Background Decreased surgical site infections (SSIs) and morbidity have been reported with mechanical and oral antibiotic bowel preparation (MOABP) compared with no bowel preparation (NBP) in colonic surgery. Several societies have recommended routine use of MOABP in patients undergoing colon resection on the basis of these data. Our aim was to investigate this recommendation in a prospective randomised context. Methods In this multicentre, parallel, single-blinded trial, patients undergoing colon resection were randomly assigned (1:1) to either MOABP or NBP in four hospitals in Finland, using a web-based randomisation technique. Randomly varying block sizes (four, six, and eight) were used for randomisation, and stratification was done according to centre. The recruiters, treating physicians, operating surgeons, data collectors, and analysts were masked to the allocated treatment. Key exclusion criteria were need for emergency surgery; bowel obstruction; colonoscopy planned during surgery; allergy to polyethylene glycol, neomycin, or metronidazole; and age younger than 18 years or older than 95 years. Study nurses opened numbered opaque envelopes containing the patient allocated group, and instructed the patients according to the allocation group to either prepare the bowel, or not prepare the bowel. Patients allocated to MOABP prepared their bowel by drinking 2 L of polyethylene glycol and 1 L of clear fluid before 6 pm on the day before surgery and took 2 g of neomycin orally at 7 pm and 2 g of metronidazole orally at 11 pm the day before surgery. The primary outcome was SSI within 30 days after surgery, analysed in the modified intention-to-treat population (all patients who were randomly allocated to and underwent elective colon resection with an anastomosis) along with safety analyses. The trial is registered with ClinicalTrials.gov, NCT02652637, and EudraCT, 2015-004559-38, and is closed to new participants.
Aim
The extralevator abdominoperineal excision (ELAPE) has been expected to reduce the risk of positive circumferential resection margins (CRMs) and local recurrence in locally advanced distal rectal cancer. The aim was to determine whether there is any difference in local recurrence rates between patients who were operated on for distal rectal cancer before and after the introduction of ELAPE in our unit.
Patients and methods
In all, 206 patients with distal rectal cancer without distant metastases (T1‐4N0‐2M0) were treated with curative intent. The patients were divided into two cohorts operated in 2000–2007 (A) and 2008–2014 (B). The ELAPE procedure was introduced in 2008. Since then, it has been used in cases of T4 and T3 tumours with threatened margins. In T1–T3 tumours without threatened margins a conventional abdominal perineal excision has been performed.
Results
There was no significant difference in overall survival or cancer‐specific survival between the two time periods. The local recurrence rate was 15.5% in group A and 6.7% in group B (P = 0.048), although there was no significant difference in the cumulative local recurrence rate. Intra‐operative tumour perforation occurred significantly more often during the earlier period when ELAPE was not in use: group A 15/71 (21.1%) vs group B 11/135 (8.1%), P = 0.01. CRM was positive more often in group A (16.4%) vs group B (7.4%), P = 0.054.
Conclusion
The local recurrence rate, intra‐operative tumour perforation and positive CRM rate were significantly lower during the later period when more extensive surgery (ELAPE) was performed for locally advanced T3–T4 rectal cancer with threatened margins.
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