Abstract
Although absorbable nasal packings have been abundantly used in the recent time, the conventional packings are still used in different sinonasal surgeries in the various parts of the globe due to their lower cost. To compare the effectiveness of the balloon tamponade (Rapid Rhino) with Merocel nasal pack in sinonasal diseases. This study was conducted from July 2018 to July 2019 in a tertiary care referral hospital. Rapid Rhino and Merocel were put in 30 patients and 31 patients, respectively. Pain, bleeding, and mucosal healing was evaluated and compared between two groups postoperatively. The reduction in the pain and postoperative bleeding was significant with balloon tamponade (Rapid Rhino) compared to the Merocel (p < .05). Although insignificant (p > 0.05), patients with balloon tamponade nasal packs had less crusting and synechia in the postoperative period. Balloon tamponade (Rapid Rhino) nasal pack can be a better alternative to the Merocel nasal pack in reducing postoperative pain, bleeding, and mucosal damage.
Keywords: Balloon tamponade, Merocel, Sinonasal surgery, Outcomes
Introduction
Although absorbable nasal packings have been abundantly used in recent time, the conventional packings are still used in different sinonasal surgeries in the various parts of the globe due to their lower cost. Their primary role is to reduce postoperative bleeding in patients undergoing various sinonasal surgeries [1]. Although adequate hemostasis can be achieved in the intraoperative periods, they are not free of some inherent disadvantages, i.e., pain, bleeding, and mucosal damage, significantly contributing to the postoperative morbidity (scarring/synechia). Both ribbon gauze and Merocel (Medtronic Xomed, Jacksonville, Florida, USA) are the standard nasal packs used in the past in the sinonasal surgeries showing variable postoperative results [2]. Merocel (size 8 cm × 1.5 cm × 2 cm) is made up of hydroxylated polyvinyl acetate, which swells in the nasal cavity producing constant lateral pressure over the mucosal blood vessels to control the bleeding [3]. Keeping in mind the unavoidable complications attributed to the conventional nasal packs (ribbon gauze and Merocel), balloon tamponade (Rapid Rhino) can be effectively tried in sinonasal surgeries for a better clinical outcome in the postoperative period. Rapid Rhino (Arthrocare, Knaresborough, UK) consists of an inflatable balloon coated with carboxymethylcellulose (CMC), which promotes the clotting of blood by augmenting platelet aggregation besides its pressure effect [4]. Again, due to the lubricating effect of the CMC, it is relatively painless during insertion and removal of the pack. Because of the presence of the inflatable balloon, Rapid Rhino negotiates well in the nasal cavity, producing minimal injury to the mucosa in contrast to a Merocel. Hence the mucosal healing is supposed to be better in patients with Rapid Rhino nasal packs, producing less crusting and fibrosis than the conventional nasal packs. Despite the frequent use of Rapid Rhino in anterior epistaxis, its utility after the endoscopic sinus surgery is still not well described in the literature [5]. In the present study, we have compared the effectiveness of balloon tamponade (Rapid Rhino) and Merocel in endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis in reducing postoperative complications.
Materials and Methods
It was a randomized controlled study conducted in a tertiary care referral hospital from July 2018 to August 2019, and approval of the institutional ethical committee was taken prior to the study. Patients were randomized with the help of RANDOMIZER software, allocating them to either Balloon tamponade/Merocel groups. Based on the data from previous studies, taking power 95% and an alpha error of 5%, the sample size was calculated to be 64. Keeping the attrition rate at 10%, a total of 70 patients were included in the study (35 in each group). Patients of chronic rhinosinusitis with nasal polyposis were diagnosed based on the criteria proposed by the European Position Paper on Rhinosinusitis and Nasal Polyposis (CRSWNP) and all patients between 11 and 65 years old were included in the study [6]. Patients with unilateral nasal polyposis, less than 11 years old, and associated with systemic comorbidities like uncontrolled Diabetes mellitus, Hypertension, visual or motor impairments were excluded. The instruction for placing the nasal packs was given to the patients in sealed envelopes. Rapid Rhino and Merocel nasal packs were used in patients of group A and group B, respectively. Prior to the endoscopic sinus surgery, all the patients were ensured to get the uniform and the standard medical treatment in the form of inhalational nasal steroids for 6 weeks, oral antihistaminic for 15 days and systemic antibiotics for 7 days before admission. Again, the systemic antibiotic was continued for 7 days after the surgery and the inhalational steroid was started 7 days after the surgery, which was continued for at least 6 weeks based upon the subjective response of the patient. Systemic Paracetamol (650 mg) was given to each patient in both the groups for 48 h in the postoperative period.
Before the surgery, written and informed consent was taken from each patient. A single surgeon performed all the surgical procedures under GA/LA, and the nasal packs were placed in both the nasal cavity after the endoscopic sinonasal surgery. Rapid Rhino was first soaked in the sterile water for 30 s, and then it was put gently in the middle meatus. It was then inflated with air until the pilot cuff becomes rounded. Similarly, Merocel was inserted into the nasal cavity, directing along the middle meatus, which was later irrigated with 10 ml of normal saline. After the nasal packings were placed in the nasal cavity, a dry bolster (previously weighted) was kept over the pack with the help of a micropore. All the packs were removed after 48 h of surgery, and patients were discharged after confirmation of hemostasis. Assessment of pain was calculated at 6 h and 48 h of surgery using the visual analogue scale (VAS). It was determined by measuring the distance (mm) on a 100 mm line between “no pain” and “severe pain”. The pain score was evaluated according to the scale; no pain (0–4 mm); mild pain (5–44 mm); moderate pain (45–74 mm); severe pain (75–100 mm). Similarly, the amount of blood loss is calculated in the immediate postoperative period (6 h after the surgery) by comparing the weight of the bolsters. The same procedure is repeated 48 h after the surgery after the removal of the nasal pack. Reactionary hemorrhage was assessed by the second author after the removal of the nasal pack (48 h) and ticked in the box according to the scale: 0 = no bleeding; 1 = bleeding stops after 3 min; 2 = bleeding stops with ice; 4 = requires repacking. Crusting and synechia were evaluated at the end of 2 weeks and 6 weeks in the postoperative period with a 0-degree rigid nasal endoscope.
Follow-Up
Patients were discharged after 48 h of surgery after the removal of the nasal packings. Follow-up visits were advised at the end of 2, 6, weeks after surgery. At each follow–up visit, nasal crusting and synechia were evaluated by Lund-Kennedy endoscopic scoring, i.e., 0 = absence; 1 = mild; 2 = severe degree of both crusting and scarring. The data obtained were recorded.
Statistical Analysis
Results were presented as n (%), mean, SD, Confidence Interval (CI). The quantitative data were compared using the t’ test, and the categorical data were compared with the Chi Square test. The level of significance was defined as p < 0.05. The data were collected using the software programs Microsoft Excel 2003 (Microsoft Corporation, New York, USA), and statistical analyses were performed using the Statistical Package for the Social Science version 20.0 for Microsoft Windows (SPSS Inc, Chicago, Illinois, USA).
Results
A total of 70 patients were enrolled in the study where either Rapid Rhino or Merocel nasal packs were placed after the surgery for various sinonasal diseases. Rapid Rhino was placed in patients of group A (containing 35 patients), and Merocoel was placed in group B (35 containing patients), respectively. Nine patients (5 from the Rapid Rhino group and 4 from the Merocel group) were lost in different follow-up periods; hence they were excluded from the final analysis. Of the total 61 patients, Rapid Rhino was applied in 30 patients (Group A), and Merocel was put in 31 patients (Group B) (Fig. 1 ). In group A, 18 patients were males, and 12 were female. Similarly, in group B, 21 patients were male, and 10 were females. The mean age of the patients in group A was 34 years (range 22–48), and in group B, it was 35 (26–52) years. The demographic data and patient characteristics have been shown in Table 1.
Fig. 1.
Study design
Table 1.
Demographic data and patient characteristics of the study population (n = 61)
| Characteristics | Group A (Rapid Rhino) (n = 30) | Group B (Merocel) (n = 31) |
|---|---|---|
| Number of procedures | 30 | 31 |
| Age (years) | 34 ± 12.13 | 35 ± 14.83 |
| Male (%) | 18 (60%) | 21 (67.74%) |
| Female (%) | 12 (40%) | 10 (32.25%) |
| Follow-up (months) | 08 (range 5–17) | 05 (range 3–11) |
| Duration of patients stay (days) | 2.47 ± 0.68 | 3.61 ± 5.31 |
The average follow-up period for group A patients was 8 months (range 2–20 months), and for group B, it was 5 months (3–11 months). All the patients in both groups had undergone functional endoscopic sinus surgery after the informed written consent. Septoplasty was performed as an adjunctive procedure in 11 patients of group A and 7 patients in group B. The unilateral and bilateral turbinoplasty was performed in 3 patients and 2 patients respectively in group A. Similarly, in group B, 4 patients underwent unilateral turbinoplasty and 2 patients underwent bilateral turbinoplasty. Bilateral maxillary, anterior–posterior ethmoidectomy was performed in all the patients in both groups. Sphenoidotomy was performed in 14 patients in group A 17 patients in group B. Similarly, the frontal recess was addressed in 5 patients in group A and 7 patients with B. There was no significant difference in the nasal pathology between the two groups (p > 0.05).
The mean VAS (visual analogue scale) score 6 h after the surgery was 1.97 ± 89 (range 0–4) in group A and 2.48 ± .92 (range 0–5) in group B, respectively. When the VAS score was compared between the two groups, the difference was found significant (p = 0.03) Fig. 2. Similarly, the mean VAS score at 48 h (during pack removal) was 0.09 ± 0.92 (range 0–4) and 1.32 ± 0.70 (range 0–4) in group A and group B, respectively (Table 2) and the difference was found to be significant (p = 0.04). Average blood loss 6 h after surgery was measured to be 2.69 ± 2.05 grams and 4.48 ± 1.61 g in group A and group B, respectively (p = 0.00). At 48 h, the mean blood loss in group A was 2.04 ± 1.41 grams, and in group B, it was found to be 4.04 ± 1.21 g (p = 0.00) Fig. 3. Reactionary hemorrhage was detected in 4 patients in group A and 13 patients in group B (p = 0.00), although none of the patients in any of the group required repacking. Nasal crusting and scarring/synechia were evaluated according to the Lund-Kennedy Endoscopic Scoring in the follow-up periods after 2 weeks and 6 weeks of surgery. At 2 weeks of surgery, 22 patients in group A had no crusting in the nasal cavity, 08 patients had mild crusting, and none of the patients had severe crusting. In group B, 07 patients did not have any crusting, 19 patients had minimal crusting, and 5 patients had severe crusting. The difference in crusting between the two groups was significant (p = 0.00). Similarly, 25 patients had no crusting, 05 patients had minimal crusting, in group A at 6 weeks of follow-up. In group B, 07 patients presented with no crusting, 18 patients had mild crusting and 06 patients had severe crusting, and the difference was found significant (p = 0.00). Again, at 2 weeks of the follow-up period, 19 patients presented with no scarring, 08 had minimal scarring, and 03 patients had severe scarring in group A. In group B, 10 patients presented with no scarring, 18 had mild scarring, and 03 patients had severe scarring at 2 weeks of follow-up (p = 0.03). Again at 6 weeks, 22 patients had no synechia, and 08 had mild synechia in group A and in group B, 14 patients had no synechia, 14 had mild synechia, and 03 had severe synechia (p = 0.04) Table 3. There was no significant correlation between the age of the patients and the VAS score at 6 h (r = 0.130, p = 0.32) and VAS score at 48 h (r = 0.76, p = 0.56). Furthermore, There was no significant correlation between the age of the patients and the amount of bleeding at 6 h (r = − .085, p = 0.51) or 48 h (r = 0.002, p = 0.98). The mean hospital stay of patients with Rapid Rhino and Merocel nasal pack were found to be 2.47 and 3.61 days, respectively, and no significant difference was detected between the two groups (p = 0.24).
Fig. 2.
Comparison of the VAS score between two groups at 6 h and 48 h of surgery
Table 2.
Comparison of pain and bleeding between Rapid Rhino and Merocel nasal pack after 6 and 48 h of surgery
| Characteristics | Rapid Rhino Nasal pack (n = 30) | Merocel nasal pack (n = 31) | P, 95% CI, SEM |
|---|---|---|---|
| Mean VAS score at 6 h | 1.97 ± .89 | 2.48 ± .92 | 0.03, CI (− .983.052), SEM = − 0.51 |
| Mean VAS score at 48 h | 0.90 ± .92 | 1.32 ± .70 | 0.04, CI (− .605 to .211), SEM = − 0 .42 |
| Average blood loss after 6 h (g) | 2.69 ± 2.05 | 4.48 ± 1.61 | 0.00, CI (− 2.73 to .83), SEM = − 1.78 |
| Average blood loss after 48 h (g) | 2.04 ± 1.41 | 4.04 ± 1.21 | 0.00, CI (− 2.67–1.32), SEM = − 2.00 |
VAS visual analogue scale, CI confidence interval, SEM standard error of mean
Fig. 3.
Comparison of postoperative bleeding between two groups at 6 h and 48 of surgery
Table 3.
Comparison of nasal crusting and synechia between Rapid Rhino and Merocel nasal packing in the follow-up periods
| Characteristics | Duration | Score | Rapid Rhino pack* pts (n) | Merocel pack† pts (n) | χ2, P value |
|---|---|---|---|---|---|
| Crusting | 2 weeks | 1 | 22 | 07 | 0.00 |
| 2 | 08 | 19 | |||
| 3 | 00 | 05 | |||
| 6 weeks | 1 | 25 | 07 | 0.00 | |
| 2 | 05 | 18 | |||
| 3 | 00 | 06 | |||
| Synechia | 2 weeks | 1 | 19 | 10 | 0.03 |
| 2 | 08 | 18 | |||
| 3 | 03 | 03 | |||
| 6 weeks | 1 | 22 | 14 | 0.04 | |
| 2 | 08 | 14 | |||
| 3 | 00 | 03 |
*n = 30, †n = 31, pts patients, score 1 = no, score 2 = mild, score 3 = severe
Discussion
Although different nasal packs have been used in various sinonasal surgeries in the past decades, an ideal pack should be hemostatic and painless both during insertion and removal of the pack with minimal damage to the nasal mucosal [7]. Various packing materials have been tried in the past in patients undergoing endoscopic sinus surgery, resulting in variable clinical outcome [5]. In spite of satisfactory hemostasis, conventional nasal packings are very painful and cause substantial mucosal damage in the postoperative period, which often lead to scarring/synechia, significantly contributing to the postoperative morbidity [2]. Instead, Rapid Rhino nasal packs can be applied in CRSWNP, aimed to overcome the postoperative complications and morbidities attributed to the Merocel [4, 8–10]. The Rapid Rhino pack (Arthrocare, Knaresborough, UK) is a balloon tamponade that swells up in the nasal cavity providing pressure over the mucosal blood vessels. Again, it promotes clotting through platelet aggregation due to the presence of carboxymethylcellulose (CMC)4 studded over the surface. Different clinical trials have been conducted in the past, claimed better clinical outcomes of Rapid Rhino over conventional packs in reducing postoperative hemorrhage in patients with anterior epistaxis [11–13]. Although rapid Rhino is more effective in reducing the postoperative pain and bleeding in contrast to the Merocel, its role in the healing of the nasal mucosa is still not well established [5]. Very few articles have been published in the past, confirming the role of Rapid Rhino nasal pack in relieving postoperative pain and bleeding after endoscopic sinus surgeries [10]. As demonstrated in the present study, the postoperative pain (at 6 h and at 48 h) in patients using Rapid Rhino nasal pack is significantly less as compared to the Merocel nasal pack g (p < 0.05) which is well supported by the different studies [12, 13]. Similar results have also been obtained with the use of Rapid Rhino, which revealed less patient discomfort and pain in the postoperative period [13, 14]. This reduction in the pain score with the Rapid Rhino nasal packing could be due to the lower intranasal pressure due to the uniform redistribution of the same and the slippery nature of the pack for easy manipulation. Again, the amount of blood loss and reactionary hemorrhage was significantly reduced in patients with Rapid Rhino nasal packing as compared to the Merocel packing (p < 0.05), which could have been the reason for its preference in anterior epistaxis [4], compared to the conventional nasal packs. This adequate hemostasis could be due to the slimy and non-stick external surface, which facilitates easy pack removal and the presence of CMC, augmenting the clotting by promoting the platelet aggregation. Ozcan et al. conducted a study including 51 patients who underwent endoscopic septoplasty, where he proposed that Rapid Rhino nasal pack were advantageous in easy pack removal, reducing the reactionary hemorrhage [13]. Healing of the nasal mucosa is a vital parameter not only contributes towards the success of the surgery but also for the postoperative morbidity in patients undergoing endoscopic sinus surgery. It is due to the injury of the nasal mucosa both during the insertion and removal of the nasal packs, causing a variable degree of crusting and fibrosis, in the postoperative period. In the present study, when we compared the mucosal healing between Rapid Rhino and Merocel nasal packs, a significant difference was detected at each follow-up period (p < 0.05). This could be explained by the inherent properties of the Rapid Rhino, which is a “wide surface low-pressure nasal pack” that causes minimal lateral pressure over the nasal mucosa. Hence the incidence of postoperative crusting/fibrosis is very minimal in patients with Rapid Rhino nasal pack [4]. Although Rapid Rhino is a better hemostatic nasal pack, we did not find any significant difference in the hospital stay between the two nasal packs (p = 0.24). Due to the slimy external surface, accidental expulsion of the Rapid Rhino could be a possible complication in the postoperative period [8, 12]. In the present study, one patient had unintentional removal of the Rapid Rhino pack in the immediate postoperative period, which required repacking. Also, the Rapid Rhino nasal packs had shown cost-effective compared to the chemical cauterization or bipolar cautery/absorbable nasal packs [15, 16]. In contrast to the conventional nasal packs, Balloon tamponade (Rapid Rhino) can be a valid alternative to be used after endoscopic sinus surgeries, significantly reducing the postoperative pain, bleeding, and mucosal healing. Larger sample size with long term follow-up may be required for a better understanding of the clinical outcomes.
Conclusion
Although balloon tamponade and Merocel nasal packs have been profusely used in the management of epistaxis, their role cannot be denied in patients after endoscopic sinus surgery. Besides reducing postoperative pain and bleeding, Balloon tamponade (Rapid Rhino) nasal pack is more effective in augmenting mucosal healing, decreasing crusting, and synechia compared to the Merocel nasal pack. However, Larger sample size with long term follow-up may be required for a better understanding of the clinical outcomes.
Acknowledgements
The current study has been approved by the ethical committee of the institute. There are no conflicts of interest among the authors. This research has not been supported by any financial agency or funding organization.
Compliance with Ethical Standards
Conflicts of interest
There are no conflicts of interest among the authors.
Ethical Standards
Institutional ethical committee approval has been taken for the research. Informed written consent was taken from each patient before the surgery. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Research involving the human participants.
Informed Consent
Written informed consent has been taken from each patient prior to the surgery and same has been informed to the institute reviewer board. No part of the body has been demonstrated in the case report without the permission of the concerned patient.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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