Abstract
Endoscopic septoplasty has advantage of magnified image and access to posterior part of the septum. Synechiae formation is a common complication of this procedure. The incidence of adhesions rises particularly in cases of submucosal flap tears which is sometimes unavoidable during spurectomy. Various procedures like septal splints, nasal packings have been tried to reduce the incidence of adhesions. Recently mitomycin-C is being tried to decrease post operative adhesions after Functional Endoscopic Sinus Surgery, endoscopic Dacrocystorhinostomy, with varying degree of success. Mitomycin-C has got anti fibroblastic activity, which inhibits the fibroblasts without hampering epithelization. Eighty (80) Patients undergoing septoplasty and spurectomy were observed for any submucosal flap tear, and those developing flap tear were included in the study. The patients were divided into 2 groups of 40 each. In group-1 topical mitomycin (0.4 mg/ml) was applied at the raw area for 5 min, similarly normal saline was applied in group-2 (control).The aim of study was to evaluate the role of mitomycin-C in preventing post operative adhesions in Endoscopic septoplasty. Adhesion rate was calculated at 1 month, and compared using Chi square test. P value < 0.05 was considered significant. The adhesion rate at 1 month was 17.5% in group-1 and 45% in group-2 (P = 0.008). Incidence of adhesion decreased significantly in mitomycin-C treated group. Mitomycin-C can routinely be used in septoplasty to prevent post op adhesions, particularly in cases of submucosal flap tears/concurrent turbinate reduction procedures.
Keywords: Mitomycin-C, Endoscopic-septoplasty, Post-operative synechiae
Introduction
There is a high prevalence of deviated nasal septum in human population. Its prevalence varies in different races and ethnic groups. According to estimates, 80% of all nasal septums are off the center, not all being symptomatic [1]. Prevalence varies in different age groups there are studies reporting varying degrees of nasal septal deviation in newborns [2–5].
Spurs frequently occur at the junction of the quadrangular cartilage and maxillary crest or vomer. The perichondrium of the quadrangular cartilage and the periosteum of the maxillary crest are not contiguous, so the dissection in these areas can be difficult, and flap tears are sometimes unavoidable [6].
Development of intranasal adhesion has been frequent post-operative complication of intra nasal surgeries, incidence varying from 10% up to 36% [7, 8]. The adhesions occur between septum and structures on the lateral wall, mostly the inferior turbinate. Intra-operative mucoperichondrial/mucoperiosteal flap tears, concurrent turbinate resection, poor post-operative care leading to excessive crusting are high risk for synechia formation.
Septal clips were used to prevent adhesions, with varying degree of success, but they increased the comorbidities such as pain and discomfort in the post-surgical period [9].
Mitomycin-C has antimicrobial as well as anti-neoplastic activity. It also acts as an anti-proliferative agent that can inhibit fibroblast activity and suppress fibrosis and scar formation, without hampering mucosal epithelial growth [10, 11]. Topical mitomycin C has been tried in FESS and endoscopic DCR (dacryocystorhinostomy) with varying degree of success. This is perhaps the first study regarding the role of Mitomycin C in preventing post-operative adhesions in patients who developed intra- operative mucoperichondrial/mucoperiosteal flap tear while undergoing septoplasty.
Materials and Methods
This prospective study was conducted in a tertiary care hospital after approval from institutional ethical committee. The patients attending the otorhinolaryngology clinics in our hospital with complaints of nasal obstruction, headache, post nasal drip and on examination had deviated nasal septum were admitted for evaluation and subsequent septoplasty. A detailed history was taken of all selected patients, using a specially designed proforma followed by thorough examination including diagnostic nasal endoscopy and Non-contrast Computed Tomography (NCCT) of Para nasal sinuses. After complete evaluation patients were planned for endoscope assisted septoplasty under local anaesthesia and written informed consent was taken for the same.
After adequate pre-medication bilateral nasal cavities were packed with neuropatties soaked in xylocaine 4% with adrenaline (1:100,000). The neuropatties were removed after 10 min and septal submucosal local infiltration with xylocaine 2% with adrenaline (1:100,000) was done, posterior to anterior, under endoscopic guidance (0° 4 mm rigid endoscope). The initial incision was placed just caudal to the deformity, muco-perichondrial and muco-periosteal flaps were then elevated using suction elevator. Septal cartilage was incised a few millimetres posterior to the mucosal incision, and contralateral muco-perichondrial and/or muco-periosteal flaps were then raised. Special care was taken while raising the flaps at spur and at bony cartilaginous junctions. Deviated septal cartilage was excised using small Luc’s or Blakesley nasal forceps. Any deviated portion of the vomer and perpendicular plate of the ethmoid was removed if necessary. Finally, the septal flap was repositioned and incision line was sutured with 3-0 absorbable sutures.
In this study, 80 such cases of flap tears were included. Those cases who did not develop any flap tear, or those who underwent concurrent endoscopic sinus surgery or dacryocystorhinostomy were excluded from the study.
The patients were divided in 2 groups, each comprising of 40 patients. In group 1 (Test group), a cotton pledget soaked in 1 mL Mitomycin C (0.4 mg/mL) was applied at the site of flap tear. The cotton pledget was removed after 5 min. The area was then suction-irrigated thoroughly with 30 mL of distilled water. In group 2 (control group), a similar cotton pledget soaked in 1 mL normal saline was applied at the site of flap tear for 5 min. The area was then suction-irrigated. The nasal cavities were packed with merocel. Antibiotics and other supportive medications were given post- operatively. Nasal packs were removed after 24-48 h, and the patients were discharged.
Patients were followed at 2 weeks, 1 month and 3 months. Enquiries regarding symptoms and nasal endoscopy were done at each visit with special emphasis on the site of flap tear or formation of adhesion. Adhesion rate was calculated at 1 month [Adhesion rate = (Number of nasal cavities with adhesions/Number of nasal cavities which developed flap tears) × 100].
Statistical methods used Chi square test was used to compare the adhesion rates between the control group and test group. P value < 0.05 was considered as significant.
Observations
In this study there were 80 cases, divided into 2 groups, each consisting of 40 patients. In group-1 Mitomycin-C was applied and in group-2 normal saline was applied at the site of flap tear. There were 57 males and 23 females, with male to female ratio of 2.5:1. Most patients who underwent endoscopic- septoplasty were from urban background (Rural 31, Urban 49). The minimum age was 18 years and the maximum age was 54 years, with mean age of 26.33 ± 6.8 years (Table 1).
Table 1.
Sex and Age wise distribution
| Age group | Total | Males | Females | Mean Age | Male:Female ratio |
|---|---|---|---|---|---|
| 11–20 years | 13 | 9 | 4 | 26.33 ± 6.8 years | 2.5:1 |
| 21–30 years | 41 | 29 | 12 | ||
| 31–40 years | 16 | 11 | 5 | ||
| 41–50 years | 7 | 5 | 2 | ||
| 51–60 years | 3 | 3 | 0 | ||
| Total | 80 | 57 | 23 |
The most common presenting complaint was nasal obstruction in 63 patients, headache in 28 patients, post nasal drip (PND) in 15 patients and bleeding from nose in 8 patients (Fig. 1).
Fig. 1.
Venn diagram depicting symptomatology of the patients
Endoscopic Examination Findings
All the patients had deviated nasal septum (DNS) with septal spur. There was right sided DNS in 31 patients, while 35 patients had left sided deviation, and S-shaped deviation was seen in 14 patients. Inferior turbinate hypertrophy was seen in 61 (76.25%) patients, of which 26 patients had right inferior turbinate hypertrophy, 25 patients had left inferior turbinate hypertrophy, while 10 patients had bilateral inferior turbinates hypertrophy (Table 2).
Table 2.
Endoscopic examination findings
| Findings | No. | Total | |
|---|---|---|---|
| DNS | Right | 31 | 80 |
| Left | 35 | ||
| S-shaped | 14 | ||
| Spur | Right | 43 | 80 |
| Left | 37 | ||
| Inferior turbinate hypertrophy | Right | 26 | 61 (76.25%) |
| Left | 25 | ||
| Bilateral | 10 | ||
Results
Patients were followed at 2 weeks, 1 month and 3 months. They were enquired about the symptoms and endoscopic nasal examination was done to look for any synechiae formation at the site where flap got teared during surgery and the findings were noted for both the groups (Table 3).
Table 3.
Endoscopic examination findings at follow-up
| Post op follow up | Synechiae | |
|---|---|---|
| Group-1 (mitomycin C 0.4 mg/mL) | Group-2 (control) | |
| 2 weeks | 5 (12.5%) | 13 (32.5%) |
| P value = 0.032 | ||
| 1 month | 7 (17.5%) | 18 (45%) |
| P value = 0.008 | ||
| 3 months | 10 (25%) | 19 (47.5%) |
| P value = 0.036 | ||
All the patients were relieved of nasal obstruction. Most of the patients with headache (21 out of 28) had improved by the end of 2 weeks, whereas the remaining 5 patients were relieved by 1 month, while 2 patients had persistent headache even at 3 months. All the patients of PND and epistaxis showed remarkable improvement by 1 month.
There was decrease in incidence of synechia formation in group-1 as compared to control group-2. In group-1 only 5 of 40 (12.5%) patients developed synechia at 2 weeks whereas, it was 13 of 40 (32.5%) patients in group-2. This difference was statistically significant (P = 0.032). There was increase in number of patients developing synechia at 1 month and 3 months in both the groups. At 1 month the number of patients with synechia were 7 (17.5%) in group-1 and 18 (45%) in group-2, which was also statistically significant (P = 0.008). At 3 months this number increased to 10 (25%) in group-1 and 19(47.5%) in group-2, which was again statistically significant (P = 0.036). Adhesion rate at 1 month was 17.5% in group-1 and 45% in group-2, the difference being statistically significant (P = 0.008).
Discussion
The procedures for correction of deviated nasal septum has evolved over time. Various modifications have been made in the earlier methods of radical septal resection which has evolved into more conservative methods like septoplasty. Endoscope assisted septoplasty has advantage of good exposure of posterior deviations and magnified image, as compared to conventional septoplasty.
Since the early days of intra nasal surgeries, adhesion formation has been an important post-operative complication, which varies from 10% to 36% [7, 8]. There are studies which shows the incidence of adhesion formation after septoplasty to be ranging from 8.3% to 25% [12–14].
Intra-nasal adhesions are formed when two mucosal surfaces are in contact and at least one of which has raw area like in post- surgery or trauma. The risk of adhesion formation increases in cases of mucoperichondrial/mucoperiosteal flap tears, which is common while performing spurectomy. The incidence further rises when both the opposing mucosal surfaces have raw areas, as in cases of combined procedures like septoplasty with endoscopic sinus surgery, and septoplasty with turbinectomy. Some authors have reported increased incidence of synechiae, up to 36% when septoplasty was combined with turbinate resection procedures [8].
Use of intra-nasal splints started in 1980′s in an attempt to decrease synechia formation and to keep septum in position. The incidence of synechia had decreased by the use of intra-nasal splints, but did not prove to be statistically significant. This was evident by the survey carried out by Pringel [15] in which the incidence of synechia in non-splinted group was 5.2% in comparision to 3.9% in splinted group, which was not statistically significant.
Topical application of Mitomycin-C has recently been used in endoscopic sinus surgery and endoscopic endonasal dacryocystorhinostomy to decrease the incidence of synechia formation. Recent studies on mitomycin-C in endoscopic sinus surgeries have shown beneficial effect in preventing synechiae without any side effects/complications [16–20]. It has also been tried in endoscopic dacryocystorhinostomy recently [21–23] and proved to be beneficial in terms of reducing synechia formation as well as preventing ostial stenosis [21–24]. To the best of our knowledge, this is perhaps the first study regarding the role of Mitomycin C in synechiae prevention in post- septoplasty patients.
We carried out study on those patients who were undergoing septoplasty and developed mucoperichondrial/mucoperiosteal flap tears while performing spurectomy. Our study included 80 patients of septoplasty with flap tears, which comprised of 71.25% males, with male to female ratio of 2.5:1. The maximum numbers of patients were in second and third decade, with mean age of 26.33 ± 6.8 years. The most common presenting complaint was nasal obstruction (78.75%), headache was present in 35% whereas post nasal drip in 18.75% and nasal bleed in 10%.
The adhesion rate at 1 month post- surgery follow-up in group-1 (Mitomycin C group) was 17.5%, and in group-2 (control) was 45% (P = 0.008), however at 3 months it was 25% in group 1 and 47.5% in group 2 (P = 0.036).
The adhesion rate in our study is higher than previous other studies as we had included only those cases which developed intra- operative flap tears, which itself is a high risk for synechia formation.
The incidence of synechia has decreased considerably in mitomycin-C (0.4 mg/mL) treated group, the difference being statistically significant (P = 0.008) at 1 month and (P = 0.036) at 3 months.
Conclusion
There is increased incidence of synechia in septoplasty in cases of mucoperiosteal/mucoperichondrial flap tears. Mitomycin-C appears to decrease the incidence of synechia in early post op period. It can routinely be used in septoplasty, particularly in cases which are at high risk of synechia formation, such as flap tears or when the spurectomy is done.
The limitation of this study is its small sample size because of inclusion of only the cases of flap tears. Studies with larger sample size and longer follow up are required to further confirm our findings.
Compliance with Ethical standards
Conflict of interest
All authors declare that they have no conflict of interest.
References
- 1.American Academy of Otolaryngology (2009) Fact Sheet: Deviated Septum. 04 Feb 2009
- 2.Alpini D, Corti A, Brusa E, et al. Septal deviation in newborn infants. Int J Pediatr Otorhinolaryngol. 1986;11:103–107. doi: 10.1016/S0165-5876(86)80004-0. [DOI] [PubMed] [Google Scholar]
- 3.Hamid OA. Deviated Nasal Septum in Saudi Newborns. Ann Saud Med. 1990;10(3):293–295. doi: 10.5144/0256-4947.1990.293. [DOI] [Google Scholar]
- 4.Cottle MH, Fischer GG, Loring RM, et al (1956) Early nasal injuries. Presented at the Meeting of the American Medical Association. (Cited in: Jazbi B (1977) Subluxation of the nasal septum in the newborn: etiology, diagnosis, treatment. Otolaryngol Clin North Am 10:125–36) [PubMed]
- 5.Abhinandan Bhattacharjee S, Uddin PP. Deviated nasal septum in the newborn—A 1-year study.Indian Journal of. Otolaryngol Head Neck Surg. 2005;57(4):304–308. doi: 10.1007/BF02907694. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Goyal P, Hwang PH (2012) Rhinology: diseases of the nose, sinuses, and skull base, Ch 34. In: Surgery of the septum and turbinates Thieme publications, pp 444–456
- 7.Shone GR, Clegg RT. Nasal adhesions. J Laryngol Otol. 1987;101:555–557. doi: 10.1017/S0022215100102233. [DOI] [PubMed] [Google Scholar]
- 8.White A, Murray JA. Intranasal adhesions formation following surgery for chronic nasal obstruction. Clin Otholaryngol. 1988;13:139–143. doi: 10.1111/j.1365-2273.1988.tb00754.x. [DOI] [PubMed] [Google Scholar]
- 9.Junior RGC, et al. Frequency of nasal synechia after septoplasty with turbinectomy with or without the use of nasal splints. Int Arch Otorhinolaryngol. 2008;12:124–127. [Google Scholar]
- 10.Rahbar R, Shapshay SM, Healy GB. Mitomycin: effects on laryngeal and tracheal stenosis, benefits and complications. Ann Oto Rhino Laryngo. 2001;110:1–6. doi: 10.1177/000348940111000101. [DOI] [PubMed] [Google Scholar]
- 11.Lee DA. Antifibrosis agent in glaucoma surgery. Invest Ophthalmol Vis Sci. 1994;35:3789–3791. [PubMed] [Google Scholar]
- 12.Rohail A, Khan AA, Shafi A, Zia R, Akram S. Frequency of intranasal adhesion in septoplasty without putting nasal splints. PJMHS. 2015;9(2):498. [Google Scholar]
- 13.Jain L, Jain M, Chouhan AN, Harshwardhan R. Conventional septoplasty verses endoscopic septoplasty: a comparative study. Peoples J Sci Re. 2011;4:24–28. [Google Scholar]
- 14.Bothra R, Mathur NN. Comparative evaluation of conventional versus endoscopic septoplasty for limited septal deviation and spur. J Laryngol Otol. 2009;123:737–741. doi: 10.1017/S0022215108004192. [DOI] [PubMed] [Google Scholar]
- 15.Pringle MB. The use of intra-nasal splints: a consultant survey. UK Clin Otolaryngol Allied Sci. 1992;17(6):535–539. doi: 10.1111/j.1365-2273.1992.tb01714.x. [DOI] [PubMed] [Google Scholar]
- 16.Harugop AS, Mudhol R, Nargund A, Hugar S, Kapoor A, Shetty R. Efficacy of Mitomycin-C for prevention of adhesion formation after functional endoscopic sinus surgery in cases of chronic rhinosinusitis: a prospective cross-sectional study. Clin Rhinol An Int J. 2014;7(3):100–104. doi: 10.5005/jp-journals-10013-1207. [DOI] [Google Scholar]
- 17.Wellington YY, Luuis C. The use of mitomycin-C to reduce synechia in middle meatus in sinus surgery: preliminary results. Braz J Otorhinolaryngol. 2012;78(5):44–50. doi: 10.5935/1808-8694.20120007. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Vaidyanathan V, Balasubramanian D, Suria Gopalakrishnan S, Saxena SK, Shanmugasundaram N. Topical Mitomycin C in functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012;269:1791–1794. doi: 10.1007/s00405-011-1870-x. [DOI] [PubMed] [Google Scholar]
- 19.Tilakraj S, Himani L, Natesh V. Role of Mitomycin-C in prevention of post operative adhesions after endoscopic sinus surgery—a prospective study. Indian J Otolaryngol Head Neck Surg. 2011;63(3):249–254. doi: 10.1007/s12070-011-0145-6. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Chung JH, Cosenza MJ, Rahbar R, et al. Mitomycin C for the prevention of adhesion formation after endoscopic sinus surgery: a randomized, controlled study. Otolaryngol Head Neck Surg. 2002;126:468–474. doi: 10.1067/mhn.2002.124705. [DOI] [PubMed] [Google Scholar]
- 21.Gupta V, Singh I, Dwivedi G, Goyal S, Kumar M, Sood A, et al. A comparative study in the use of topical mitomycin-C versus nasolacrimal stent in endoscopic dacryocystorhinostomy for chronic dacryocystitis. Int J Otorhinolaryngol Head Neck Surg. 2018;4:176–184. doi: 10.18203/issn.2454-5929.ijohns20175621. [DOI] [Google Scholar]
- 22.Farooq MU, Ansari MA, Khyani IAM. Role of mitomycin-c in endoscopic management of nasolacrimal duct obstruction. J Dow Univ Health Sci Karachi. 2013;7(2):63–67. [Google Scholar]
- 23.Harugop AS, Rekha BK, Mudhol RS, Zingade ND, Hugar SM, Das AT, Maheswaran M. Randomized placebo controlled trial of Mitomycin-C in surgical outcome of primary endoscopic dacryocystorhinostomy. Al Ameen J Med Sci. 2013;6(3):231–236. [Google Scholar]
- 24.Jain NK, Vashistha S, Kaushik S. Comparative study of endonasal endoscopic dacryorhinostomy with or without intraoperative Mitomycin C. Clin Rhinol: Int J. 2013;6(2):77–79. doi: 10.5005/jp-journals-10013-1157. [DOI] [Google Scholar]