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1.
Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial
Bajwa, M. S., Jackson, R., Dhanda, J., Tudur Smith, C., Shaw, R. J., Schache, A. G.
Cancers. 2023;15(20)
Abstract
OBJECTIVES High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. PATIENTS AND METHODS The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. CONTROL ARM ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index. RESULTS Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)). CONCLUSION The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).
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2.
Evaluation of the Efficacy of Magnesium Sulfate in Reducing Blood Loss in Functional Endoscopic Sinus Surgery: A Randomized Double-Blinded Controlled Trial
Preethi, A., Venkatraman, R., Karthika, U., Rangapriya, A.
Cureus. 2023;15(5):e38636
Abstract
Objectives The primary concern in functional endoscopic sinus surgery (FESS) is maintaining a clear and unobstructed surgical field. Achieving this objective necessitates controlled hypotension, which can aid in the surgical dissection process and reduce the overall duration of the operation. This study aims to evaluate the efficacy of a sole bolus injection of intravenous magnesium sulfate in FESS. The outcomes measured include blood loss, surgical field grading, the additional intraoperative requirement of fentanyl, stress attenuation during laryngoscopy and endotracheal intubation, and extubation time. Methods In this prospective, double-blinded, randomized control trial (CTRI/2021/04/033052), 50 patients scheduled for FESS were randomly divided into two groups: Group M received 50 mg/kg MgSO(4) in 100 ml normal saline, and Group N received 100 ml plain normal saline 15 min before induction. The study assessed total blood loss, measured by blood collected from the surgical field and weighing gauze. The surgical field grading was assessed by a six-point Fromme and Boezaart scale. We also observed stress attenuation during laryngoscopy and endotracheal intubation, additional intraoperative fentanyl requirements, and time taken for extubation. The sample size was estimated using the G power calculator 3.1.9.2 (http://www.gpower.hhu.de/). Data were entered in Microsoft Excel (Microsoft Corporation, Redmond, WA) and analyzed using Statistical Package for Social Sciences version 20.0 (IBM Corp., Armonk, NY). Results The demographic data and duration of the surgery were comparable in both groups. The total blood loss in Group M was 100.40 ml ±60.71 ml, which is lower than Group N (133.80 ml ±59.7 ml) with a p-value of 0.016. In addition, the surgical field grading was also better in Group M. The total vecuronium consumption was significantly lower in Group M, which was (7.23±0.84 mg); in Group N, it was (10.64±1.74 mg) with a p-value of 0.0001, respectively. The dosage of additional fentanyl in Group N was 38.46 mcg ± 8.99 mcg, more than in Group M (33.64 mcg ± 11.20 mcg). The time required for extubation was similar in both groups. The duration of the surgery was significantly more significant in Group M (150.0 ±31.36) than in Group N (205.0 ±32.79), with a p-value of 0.0001, respectively. Furthermore, the mean arterial pressure after induction, at 2 min and 4 min after laryngoscopy, was less in Group M, with p=0.001, p=0.003, and p<0.0001, respectively, when compared with Group N. The heart rate after induction, at 2 min and 4 min after laryngoscopy, was also less in Group M, with p=0.016, p=0.003, and p=0.003, respectively, when compared with Group N. The Ramsay Sedation Score was higher in Group M than in Group N's fourth, eighth, and sixteenth hour, with p=0.001, p=0.021, and p=0.001, respectively, in the postoperative period. The sedation score was statistically insignificant after that. No complications were encountered during the study. Conclusion We conclude that a single bolus dose of MgSO(4) reduced surgical blood loss more effectively than in the control group. The surgical field grading was also better in Group M, as was the stress attenuation during laryngoscopy and endotracheal intubation. The intraoperative fentanyl requirement was not statistically significant. The time for extubation was similar between the groups. No other adverse effects were encountered during the study.
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3.
Efficacy of Continuous Suctioning in Adenoidectomy Haemostasis-Clinical Study
Epure, V., Hainarosie, R., Gheorghe, D. C.
Medicina (Kaunas, Lithuania). 2023;59(9)
Abstract
Introduction: Adenoidectomy is often the first major surgical challenge for the child's haemostatic system, and controlling intraoperative bleeding can be a challenge for the surgeon. Different methods have been used intraoperatively by surgeons in order to enhance haemostasis. The cold air effect (continuous suctioning) has been used by some surgeons during adenoidectomy; however, no documentation of its haemostatic effect has been made. Objectives: Our prospective randomised controlled study enrolled a sample of 140 children undergoing adenoidectomy, and we studied the effect of continuous suctioning on the duration of haemostasis in paediatric adenoidectomy. Materials and Methods: We evaluated the effect of using continuous suctioning during haemostasis at the end of adenoidectomy procedures, comparing variables such as total surgery time, total haemostasis time, and intraoperative blood loss, between two groups: 70 adenoidectomy procedures where no continuous suctioning was used to enhance haemostasis versus the other 70 patients where continuous suctioning was the haemostatic method employed. RESULTS After statistical analysis of the recorded data, we found that the total duration of adenoidectomy, the duration of haemostasis in adenoidectomy, and the intraoperative blood loss were significantly lower in patients in whom cold air was used for haemostasis. Intraoperative haemostasis failure (and consequent use of electrocautery for haemostasis) was more frequent in patients in whom no suctioning was used; as for the rates of postoperative primary bleeding after adenoidectomy, they were similar in both groups of patients, regardless of the technique used for haemostasis. Conclusions: The use of continuous suctioning during adenoidectomy haemostasis significantly shortens total surgical and haemostasis time, reduces intraoperative blood loss, and reduces the incidence of haemostasis failure (with the consequent need for bipolar electrocautery haemostasis).
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4.
Surgiflo® hemostatic matrix versus NasoPore® nasal packing following postassium titanyl phosphate laser surgery for hereditary hemorrhagic telangiectasia: A randomized controlled trial
Pyne JM, Murray S, Kelly BC, Song JS, Rosvall BR, Côté DWJ
Laryngoscope investigative otolaryngology. 2023;8(2):328-334
Abstract
BACKGROUND To help ensure adequate hemostasis immediately following potassium titanyl phosphate (KTP) laser treatment, many centres treating hereditary hemorrhagic telangiectasia (HHT) routinely use nasal packing post-operatively. The purpose of this study was to compare hemostatic thrombin matrix with standard packing for postoperative bleeding, patient pain, and comfort. METHODS A prospective, randomized, double-blinded, non-inferiority study was conducted with participants at an HHT centre of excellence (COE) and randomized to the treatment group with reconstituted thrombin gelatin matrix (Surgiflo®) or control group with a biodegradable synthetic polyurethane foam (NasoPore®). Adult subjects with confirmed HHT and moderate to severe epistaxis (a minimum calculated epistaxis severity score [ESS] of 4.0) warranting KTP laser treatment were recruited. Data was collected 2 weeks post operatively by a blinded reviewer completing a visual outcomes evaluation and each patient completing a subjective symptoms questionnaire. Non-parametric statistical analysis was employed. RESULTS Twenty-eight adult patients were randomized to the treatment and control arms with comparable preoperative epistaxis severity scores. Postoperative nasal bleeding was equivalent. Significantly less pain was found in the treatment arm (p = .005). While there were trends towards less obstruction and increased satisfaction in the treatment group as well as less crusting in the control group, these findings were not statistically significant. Allocation to the treatment group was associated with an approximately $75 higher cost. CONCLUSIONS When compared to NasoPore® for hemostasis, Surgiflo® hemostatic matrix performed equivalently while causing less discomfort in HHT patients following nasal KTP treatment. LEVEL OF EVIDENCE 1b.
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5.
Randomized Comparative Study of Microwave Ablation and Electrocautery for Control of Recurrent Epistaxis
Lou, Z. C., Jin, K. F.
Ear, Nose, & Throat Journal. 2021;100(7):509-515
Abstract
OBJECTIVE To compare the outcomes of adult patients with recurrent epistaxis treated intraoperatively with either bipolar electrocautery or microwave ablation (MWA). STUDY DESIGN Prospective randomized control study. MATERIALS AND METHODS One hundred ten patients with idiopathic recurrent epistaxis who met the inclusion criteria were randomly assigned into MWA group and bipolar electrocautery group. Primary outcomes were the proportion of patients in each group whose bleeding had stopped within 24 hours after treatment and time to achieve successful hemostasis. Secondary outcomes were the rebleeding rate after 3 days, 1 and 12 weeks, and 6 months and complications. RESULTS Successful immediate arrest of epistaxis was achieved in all patients. The times to achieve successful hemostasis were 2.13 ± 1.04 minutes in the MWA group and 6.60 ± 2.68 minutes in the bipolar electrocautery group (P = .000). The rates of recurrent bleeding were similar in patients treated with the different approaches (P = .231). However, secondary crusting was observed endoscopically in 59 patients in the bipolar electrocautery group, while pseudomembrane of the ablation zone was seen in 19 (36.5%) patients in the MWA group. Nevertheless, there were no severe postoperative complications, including septal perforation and orbit and brain complications, in either group at the 6-month follow-up. CONCLUSION Bipolar electrocautery and MWA had similar outcomes for the treatment of adult patients with recurrent epistaxis. However, MWA resulted in rapid hemostasis with less local nasal pain and less crust. Thus, MWA could be a favorable treatment option for patients with idiopathic recurrent epistaxis.
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6.
To evaluate the role of Feracrylum (1%) as hemostatic agent in Tonsillectomy
Valse D, Hosalli Kumaraswamy N
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India. 2021;73(2):240-245
Abstract
Tonsillectomy is a common procedure performed globally. It is associated with morbidities like hemorrhage and pain. Various methods are employed to reduce them. The present study is aimed to evaluate the role of Feracrylum (1%) in traditional cold steel tonsillectomy and to measure the outcomes in terms of intra-operative bleed, intra-operative time and post operative pain and recovery. A prospective study was conducted in Department of ENT, ESI Medical College, Kalburgi Karnataka, India, for a period of two years between January 2019 to December 2020 In this study, a total of 60 patients were involved and divided them into two groups after fulfilling the inclusion and exclusion criteria. Thirty patients each undergoing tonsillectomy with the use of Feracrylum considered as Group I and without the use of Feracrylum in the tonsillar fossae considered as Group II. The study has been approved by Ethics committee and informed consent was obtained from all the study subjects. The amount of blood loss is calculated. Post operative pain based on VAS (Visual Analogue Scale) is assessed in both the groups. Assessment of recovery in days is estimated in both groups by reduced pain, gaining normal activity and normal food intake. In this study, intra-operative time in group I was 19.83 ± 3.93 min and in group II 27.16 ± 3.35 min (P < 0.001). The intra-operative blood loss in group I was 26.67 ± 4.81 ml and in group II 44.70 ± 7.59 ml (P < 0.001). Patients recovered from pain, resumed normal activity and food intake within 2-3 days in Group I and in contrast it took about 3-5 days on an average in group II. In this study, majority of the patients experienced mild pain in Group I when Feracrylum was used during hemostasis. In our study, the time taken by the patients to recover from pain, resume their normal activity and also with regard to normal food intake was rapid. On an average of 2-3 days was seen in Group I. Group II patients required 3-5 days to recover from pain and resuming normal activity and food intake. The P value of < 0.001 was highly significant. Our study has stressed that use of Feracrylum in cold steel tonsillectomy is relatively safe. Its use is associated with a significant decrease in surgical time and blood loss. Rapid recovery makes it favourable to be used in cold steel tonsillectomy.
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7.
Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT
Borgstrom A, Nerfeldt P, Friberg D
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2019
Abstract
PURPOSE Our previous randomized controlled trial (RCT) of children with obstructive sleep apnea (OSA) showed no significant differences between adenotonsillectomy (ATE) and adenotonsillomy (ATE) in improving nocturnal respiration and symptoms after one year. This is the continuous report with the evaluation of postoperative morbidity concerning bleeding and pain. METHODS A double-blinded RCT including 79 children, aged 2-6 years, with moderate to severe OSA, randomized to either ATE (n = 40) or ATT (n = 39). From one to ten days postoperatively, parents filled in a logbook with six pain-related outcomes (parent and child grading pain at different levels, days of analgesic use and return to normal diet). Peri- and postoperative bleeding were also registered. RESULTS 63 patients (80%) returned the logbook. There were significant differences between groups in only two of the six pain-related outcomes in favor of the ATT group; first day when the children graded themselves as pain free (p = 0.021, Log Rank Test), and first day the caregiver estimated pain VAS ≤ 5 (p = 0.007, Log Rank Test). Two (5%) cases of postoperative bleeding occurred in the ATE group, one of which needed a return to theatre. No case of postoperative bleeding was seen in the ATT group. CONCLUSIONS The results from this RCT are in line with previous comparative studies between ATT and ATE. Children operated with ATT had significantly less postoperative pain in one-third of the outcomes, and less bleeding than ATE. However, as the differences in morbidity between the surgical methods were minor the clinical significance is uncertain. TRIAL REGISTRATION This study was approved by the Swedish Regional Ethics Board in Stockholm, Sweden (Dnr 2011/925-32 and 2013/2274-32) and registered at ClinicalTrials.gov (Trial registration number NCT01676181).
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8.
The Hemostatic Efficacy of Hydrogen Peroxide Irrigation to Control Intraoperative Bleeding in Adenoidectomy
Altun H, Hanci D, Kumral TL, Uyar Y
Turkish archives of otorhinolaryngology. 2018;56(4):193-198
Abstract
Objective: Although adenoidectomy is generally accepted as a safe procedure, intraoperative hemorrhage is still the most common and potentially life-threating complication, especially in pediatric patients. We evaluated the clinical effect of intraoperative hydrogen peroxide irrigation with respect to hemostasis and operation times in pediatric adenoidectomy. Methods: This was a prospective, randomized, double-blind study to investigate hydrogen peroxide solution in hemostasis in pediatric patients undergoing adenoidectomy. The patient, the surgeon, and the study nurse were blinded to the surgical technique used. Results: One hundred seventeen (56 males and 61 females) consecutive pediatric patients with a mean age of 5.46+/-1.19 years were included in the study. There were 58 patients in the hydrogen peroxide group (median age: 6 years, mean age: 5.62+/-1.28 years) and 59 patients in the control group (median age: 5 years, mean age: 5.31+/-1.07 years). No significant difference was observed between the two groups with respect to age (p=0.151), gender (p=0.646), or adenoid size (p=0.767). On the other hand, the difference between the groups with respect to operation and hemostasis times was found to be statistically significant (p<0.001 for both). The average operation times were 8.67+/-0.48 min in the hydrogen peroxide group and 12.30+/-0.69 min in the control group. The average hemostasis times were 3.67+/-0.27 min in the hydrogen peroxide group and 5.73+/-0.31 min in the control group. Conclusion: Hydrogen peroxide solution can be effectively used in adenoidectomy for reducing intraoperative blood loss and for economic benefits.
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9.
Effect of bougie-guided nasal intubations upon bleeding: a randomised controlled trial
Vadhanan P, Tripaty D K
Turkish Journal of Anaesthesiology and Reanimation. 2018;46((2)):96-99.
Abstract
Objective: Bleeding due to inadvertent trauma is a troublesome complication of nasal intubations. A lot of methods have been suggested to minimise this problem. A flexible bougie can be passed atraumatically via the nasal route to the trachea and an appropriate-sized endotracheal tube can be railroaded over it to avoid this problem. The primary objective of the study was to compare the severity of bleeding with bougie-guided and conventional nasotracheal intubations on a subjective scale. The time taken for successful intubations and the number of attempts required were also noted. Methods: This randomised controlled study was performed in 40 adult patients requiring nasotracheal intubations for various elective surgeries over a 3-month period in a teaching hospital. The patients after satisfying the inclusion criteria were randomised into two groups of 20 each: Bougie-guided (Group B) and Not Bougie-guided (Group NB). Group B patients were intubated by railroading the endotracheal tube over a flexible bougie, and Group NB patients were intubated conventionally without the bougie. The degree of bleeding was noted on a subjective scale as nil, mild, moderate or severe. The time taken for intubation in seconds and the number of attempts taken were noted. The degree of bleeding was compared using Mann-Whitney U test, and the time taken for intubation was compared using the Student's t test after assessing normalcy. An alpha error of 5% was used, and p values less than 0.05% were considered significant. Results: All patients randomised completed the study. The degree of bleeding was lesser in the Bougie-guided group than in the conventional group (p=0.02), and the time taken for intubation was longer in the bougie-guided group (p<0.01). Conclusion: Using a bougie routinely for nasal intubations might minimise trauma during nasal intubations but increase the time taken for intubation marginally. The success rates for intubations may also be better.
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10.
Management of persistent epistaxis using Floseal hemostatic matrix vs. traditional nasal packing: a prospective randomized control trial
Murray S, Mendez A, Hopkins A, El-Hakim H, Jeffery CC, Cote DWJ
Journal of Otolaryngology - Head & Neck Surgery = Le Journal D'oto-Rhino-Laryngologie Et De Chirurgie Cervico-Faciale. 2018;47((1)):3.
Abstract
BACKGROUND Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal(R) (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal(R) (Baxter, USA) compared to traditional nasal packing for persistent epistaxis. METHODS A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal(R) (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed. RESULTS There were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p = 1.000), requirement for admission (15.4% vs. 46.1%, p = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p = 0.2016). Floseal(R) (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p = 0.0022), treatment (0.50 vs. 4.46, p = 0.0007) and removal (0 vs. 3.85, p = 0.0021). Floseal(R) (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal(R) has >90% chance of not only being cost-effective, but the dominant (preferred) treatment. CONCLUSIONS Floseal(R) (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile. TRIAL REGISTRATION Trial registration number: NCT02488135 . Date registered: June 26, 2015.