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Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection—Reply | JAMA Surgery | ÌÇÐÄvlog

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Comment & Response
September 4, 2024

Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection—Reply

Author Affiliations
  • 1Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
JAMA Surg. 2024;159(11):1327-1328. doi:10.1001/jamasurg.2024.2992

In Reply We thank the members of the Clinical Research Appraisal and Methodology for Surgical Trainees (CRAMSURG) journal club for their valuable remarks concerning the MOBILE2 randomized clinical trial.1 The Comprehensive Complication Index (CCI) was chosen to show the potential overall benefit (or harm) of oral antibiotics. We hypothesized that oral antibiotics may have a benefit in terms of surgical site infections (SSIs) but might also have some unexpected adverse effects. The CCI takes all complications into account. From patients’ perspective, overall complication burden matters most, not just SSIs. For reporting clinical trial results, it is irrelevant whether the metric is used in clinical practice or not. The CCI has been specifically designed for use as an outcome in surgical randomized clinical trials rather than clinical use. The maximum score a metric can obtain does not affect clinically significant difference. A Clavien-Dindo Classification score of 1 is equivalent to 8.7 points in the CCI, and thus the trial was designed with sufficient power to detect such a difference. SSIs are reported as a secondary outcome and can be found in the publication.1 Antibiotics were chosen so that they would have a broad spectrum of action on bowel mucosa. Neomycin has poor absorbability, which is a positive effect in this case. The most common antibiotic combination has historically been neomycin plus erythromycin, but metronidazole was chosen for its action toward anaerobic bacteria. Partial total mesorectal excision here means partial mesorectal excision, for which the correct abbreviation is PME. We apologize for the inaccuracy in the abbreviation. Neoadjuvant treatment strategy followed Finnish colorectal cancer treatment guidelines, in which a T3 tumor with no mesorectal fascia involvement (MRF-) is not an independent indication for neoadjuvant treatment. The indications for short-course radiotherapy are, in brief, N2 disease and extramural venous invasion in T3 MRF- disease. For long-course chemoradiotherapy, the indications are MRF+ in T3 disease, T4 disease, or extrafascial lymph nodes. Total neoadjuvant therapy is still selectively used in Finland, primarily for locally advanced T4 tumors with extramural vascular invasion, N2, and/or extrafascial lymph nodes. We do not agree that a patient’s participation in a study could have promoted risk-aversion behavior in surgeons, and we have not noted any such behavior. Randomized clinical trials are routine in our unit, and patients participating in trials are treated the same way as patients not participating in trials, unless the trial protocol dictates otherwise. As seen in the Figure 1 flowchart in the original publication,1 only a few patients were excluded from the trial. Further, as the study was double-blinded, the surgeons did not know which group the patient belonged to, and thus surgeons could not have altered their behavior based on the allocation group. For ethical reasons, it was necessary to give the option for protective stoma at the discretion of the operating surgeon.

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