Randomized double-blind placebo-controlled trial of early octreotide in patients with postoperative enterocutaneous fistula

What Was Tested

This randomized controlled trial paper looks at Octreotide.

Somatostatin and octreotide both enhance closure of gastrointestinal fistulas.

Thirty-one patients with post-operative gastrointestinal or pancreatic fistula were randomly assigned to receive parenteral nutrition plus octreotide (14 patients) or placebo (17) within 8 days of fistula onset.

Who Took Part

According to the abstract, 14 patients were involved.

The age groups tagged for this paper are middle-aged adults and older adults, both men and women.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Octreotide could be set against what happens without it.

The methods mention a period of 8 days.

What Was Measured

Somatostatin and octreotide both enhance closure of gastrointestinal fistulas.

Thirty-one patients with post-operative gastrointestinal or pancreatic fistula were randomly assigned to receive parenteral nutrition plus octreotide (14 patients) or placebo (17) within 8 days of fistula onset.

The subject headings attached to it are Cutaneous Fistula, Intestinal Fistula, Octreotide, Pancreatic Fistula, Parenteral Nutrition and Postoperative Care.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Octreotide in 14 patients over 8 days.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 1995 (The British journal of surgery), a journal based in England.

More context: the Octreotide compound page, all human trials.