Randomized Clinical Trial of Itopride for the Treatment of Postoperative Ileus after Laparoscopic Cholecystectomy

Publisher： Karger

E-ISSN： 2297-475x|20|1|61-65

ISSN： 2297-4725

Source： Visceral Medicine (formerly: Viszeralmedizin), Vol.20, Iss.1, 2004-04, pp. : 61-65

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Previous Menu Next

Abstract

Background. Postoperative ileus is a distressing and frequent adverse effect after laparoscopic cholecystectomy (LCE). The goal of this prospective study was to evaluate if the new prokinetic drug itopride hydrochloride (Ganaton®, Abbott GmbH Co. KG, Wiesbaden, Germany) may ameliorate the gastric motility in the early post-operative period after LCE. Transcutaneous electrogastrography (EGG), a noninvasive diagnostic method allowing a monitoring of gastric myoelectric activity, was used to evaluate changes of gastric motility. Methods. 50 patients undergoing LCE were observed for 3 days beginning with the day of surgery. The patients were perorally treated with itopride hydrochloride (50 mg per day) or placebo (sacharose) in a randomized double-blind manner. EGG records were done 6, 24, and 48 h after surgery. EGG was performed in a fasting state and after stimulation with a liquid bolus. The EGG data were recorded by a Microdigitrapper device and analyzed using spectral analysis and Fourier transformation. Results. When comparing both groups (itopride and placebo), nausea was found significantly more frequently in the placebo group at the day of surgery as well as on postoperative days 1 and 2. The incidence of vomiting did not differ between both groups. Moreover, there are some differences in the EGG records. On the day of surgery, 40 and 56% of the patients in the placebo and the itopride group showed a physiological EGG curve, respectively. On the 1st postoperative day it was 56 and 68% and on the 2nd postoperative day 80 and 88%. However, these differences failed to reach a significance level of p < 0.05, most likely because of the relative small group sizes. Conclusion. The perioperative use of itopride accelerates the normalization of the EGG curve after LCE. Itopride was well tolerated, and we did not observe serious adverse effects during therapy. Our data suggests that itopride can be a useful accelerator of postoperative ileus restoration after LCE. However, other studies will be necessary to unequivocally prove the beneficial effect of itopride after LCE also in comparison with other commonly used drugs.