Effect of topical tranexamic acid on bleeding and quality of surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a triple blind randomized clinical trial.
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ABSTRACT: Background
The effect of tranexamic acid (TXA) on bleeding and improvement of surgical field during functional endoscopic sinus surgery (FESS) is not clear yet. This study was conducted to answer this question.Methods
This trial was conducted on 60 patients with chronic sinusitis at Beasat Hospital, Hamadan, Iran, from April to November 2013. Thirty patients in the intervention group received three pledgets soaked with TXA 5% and phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery. Thirty patients in the control group received phenylephrine 0.5% with the same way. The amount of bleeding and the quality of surgical field were evaluated at 15, 30, and 45 minutes after the start of surgery using Boezaart grading.Results
The quality of the surgical field in the intervention group compared to the control group was significantly better in the first quarter (P?=?0.002) and the second quarter (P?=?0.003) but not in the third quarter (P?=?0.163). Furthermore, the amount of bleeding was much less during all periods in the intervention group than in the control group (P?=?0.001).Conclusion
Topical TXA can efficiently reduce bleeding and improve the surgical field in FESS in patients with rhinosinusitis. Based on these findings, topical TXA may be a useful method for providing a suitable surgical field during the first 30 minutes after use.Trial registration
Iranian Registry of Clinical Trials IRCT201212139014N15.
SUBMITTER: Jahanshahi J
PROVIDER: S-EPMC4136784 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPsychological dysfunction is highly prevalent among patients with chronic rhinosinusitis (CRS). Previous study has identified various measures of anxiety and depression as predictors of quality-of-life outcomes following endoscopic sinus surgery (ESS). Psychological dysfunction scores, as measured by the 22-item Sino-Nasal Outcome Test (SNOT-22), have been found to influence treatment decision making in CRS. This study aims to further elucidate improvement in discrete psychological symptoms following ESS for CRS.MethodsAdult patients with medically recalcitrant CRS electing to undergo ESS were prospectively enrolled into a multi-institutional, observational cohort. Psychological-related symptom severity and postoperative outcomes were assessed using psychological domain items of the SNOT-22, including subgroup analysis of patients with and without comorbid depression.ResultsA total of 374 participants met inclusion criteria and were followed postoperatively for a mean ± standard deviation (SD) of 14.6 ± 5.0 months. Total mean psychological domain scores improved from 15.9 ± 8.2 to 8.5 ± 8.4 (p < 0.001). Significant relative mean improvements were reported in "waking up tired" (23%; p < 0.001), "fatigue" (25%; p < 0.001), "reduced productivity" (28%; p < 0.001), "reduced concentration" (27%; p < 0.001), " frustrated/restless/irritable" (27%; p < 0.001), "sad" (15%; p < 0.001), and "embarrassed" (8%; p < 0.001) scores. A total of 64% to 66% of participants reported improvement in "reduced productivity," "waking up tired," "fatigue," and "frustrated/restless/irritable," compared to 46% and 38% reporting improvement in "sad" and "embarrassed," respectively.ConclusionPatients with CRS report significant improvement in common mental health-related symptoms following ESS. Despite these improvements, some degree of persistent postoperative psychological dysfunction was reported. Further study is necessary to determine which factors are associated with persistent psychological dysfunction after ESS in order to optimize treatment outcomes.
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Project description:ImportancePatient-reported measures are designed to detect a true change in outcome, but they are also subject to change from biases inherent to self-reporting: changing internal standards, changing priorities, and changing interpretations of a given instrument. These biases are collectively known as "response shifts" and can obscure true change after medical interventions.ObjectiveTo determine the presence of response shifts in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery.Design, setting, and participantsMultisite, prospective, observational cohort study conducted at academic tertiary care centers between February 2011 and May 2013. Study participants comprised a population-based sample of 514 adults (age ≥18 years) with CRS, who elected surgical intervention for continuing medically refractory symptoms.InterventionEndoscopic sinus surgery.Main outcomes and measuresPreoperative and postoperative data from the 22-item Sinonasal Outcome Test (SNOT-22) survey instrument was characterized using exploratory factor analysis. Subsequent longitudinal structural equation models were estimated to test structure, potential response shifts, and true change in the SNOT-22 scores.ResultsA total of 339 participants (66.0%) provided survey evaluations at baseline and 6-month follow-up. Factor analysis of the SNOT-22 revealed 5 correlated, yet distinguishable, underlying factors. Endoscopic sinus surgery had a differential impact across these factors, with the largest effect size in rhinologic symptoms (mean [SD] SNOT-22 scores before and after surgery, 13.18 [5.11] and 7.37 [5.48], respectively; d = -1.13 [P < .001]) and extranasal rhinologic symptoms (8.31 [3.46] and 4.83 [3.68], respectively; d = -1.00 [P < .05]) (d is an effect size measure defined as the difference in means divided by the presurgery SD). Endoscopic sinus surgery had a smaller, yet significant, effect size on the remaining 3 factors: ear/facial symptoms (7.32 [4.6]) and 3.90 [4.07], respectively; d = -0.74 [P < .001]), psychological dysfunction (11.90 [7.21] and 6.50 [6.69], respectively; d = -0.75 [P < .05]), and sleep dysfunction (10.12 [5.59] and 5.88 [5.37], respectively; d = -0.76 [P < .001]). Participants were found to undergo recalibration, reprioritization, and reconceptualization of symptoms after intervention; however, the magnitude of these response shifts was small and not clinically significant.Conclusions and relevanceThe SNOT-22 measures 5 distinct factors, not a single construct. Reporting of individual subscale scores may improve sensitivity of this instrument in future studies. Participants undergoing endoscopic sinus surgery experience only clinically insignificant response shifts, validating assessment of change through use of presurgery and postsurgery SNOT-22 responses.Trial registrationclinicaltrials.gov Identifier: NCT01332136.
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