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Randomized Controlled Trial
Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study.
- Brij B Agarwal, Juhil D Nanavati, Nayan Agarwal, Naveen Sharma, Krishna A Agarwal, Kumar Manish, Satish Saluja, and Sneh Agarwal.
- Department of General and Laparoscopic Surgery, Ganga Ram Institute of Post Graduate Medical Education and Research (GRIPMER), New Delhi, India. endosurgeon@gmail.com.
- Surg Endosc. 2016 May 1; 30 (5): 1733-41.
ObjectiveUse of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular footprint in an index LS, i.e., laparoscopic cholecystectomy (LC).Methods And ProceduresThis RCT was conducted in collaboration with tertiary-level institutions, from January 2014 to December 2014 with institutional review board clearance. Consecutive, unselected, consenting candidates for LC were randomized (after anesthesia induction) into group I (ED) and group II (non-ED). They were managed with compliance to universal protocols for ethics, informed consent, anesthesia, drug usage and clinical pathway with blinded observers. Biomolecular inflammatory markers, i.e., interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and highly sensitive CRP (HS-CRP), were measured with blood drawn juxta-preoperatively (H0), at 4 h (H4) and at 24 h (H24). The quantitative changes induced by ED on IL-6, TNF-α and HS-CRP at H0, H4 and H24 with their kinetic behavior were the study endpoint. Prospective data were analyzed statistically with a p value of <0.05 being significant.ResultsTwo cases from the ED group had biliary injury and hence were withdrawn from analysis. The ED (n = 49) and non-ED (n = 51) groups had similar demographic, clinical and H0 biomolecular variables. There was a significant increase in IL-6, TNF-α and HS-CRP from H0 to H4 in both the groups (p values <0.001). From H4 to H24, all three cytokines showed significant increase in ED group (p < 0.05), whereas in the non-ED group, IL-6 showed significant fall (p = 0.004) and TNF-α showed no significant change (p = 0.063). Both the groups showed H4-H24 elevation of HS-CRP (p = 0.000).ConclusionEnergized dissection adds to the cytokine-mediated postoperative inflammation. The additional ED-induced inflammation can be measured objectively by IL-6 and TNF-α levels.Clinical Trials RegistryClinical Trials Registry, India (REF/2014/06/007153).
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