Comparison of Outcomes in Patients with Obesity Between Two Administration Routes of Omeprazole After Laparoscopic Sleeve Gastrectomy: An Open-Label Randomized Clinical Trial

Abstract

Background

The effect of different administration routes of omeprazole remains unclear on the recovery in patients with obesity after laparoscopic sleeve gastrectomy (LSG).

Methods

We designed a randomized clinical trial enrolling 120 patients with a BMI≥32.5 kg/m² after LSG. They were randomized into two groups to be administered with omeprazole by rapid intravenous injection (group A) or by continuous micropump infusion (group B). The plasma concentration of omeprazole was monitored upon initiating administration. Change in intragastric pH and gastrointestinal symptoms during follow-up served as indicators for therapeutic evaluation.

Results

Patients in the two groups showed no difference in the AUC curves (P=0.25), but group A had significantly higher peak concentration (P<0.001), and shorter time to reach peak concentration after administration (P<0.001), compared to group B. Before and after the administration of omeprazole, the average change in intragastric pH was much lower in group A (0.031 ± 0.61) than in group B (0.48 ± 0.74) (P=0.004). The incidence of gastrointestinal symptoms was similar between the two groups (P=0.85); however, the average duration of remaining symptoms was longer in group A (3.97 months; 95% CI, 2.90–5.04) than in group B (2.82 months; 95% CI, 2.01–3.63) (P=0.04).

Conclusion

Continuous micropump infusion of omeprazole may improve the outcomes in patients with obesity after LSG.

Trial registration

China Clinical Trial Registration Center (ChiCTR), ChiCTR-IPR-17013365. Registered 13 November 2017. http://www.chictr.org.cn/showproj.aspx?proj=22892.

Keywords:

• obesity
• laparoscopic sleeve gastrectomy
• omeprazole
• gastrointestinal symptoms

Acknowledgments

The study adheres to CONSORT guidelines.

Abbreviations

AUC, Area under the curve; BMI, Body mass index; Cmax, Peak concentration; LSG, Laparoscopic sleeve gastrectomy; PPI, Proton pump inhibitor; Tmax, Time to reach peak concentration after administration.

Data Sharing Statement

The datasets generated during and/or analyzed during the current study are not publicly available due to the privacy policy but are available from the corresponding author on reasonable request.

Ethics Approval

All procedures performed in studies involving human participants were in accordance with the Ethics Committee of the Shanghai Sixth People’s Hospital (approval No. 2017-132). Written informed consent was obtained from all individual participants included in the study. Our trial was conducted in accordance with the Declaration of Helsinki.

Author Contributions

WH and YL conceived and designed the study. YG, PZ, YH, and WH conducted the clinical trial. YG and QT performed the analysis and prepared the manuscript. YL and WH critically revised the manuscript. All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no competing interests.

Additional information

Funding

This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.