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Single-blinded Randomized Trial of Mechanical Bowel Preparation for Colon Surgery with Primary Intraperitoneal Anastomosis

  • 2008 ssat plenary presentation
  • Published:
Journal of Gastrointestinal Surgery

Abstract

Introduction

We report the final analysis of a prospective single-blinded randomized trial designed to investigate whether omission of preoperative mechanical bowel preparation increases the rate of surgical-site infection and anastomotic failure after elective colon surgery with intraperitoneal anastomosis by a single surgeon.

Patients and Methods

Patients scheduled to undergo an elective colon or proximal rectal resection with a primary anastomosis by a single surgeon were randomized to receive either oral polyethylene glycol (Group A) or no mechanical bowel preparation (Group B). Patients were followed by an independent surgeon.

Results

One hundred and forty nine patients were enrolled. Three patients (2%) were preoperatively excluded because of active immunosuppression and 13 (9%) were excluded from the final analysis. Of the remaining 129 patients, 65 were assigned to Group A and 64 to Group B. Thirty patients (23.2%) developed wound infection, (Group A = 24.6% and Group B = 17.2%; NS). There were three cases of intra-abdominal sepsis a (Group A 4.6%). The anastomotic failure rate was 5.4% (n = 7), four patients in Group A (6.2%) vs. three patients in Group B (4.7%) (NS). When SSI and anastomotic failure were combined, the complication rate in Group A was 35.4% vs. 21.9% for Group B. The NNH was 7.4.

Conclusion

Our final analysis shows that a single surgeon will not have a higher rate of either surgical-site infection or anastomotic failure if he/she routinely omits preoperative mechanical bowel preparation.

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Authors and Affiliations

  1. Servicio de Cirugía I, Hospital Clínico San Carlos, Universidad Complutense de Madrid Medical School, Madrid, Spain

    María Jesús Pena-Soria, Julio M. Mayol, Rocio Anula, Ana Arbeo-Escolar & Jesús A. Fernandez-Represa

  2. Surgical Oncology and Colorectal Surgery Units, Servicio de Cirugía I, Hospital Clínico San Carlos, 28040, Madrid, Spain

    Julio M. Mayol

Authors
  1. María Jesús Pena-Soria
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  2. Julio M. Mayol
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  3. Rocio Anula
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  4. Ana Arbeo-Escolar
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  5. Jesús A. Fernandez-Represa
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Corresponding author

Correspondence to Julio M. Mayol.

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Discussion

Final Analysis of a Single-Blinded Randomized Trial of Mechanical Bowel Preparation for Elective Colon Surgery with Primary Intraperitoneal Anastomosis by a Single Surgeon

Madhu Prasad, M.D. (Detroit, MI): I would like to congratulate you on a very fine presentation and also thank you for kindly providing me an early iteration of your manuscript prior to the meeting.

A study like yours a generation ago would have been considered heretical, but there are more and more reports in the literature similar to yours. Despite that, I think in the United States, as you pointed out in your presentation, the notion of elective operation on the colon absent mechanical bowel preparation is something with which many are uncomfortable. As you know, I do not do many colonic procedures, though it is very clear that most of my patients do not listen to my instructions and they come unprepped to surgery anyway. But let me ask you a couple of questions.

Firstly, most of the studies like this that I have seen in the literature tend to be multi-center and multi-surgeon trials. So tell me a little bit about why a single-blinded and single-surgeon study design such as you employed enabled you to make more discrete conclusions? Secondly, have you tried this in the laparoscopic setting, and if not, do you think that there is any application of this in the laparoscopic setting? Thirdly, why did you choose to restrict your analysis to intraperitoneal anastomoses and exclude rectal tumors altogether?

I noticed in your last couple of slides that the rate of surgical-site infection you report in patients who underwent mechanical bowel preparation was 24.6%, which is roughly two- or three-fold higher than reported in most papers in the literature for clean-contaminated surgery. Could you speculate as to the reasons for this, and do you think that this number might have skewed your conclusions in favor of foregoing mechanical bowel preparation?

And finally, do you find that patients that do not undergo mechanical bowel prep require less fluid in the perioperative period and does that enable you to fast track these patients?

Julio M. Mayol, M.D. (Madrid, Spain): Thank you very much, Dr. Prasad. First of all, we designed a single-blinded trial because we wanted to control the experimental conditions of our study as much as possible. When surgeons evaluate their own results, they are usually biased, and we wanted to avoid that. At the same time, we were trying to control for technical variability. Multi-center and multi-surgeon trials are criticized because they disregard technical variability. So by conducting a single-blinded trial with a single surgeon, we obtained a tighter control over our experimental conditions.

Secondly, yes, we have done some cases without mechanical bowel preparation laparoscopically, but with this trial, we cannot answer your question. We would need specific randomized trials to study the impact of mechanical bowel preparation on laparoscopic cases.

With regard to the reason why we just restricted the study to intraperitoneal anastomoses, again, the answer is that we wanted to control the confounding variables. If we had included pelvic anastomoses, most of those cases would have undergone preoperative chemoradiotherapy and had a diverting stoma. Therefore, several additional confounding variables would have been included, making it difficult to interpret their effects on the results and neglecting the advantage of a strict design. That is why we restricted the patients to those who had an intraperitoneal anastomosis.

Four is our infection rate. It is rather high, and we were surprised. But in our study, the surgeon who operated on the patient was not the one reporting the complications. They were assessed by an independent observer; and we were puzzled by the high infection rate, of course. So we went back to the literature. And in 2004, Smith published a retrospective study in the Annals of Surgery showing that when patients are specifically followed up, the infection rate for colon surgery carried out by single surgeon using mechanical bowel preparation was 26% in the United States. So probably in most single trials, where observers are not blinded, there are biases in reporting complications.

And finally, the fast track. Our anesthesiologists complained when patients had had mechanical bowel preparation in the past about the amount of fluid that they need intraoperatively. Older and sick patients suffer from electrolyte imbalance and get dehydrated. They usually need very strong supportive therapy both intraoperatively and postoperatively, and that probably impairs the recovery of those patients. It would be counterintuitive to fast track patients who have mechanical bowel preparation.

Richard A. Hodin, M.D. (Boston, MA):

A quick question on the resolution of ileus. I do not know how carefully you looked at this, but I wonder whether there was any difference in the two groups in terms of passage of gas, bowel movements, and so forth?

Dr. Mayol: We did not look specifically at that, but there are data in the literature from multi-center trials showing that by avoiding mechanical bowel preparation, a shorter postoperative ileus duration is achieved, although it is just 1 day. Patients without mechanical bowel preparation pass gas 1 day before than those who had it. And oral intake is resumed 1 day before. But, again, we did not look at that specifically.

This work was presented in abstract form at the 50th Meeting of the Society of Surgery of The Alimentary Tract.

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Pena-Soria, M.J., Mayol, J.M., Anula, R. et al. Single-blinded Randomized Trial of Mechanical Bowel Preparation for Colon Surgery with Primary Intraperitoneal Anastomosis. J Gastrointest Surg 12, 2103–2109 (2008). https://doi.org/10.1007/s11605-008-0706-5

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