biondo, S., Miquel, J., Espin-Basany, E. et al. A Double-Blinded Randomized Clinical Study on the Therapeutic Effect of Gastrografin® in Prolonged Postoperative Ileus After Elective Colorectal Surgery. World J Surg 40, 206–214 (2016). https://doi.org/10.1007/s00268-015-3260-9

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    • DOI: https://doi.org/10.1007/s00268-015-3260-9

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