The effect of remote ischemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial

ABSTRACTBackgroundCardiac and inflammatory biomarkers have been associated with adverse outcome after major abdominal surgery. Remote ischemic preconditioning (RIPC) may protect organs from ischemic insults during and after cardiac surgery, but the effect in major abdominal surgery is largely unknown.ObjectiveTo study the effect of RIPC on cardiac and inflammatory biomarkers in patients undergoing pancreatic resection.MethodsSingle-center, double-blind, randomized controlled trial in ninety patients undergoing elective pancreatic resection between March 2017 and February 2019. Three cycles of upper-limb ischemia and reperfusion (each 5 minutes) were applied before surgery. The primary endpoint was the maximum postoperative high-sensitive cardiac troponin (hs-cTn) T concentration within 48 hours after surgery. Secondary endpoints were postoperative myocardial injury (PMI, defined as a postoperative hs-cTnT ≥14 ng L-1), the maximum concentration of interleukin (IL)-6 within 48 hours after surgery, and postoperative complications within 30-days of surgery.ResultsRIPC did not reduce the maximum hs-cTnT concentration after surgery (12.6 ng L-1 vs 16.6 ng L-1 in the control group (P=0.23), nor did it lessen the incidence of PMI (15 (33.3%) patients in the RIPC group versus 19 (42.2%) controls, P=0.93). The maximum postoperative IL-6 concentration was 239 pg mL-1 [115-360] in the RIPC group, as compared to 317 pg mL-1 [174-909] in the control group (P=0.13). A postoperative complication occurred in 23 (51%) RIPC patients and 24 (53%) controls.ConclusionsRemote ischemic preconditioning did not reduce the maximum postoperative hs-cTnT concentration. Postoperative myocardial injury, IL-6 concentrations and postoperative complications were not statistically different between RIPC patients and controls.Trial RegistrationClinicaltrials.gov identifier NCT03460938FundingFunding for biomarker analysis was provided by Roche Diagnostics. Roche Diagnostics had no role in design and conduct of the study, analysis and interpretation of the data, preparation and approval of the manuscript.Article summaryStrengths and limitations of this studyWell-designed clinical trial in a selected group of high-risk abdominal surgery patients.Serial assessment of high-sensitive cardiac troponin T and interleukin-6 concentrations.Postoperative cardiac biomarker concentrations were relatively low.This trial was not primarily designed to detect differences in IL-6 concentrations and postoperative complications.

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Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

10.21203/rs.3.rs-660427/v1 ◽

2021 ◽

Author(s):

Yuyan Wu ◽

Jinxuan Lin ◽

Haiping Zeng ◽

Yi Chen ◽

Zhiqiang Chen ◽

...

Keyword(s):

Postoperative Complications ◽

Abdominal Surgery ◽

Controlled Trial ◽

Controlled Study ◽

Chewing Gum ◽

Control Group ◽

Gastrointestinal Function ◽

Blank Control Group ◽

Randomized Controlled ◽

Significant Difference

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.

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