Surgiflo® hemostatic matrix versus NasoPore® nasal packing following postassium titanyl phosphate laser surgery for hereditary hemorrhagic telangiectasia: A randomized controlled trial
Laryngoscope investigative otolaryngology. 2023;8(2):328-334
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.
The use of fibrin glue in pterygium surgery with amniotic membrane transplantation: Systematic review and meta-analysis
Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological Society. 2023;37(2):83-89
PURPOSE To compare the outcomes of fibrin glue versus sutures in pterygium surgery with amniotic membrane transplantation. METHODS A systematic review and meta-analysis were performed as per the Preferred Reporting Items for Systematic Reviews and Meta-analyses Guidelines. An electronic search identified all studies comparing the outcomes of using fibrin glue versus sutures in pterygium surgery with amniotic membrane transplantation. Conjunctival inflammation, postoperative pain and discomfort, pterygium recurrence, pyogenic granuloma, and surgical time were primary outcome measures. Secondary outcome measures included amniotic membrane transplant outcomes, time to recurrence, graft loss, and subconjunctival hemorrhage. Fixed and random-effects models were used for the analysis. RESULTS Four studies enrolling 180 patients were identified. Conjunctival inflammation (odds ratio [OR] 0.21, P = 0.0005) demonstrated a significant difference favoring the fibrin glue group. Despite the trend favoring the use of fibrin glue, there were no significant differences in terms of postoperative pain and discomfort (OR = 0.46, P = 0.25), pterygium recurrence (OR = 0.74, P = 0.48), pyogenic granuloma (OR = 0.47, P = 0.38), and surgical time (mean difference = -17.52, P = 0.13). For secondary outcomes, fibrin glue had significantly fewer cases of graft loss compared with sutures. No statistically significant difference was found in amniotic membrane graft outcomes, time to recurrence, and subconjunctival hemorrhage. CONCLUSION Fibrin glue is comparable to the sutures used in pterygium surgery with amniotic membrane transplantation as it significantly improves conjunctival inflammation and does not increase postoperative pain and discomfort, pterygium recurrence, pyogenic granuloma, and surgical time.
Autologous fibrin glue versus sutures for conjunctival autograft in primary pterygium: a randomized clinical trial
International ophthalmology. 2023
PURPOSE To describe and compare the autologous fibrin glue and traditional sutures for conjunctival graft attachment in patients undergoing primary pterygium excision surgery. METHOD A randomized clinical trial included patients who underwent pterygium surgery with conjunctival autologous graft (CAG). Using randomization, a single-trained surgeon performed graft fixation with autologous glue or sutures. The glue was prepared immediately before the surgery, using the patient's blood components. After centrifugation, the plasma was collected and enhanced with calcium gluconate. Postoperative assessments were performed on Days 1, 7, 21, 30 and 180. The study evaluated postoperative edema and pain and complications. The mean surgical time was compared. Recurrence of the pterygium was assessed 6 months postoperatively. RESULTS The study evaluated 61 eyes. Thirty-three eyes underwent pterygium surgery using the glue technique, and 28 underwent the traditional suture technique. Fifty-one patients (83.60%) had successful graft adhered to at the end of follow-up. Ten patients (10/33) lost their graft in the glue group, and only 69.70% maintained graft presence in the fourth week versus 100% of the patients in the suture group (p = 0.001). Pain scores were lower in the glue group, and clinical edema was significantly higher. There was no significant difference in graft retraction or the presence of granuloma, necrosis or postoperative infection. CONCLUSION Autologous fibrin glue is an affordable option for CAG fixation in particular contexts where commercial fibrin glue is unavailable, and it could offer advantages compared to sutures. A higher graft loss rate was observed and might be related to topical anesthesia, and improvements to the technique are needed. CLINICALTRIALS gov Identifier: NCT04151017. https://clinicaltrials.gov/ct2/show/NCT04151017?term=20170467&draw=1&rank=1 .
Efficacy of Continuous Suctioning in Adenoidectomy Haemostasis-Clinical Study
Medicina (Kaunas, Lithuania). 2023;59(9)
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).
Evaluation of the Efficacy of Magnesium Sulfate in Reducing Blood Loss in Functional Endoscopic Sinus Surgery: A Randomized Double-Blinded Controlled Trial
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 126.96.36.199 (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.
Complications of revision surgery in case of bleeding after thyroid surgery: A systematic review
European annals of otorhinolaryngology, head and neck diseases. 2023
OBJECTIVES The aim of this review is to evaluate complications in patients undergoing surgical control of bleeding after thyroid surgery. Secondly, we have analyzed the rate of the main complications. METHODS The databases PubMed and EMBASE were searched for articles regarding complications after revision thyroid surgery for bleeding. A Systematic review methodology based on Preferred Reporting Items for Systematic Reviews and Meta-analysis was performed. RESULTS Nine studies met the inclusion criteria, six are retrospectives and three retrospectives controlled. The overall rate of bleeding after thyroid surgery was 1.38%. In these patients, the most common complication after revision surgery for bleeding is hypoparathyroidism 24.9% (95% CI: 20.7-29.5) followed by recurrent laryngeal nerve injury 8.1% (95% CI: 6.4-10.1) and wound infection 4.5% (95% CI: 2.5-7.6). Tracheostomy and other lethal complications are rarely described. CONCLUSION Although rare, complications after surgical control of bleeding in patients undergoing thyroid surgery can be serious. Therefore, in order to optimize the surgical outcomes, standardized protocol providing early detection and precise hemostasis procedure, is needed. Specific patient-informed consent for this condition should be created.
Results of Fibrin Glue Applied Over the Corneal Surface Immediately After Pterygium Surgery: A Novel Pain Relief Technique
PURPOSE The aim of this study was to compare the use of fibrin glue on the corneal epitheliectomy site at the end of pterygium surgery versus conventional eye patch regarding pain levels, need for oral analgesic medications, number of days feeling pain, and awakening due to pain after surgery. METHODS Forty-eight eyes of 24 patients with bilateral primary pterygium were included in this prospective, randomized, double-masked controlled trial. Each eye of the same patient was randomized to the intervention or control group. The intervention group received 2 drops of fibrin glue in the epitheliectomy site at the end of surgery and an eye patch, whereas the control group was only received an eye patch. Patients returned on the first and seventh days after surgery. Pain intensity (measured using the visual pain analog scale), need for oral analgesics, the number of days the pain lasted, and quality of sleep were assessed during follow-up visits and compared between groups. Comparison analysis accounted for sex, age, pterygium grading, and comorbidities. RESULTS Visual analog pain scale after surgery was significantly lower in eyes receiving fibrin glue (-1.58; 95% confidence interval: -2.84 to -0.32; P = 0.014). In addition, the intervention group presented a 73% lower chance of using oral analgesics (OR: 0.27; 95% confidence interval: 0.07-0.95; P = 0.041). No difference in the awakenings at night was noted (P = 0.240) nor the mean days of ocular pain in the first week after surgery (P = 0.474). CONCLUSIONS Fibrin glue at the end of pterygium surgery effectively reduces pain and the need for oral analgesics compared with conventional eye patching. This study is the first to describe the results of this strategy.
The Impact of Surgical Indication on Posttonsillectomy Hemorrhage: A Systematic Review and Meta-Analysis
Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery. 2023
OBJECTIVE To investigate the impact of the surgical indication on posttonsillectomy bleed rates. DATA SOURCES PubMed, Scopus, CINAHL. REVIEW METHODS A systematic review was performed searching for articles published from the date of inception to July 6, 2022. English language articles describing posttonsillectomy hemorrhage rates in pediatric patients (age ≤ 18) stratified by indication were selected for inclusion. A meta-analysis of proportions with comparison (Δ) of weighted proportions was conducted. All studies were assessed for risk of bias. RESULTS A total of 72 articles with 173,970 patients were selected for inclusion. The most common indications were chronic/recurrent tonsillitis (CT/RT), obstructive sleep apnea/sleep-disordered breathing (OSA/SDB), and adenotonsillar hypertrophy (ATH). Posttonsillectomy hemorrhage rates for CT/RT, OSA/SDB, and ATH were 3.57%, 3.69%, and 2.72%, respectively. Patients operated on for a combination of CT/RT and OSA/SDB had a bleed rate of 5.99% which was significantly higher than those operated on for CT/RT alone (Δ2.42%, p = .0006), OSA/SDB alone (Δ2.30%, p = .0016), and ATH alone (Δ3.27%, p < .0001). Additionally, those operated on for a combination of ATH and CT/RT had a hemorrhage rate of 6.93%, significantly higher than those operated on for CT/RT alone (Δ3.36%, p = .0003), OSA/SDB alone (Δ3.01%, p = .0014), and ATH alone (Δ3.98%, p < .0001). CONCLUSION Patients operated on for multiple indications had significantly higher rates of posttonsillectomy hemorrhage than those operated on for a single surgical indication. Better documentation of patients with multiple indications would help further characterize the magnitude of the compounding effect described here.
Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial
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).
Comparative Study of Bipolar Electrocautery Versus Silk Ligation for Hemostasis During Tonsillectomy
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India. 2023;75(3):2025-2028
Tonsillectomy is a commonly performed surgery in otolaryngological practice. Owing to the possibility of postoperative bleeding, it is considered as one of the major surgical procedures. Various techniques have been advocated, however dissection and electrocautery are the most commonly used techniques in tonsillectomy. The objective was to study and compare the relative efficacy using two methods of tonsillectomy- bipolar electrocautery versus silk ligation. This prospective study included 50 patients who underwent tonsillectomy. Patients were randomly divided into two groups. In Group A, left tonsillar fossa haemorrhage was controlled by ligation, while in Group B, bipolar diathermy was used to control bleeding of right tonsillar fossa. Comparison was done in terms of time taken for hemostasis, amount of intra-operative blood loss and post-operative pain. 130 (72.22%) male and 50 (27.77%) females were included. Group A included 20 cases while Group B included 30 cases. The mean time taken for hemostasis in Group A patients was 40.5 ± 4.4 min as compared to 25.3 ± 6.2 min in Group B patients. The mean blood loss on cautery side was 49.5 ± 4.5 ml and that on the ligation side was 68.6 ± 5.3 ml. Post-operative pain was significantly more in Group B patients as compared to Group A patients. Bipolar diathermy is a quicker and faster method to achieve hemostasis with little intraoperative blood loss as compated to silk ligation.