Lee 2013.

Study characteristics
Methods	Randomised controlled trial. Parallel group.
Participants	Inclusion Criteria; Adults 18 yrs and over admitted to the Auckland Medical Hospital, diagnosed with malignant bowel obstruction as defined by the International Conference on MBO, with no indication for other treatments e.g. surgery, endoscopy, etc. Exclusion Criteria; Pregnancy. Inability to give informed consent. Allergy to gastrografin or iodine. Evidence of gross gastric distension on radiologic examination. Prescence of a venting or feeding gastrostomy or jejunostomy. Due to the limited number of participants (2), who completed assessment in the intervention arm a comparison of group differences cannot be made.
Interventions	The trial ran from February 2011 to October 2011. All participants were treated using a standardised protocol for management of MBO which included parenteral hydration, dexamethasone 8 mg iv/sc mane + midi, anti‐emetics and/or antimuscarinics according to symptoms and analgesia. The intervention arm also received 100 mL of gastrografin administered orally by a nurse not associated with the study. (n = 4) The control arm received 100 mL of distilled water flavoured with aniseed oil in order to mimic the taste and smell of gastrografin, administered orally by a nurse not associated with the study. (n = 5) No specific time restrictions were instituted from enrolment to study drug administration (this was reported to occur in most cases within 6 hours).
Outcomes	Outcomes of interest to this Cochrane review ‐Efficacy of gastrografin in MBO, measured in days from administration to resolution of bowel obstruction (signified by passage of flatus or stool), length of stay and 30‐day readmission rates ‐ Tolerability and safety of gastrografin in MBO. Assessed using patient‐reported symptom and quality of life scores using the Edmonton Symptom Assessment System. Measurements were taken prior to the intervention and then at 30 minutes, 6 hours, 12 hours, 24 hours post intervention and then daily until day 14 or discharge. Outcomes not of interest to this Cochrane review ‐ Feasibility of a Phase III study using this protocol. Measured by the number of participants screened, enrolled and completing assessments over the 8‐month trial period.
Notes	The authors reported that they received no financial support for the research, authorship and/or publication of the article. The authors also declared no potential conflicts of interest with respect to the research, authorship, and/or publication of the article.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method used to generate sequence was not clearly stated
Allocation concealment (selection bias)	Low risk	Central randomisation was performed by the pharmacy who had no contact with the participants in the trial
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The study adequately described the blinding of both participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The study reports that it was blinded and described the use of identical 100 mL bottles with attempts to match the smell and taste of the placebo to that ofgastrografin by using aniseed oil
Incomplete outcome data (attrition bias) All outcomes	High risk	50% attrition rate for the intervention arm
Selective reporting (reporting bias)	High risk	Did not report data of their assessments of the tolerability and safety of gastrografin
Size of Study	High risk	Fewer than 50 participants in the intervention arm
Other bias	Low risk	No other bias suspected

MBO: malignant bowel obstruction; n: number of participants; iv: intravenous route of administration; sc: signifies subcutaneous route of administration