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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

Roth 2013.

Methods Randomised clinical trial, Switzerland
Participants 157 hospitalised adults undergoing surgery with pelvic lymph node dissection, cystectomy and ileal diversion for bladder cancer, at nutritional risk due to major surgery
Male:Female = 106:51
Mean age = 67 years
Exclusion criteria: previous pelvic lymph node dissection, previous radiation therapy, prior bowel surgery, severe hepatic or cardiac dysfunction, an inability to give fully informed consent
Interventions Experimental group: TPN consisting of Nutriflex special 70/240 (B. Braun Medical, Melsungen, Germany), a solution with a total energy of 1240 kcal/1000 ml and containing polyamino acids, glucose, and electrolytes. TPN (1500 ml/day; total 1860 kcal/day; 105 g polyamino acids/day; 360 g glucose/day; 0 g lipids/day) was administered continuously for 5 days starting on postoperative day 1. No intravenous supplementation of vitamins or trace elements were given. An additional 30 IU Actrapid HM (Novo Nordisk, Copenhagen, Denmark) and 1875 IU heparin (Liquemin; Drossapharm, Basel‐Stadt, Switzerland) every 24 hrs were added to the TPN solution. (n = 74)
Control group: Ringer’s lactate solution
 (Sintetica–Bioren, Mendrisio, Switzerland; 1500 ml/24 h) and additional potassium substitution (40 mmol/24 h) (n = 83)
Co‐interventions: Oral intake was started with clear fluids on the day of surgery, with fluids started on postoperative day 1. Solid diet was resumed on the return of active bowel sounds and when fluids were well tolerated. Perioperatively, a central venous catheter was placed in all participants. Perioperative antibiotic therapy consisted of aminoglycoside and metronidazole for 48 hrs and amoxicilin/clavulanic acid until removal of all stents and catheters. Perioperatively, 3000 ‐ 4000 ml of parenteral crystalloids were routinely administered. Combined general and epidural anaesthesia were given intra‐operatively. Postoperative epidural (T9 ‐ T10) analgesia was routinely used, but systemic morphine derivates were avoided. To stimulate postoperative bowel function, subcutaneous injections of 0.5 mg neostigmine methylsulfate up to 6 times a day were administered to all in similar distribution starting on postoperative day 2 and continuing until bowel activity resumed. Anti‐emetics and other prokinetic drugs were not routinely administered and only given as needed. Low‐molecular‐weight heparin (Fraxiparine) was started on the evening before surgery and maintained for at least 10 days.
Outcomes Occurence of postoperative complications, time to recovery of bowel function, biochemical nutritional (serum albumin, serum prealbumin, serum total protein) and inflammatory (C‐reactive protein) parametres, length of hospital stay, cost attributed to the TPN, time to full diet resumption
Study dates September 2008 and March 2011
Notes We contacted the authors on 07th April 2016 by email: urology.berne@insel.ch.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done by a computer‐based programme.
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding was not performed.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No drop‐outs, none lost to follow‐up
Selective reporting (reporting bias) Low risk No protocol could be obtained but the trial reported complications and mortality.
For‐profit bias Low risk The trial was not funded by any company that might have a vested interest in the results.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.