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