Ghrelin agonist TZP-101/ulimorelin accelerates gastrointestinal recovery independently of opioid use and surgery type: covariate analysis of phase 2 data

What Was Tested

Researchers studied Ghrelin in this randomized controlled trial publication.

The objectives of this analysis were to identify predictors of GI motility recovery in patients undergoing partial colectomy and to evaluate whether these factors affect ulimorelin acceleration of GI recovery.

Why It Was Studied

Delayed recovery of gastrointestinal (GI) motility is a common complication following surgery.

Who Took Part

According to the abstract, 236 patients were involved.

PubMed indexes the participants as teenagers, young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

Covariate analysis assessed the effect of eight variables-age, sex, body mass index, type of surgery (right colectomy, left colectomy, other), duration of surgery, blood loss, total opioid consumption, country-on recovery of GI motility in 236 patients randomized to ulimorelin (n = 168) or placebo (n = 68).

The primary endpoint was the recovery of GI function (time from the end of surgery to first bowel movement).

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

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

Blinding on both sides kept the patients and researchers unaware of who received Ghrelin.

Some patients received a placebo instead of Ghrelin, giving a reference point.

Stepwise regression identified a parsimonious model of the smallest subset of variables best predicting GI recovery.

What Was Measured

Delayed recovery of gastrointestinal (GI) motility is a common complication following surgery.

Topics PubMed links to this paper include Analgesics, Opioid, Colectomy, Gastrointestinal Agents, Gastrointestinal Motility, Ghrelin, Macrocyclic Compounds and Multivariate Analysis.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Ghrelin in 236 patients.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2012 (World journal of surgery), a journal based in United States.

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