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. 2011 Sep 7;2011(9):CD001544. doi: 10.1002/14651858.CD001544.pub4

Bretagnol 2010.

Methods Randomisation was performed centrally via an interactive voice randomisation system.
Single‐blinded: the surgeon was blinded to the randomisation process and the preparation status of all patients.
Withdrawal/dropout:7 patients were excluded (5 missing consent form, 1 refusal of surgical treatment, 1 loss of follow‐up).
Follow‐up: 30 days postoperative.
Participants Inclusion criteria: all the patients aged 18 years or old with rectal cancer who underwent laparoscopic or open elective rectal resection with mesorectal excision and sphincter preservation.
Exclusion criteria: very low tumours (abdominal perineal excision): metastasis in the liver or lungs; T4 rectal cancer; synchronous adenocarcinoma; and/or gastrointestinal disease, refusing extensive colonic surgery.
Diseases: rectal cancer.
Number of participants: 178 (102 male; 76 female).
Age: 54 ‐ 71 years.
Location of study: 8 french hospitals (Paris (2 hospitals), Bordeaux, Montpellier, Marseilles, Toulouse, Boulogne Billancourt, Clermont‐Ferrand).
Antibiotics: 500 mg of metronidazole + 1 g of ceftriaxone at anaesthetic induction and were continued every 2 hours during the surgical procedure.
Interventions Group A ‐ MBP (n = 89): oral laxatives and retrograde enemas ‐ senna solution. After the preparation diet was confined to clear fluids.
Group B ‐ no MBP (n = 89): no preoperative dietary restrictions.
Outcomes Anastomotic leakage: Group A = 8, Group B ‐ 17
‐ Asymptomatic anastomotic leakage: Group A = 2, Group B = 3;
‐ Clinical anastomotic leakage: Group A = 6, Group B = 14.
Wound abscess: Group A = 3, Group B = 1.
Pelvic abscess: Group A = 1, Group B = 7.
Peritonitis: Group A = 2, Group B = 6.
Reoperation: Group A = 12, Group B = 5.
Infectious abdominal complications: Group A = 15, Group B = 34.
Infectious extra abdominal complications: Group A = 1, Group B = 1.
Non infectious abdominal complications: Group A = 7, Group B = 14.
Non infectious extra abdominal complications: Group A = 5, Group B = 1.
Necessity to rectal stump washout intra operatively for pool preparation: Group A = 43, Group B = 47.
Intraoperative faecal spillage: Group A = 2, Group B = 7.
Notes A multicenter study: 8 participating national (France) hospitals.
Included patients with preoperative radiotherapy and chemiotherapy.
Intention‐to‐treat analysis was performed.
The sample size was calculated (n = 90 participants, in each group).
Temporaly ileostomy: Group A = 71, Group B = 74.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate