Outcome of Concurrent Septorhinoplasty and Functional Endoscopic Sinus Surgery (FESS) in Patients with Sinusitis and Nasal Deformity: A Retrospective Study and Review of Literature

Abstract

Patients with deformed external noses and deviated nasal septum also have lateral wall deformities compromising the osteomeatal complex leading on to sinusitis. These patients will need septorhinoplasty along with functional endoscopic sinus surgery (FESS) to facilitate proper drainage of sinuses. The two main risks of combined procedure are firstly the risk of infection if done in infected sinusitis and secondly, the fear of collapse of nasal bone and the frontal process of the maxilla if medial and lateral osteotomies are done after extensive ethmoidectomy for extensive sinus disease. Our objective was to study the outcomes of combined septorhinoplasty with functional endoscopic sinus surgery in patients having sinusitis along with nasal deformity. In this retrospective study we describe the outcomes of patients who have undergone combined FESS + Rhinoplasty. We controlled the sinus infection and avoided extensive polyposis for combined procedure. We found that nasal block, facial pain, anosmia, rhinorrhea improved in all the patients There was a complete resolution of symptoms in the group. Thus, in combined surgery, we could simultaneously get a good functional airway, solve the sinus complaints and improve the nasal aesthetics satisfactorily. The patients were subjected to SNOT scale in 2023 and average score of SNOT score was found as 11 at an average postop followup period of 14 Years post op. We found that combined Rhinoplasty and Functional Endoscopic Sinus Surgery for patients having nasal deformity with chronic Rhinosinusitis can be performed safely and effectively. Simultaneously harvested septal cartilage could be used judiciously for meticulous reconstruction. It, avoided the extra cost and patient’s time of two staged partial surgery.

Introduction

The nose which is the natural portal of air entry serves to humidify and warm it. These functions require adequate nasal passage in the absence of which obstruction develops [1, 2]. Nose is subject to birth trauma or accidental trauma which along with differential rate of growth will lead leads to deformed external shape and deviated nasal septum.

This alteration in the anatomical structure of the nose also cause changes in the lateral wall structures (Concha bullosa, Paradoxical middle turbinate, Inferior turbinate hypertrophy).Excessive deviation of septum can impede drainage of mucus from the sinuses leading to stasis and inflammation, edema and blockage of ostia when other environmental factors as pathogens or allergens are present potentiating a vicious cycle manifesting as sinusitis. [1, 2]

There is thus an inherent linkage between the anatomy of external nose and septum which impacts disease pathogenesis in the sinuses. Studies have discovered septal deviation is the primary factor involved in the pathogenesis of sinusitis. [3–7]. It was found that post septoplasty nasal mucociliary transport (NMTR) increase significantly both on deviated and non deviated sides. Elahi MM et al. have all showed an increased correlation between increasing grade of septal anomalies and anterior and posterior ethmoid disease. [6]

Previously, for patients with aesthetic nasal concerns who had concomitant nasal inflammatory diseases, the rhinoplasty surgeon was obliged to divide treatment into two stages. Management of the inflammatory abnormality was referred to the ear, nose, and throat specialist first, with the rhinoplasty planned after complete resolution of the disease [1, 8–15]. Because the first operation was often traumatic and painful, with heavy packing left in place for several days, the patient often refused the desired aesthetic procedure. The combined surgery was avoided for want of asepsis which is essential in facial plastic surgeries.

Shemen and Matarasso [10] first reported their experience with combined nasal and sinus procedures in 1991. In, 8 consecutive patients they reported no complications. In 1994 Toffel [11], documented his results with 698 patients undergoing endoscopic sinus surgery including 122 patients who had concurrent Rhinoplasty and sinus surgery.

The raison d’ eitre of doing Concurrent surgery is to clear the internal nasal passage by surgery of the septum, the lateral wall and correcting the deformities in the external wall such as collapse of roof of bony vault which may manifest as obstruction on the collapsed side. All these deformities create resistance to airflow and prevent adequate ventilation of sinuses. So, an ideal patient undergoing concurrent surgery is one with refractory sinusitis and external nasal deformity. [16, 17]

Various authors still differ on patient selection. Rizk et al. [9] prefer to avoid patients with severe debilitating symptoms with bilateral multifocal contiguous disease.Friedman et al. [18],recommended combined sinus surgery and Rhinoplasty in select patients excluding those patients who had Stage IV sinus disease as defined using the sinus CT scan staging system he had previously described. Still the literature shows a lot of debate on patient selection. The fears of complications due to preexisting infection necessitate stringent medical management of sinusitis prior to taking the patient for surgery. Most authors Rizk [9] Toeffel [11], Millman [12] stress on it.

The technique for FESS and Rhinoplasty is as chosen by the surgeons depending on the extent of disease. However most authors (Rizk [9], Marcus [13],Mazzola [14],Millman [12] recommend doing FESS first. The reason they give is that while doing surgery they can the assess the extent of sinus disease. They contend that if they find extensive polyposis or mucopurulent discharge or mycotic debris then the combined surgery be aborted in favor of staged procedure.

Benefits of Combined Surgery [1, 9, 10, 13–15]

1. Single manipulation of Septum:-Septum during septoplasty for crooked nose not only corrects the twisted nose but provided valuable graft material.

2. Reduced Hospital stay and Operative Time and Reduced Cost due to single stage combined surgery

3. Reduced healing/recovery time because only 1 stage.

4. Addresses overlapping symptomatology of functional airway problems which can be related to external nasal deformities and nasal valve deficiencies, as well as to the nasal septum and turbinates. [1, 17]

The Risks [1, 12–14]

The combined surgery poses combined risks as they involve two separate procedures each with their individual risk factors. The risk for major complications in FESS is between 2 and 21% (Terrell et al. [19], Millman [12]) These include further surgical intervention, blood transfusion, death of the patient, cerebrospinal fluid (CSF) leak, optic nerve injury, ocular motility deficits, injury to the nasolacrimal duct, permanent anosmia, and major intraoperative or perioperative hemorrhage. The incidence of major complications ranges from 0.5 to 9% [20–25]. Levine and May in 1993 [20] reported an incidence of 1.1% in 2583 patients.

The minor complications include Epistaxis, periorbital ecchymosis, synechiae and recurrent disease. Literature reviews shows that incidence of perioperative epistaxis within 48 h of surgery is 3%. The rate of synechiae post surgery is reported is reported in 4 to 8% of cases. Recurrent polyposis post surgery is also a complication seen in 18% of cases. [21–25]

For the Rhinoplasty surgery some of the complications overlap with that of sinus surgery, including epistaxis, infection, ecchymosis, septal perforation and rarely severe complications as Toxic shock syndrome.The overall complication rate reported in literature for Rhinoplasty varies between 5 to 15% (Mcgregor [1], Elshay [26], Osken [27]).

When, Rhinoplasty is done with FESS the risk of infection increases because of upper bony vault which has been opened by osteotomy comes in contact with the infected purulent sinuses. Millman [12] has reported a case series of 2 cases in which the patient developed moderate edema of the nasal and cheek area with septicemia and toxic symptoms. Overall the literature concludes on a positive note for the combined procedure.

Materials & Methods

This is a retrospective study carried out in patients with sinusitis and nasal deformity.This study was conducted by collecting records of all patients more than 18 years with atleast 3 month follow up who were operated in KLESH Prabhakar Kore Hospital Belgaum wherein cases done upto December 2012 with records and willingness for followup for an interview and examination were included. Study population included 13 cases,both males and females inclusive. This included all cases who had undergone concurrent Septorhinoplasty and functional endoscopic sinus surgery.A detailed history was collected from the records of the patients and patients preop A questionnaire was administered by telephonic interview which documented the subjective resolution of presenting complaints, satisfaction with surgery, and the self evaluation of aesthetic shape. We graded the four major symptoms in the nose viz. Nasal block, Facial pain, Rhinorrhea & Anosmia as shown in Table 1. A note of Pre-operative and Post operative clinical ENT examination was noted from the hospital records of the patient in all the patients. Analysis of pre-operative and post operative shape of nose was done using colour photographs in three views namely Frontal, Lateral and Basal where collected from the patient record. The preop and post op photos were then analysed for changes. Pre and post operative endoscopic findings were noted from the hospital records video recordings.The endoscopic findings were categorised with particular regard to status of the middle meatus space,the ostia patency,presence of mucosal edema/discharge, septal perforation, internal nasal valve area, synechiae. Surgical procedural details of rhinoplasty and FESS were noted from records.In addition a telephonic interview was done with all these patients in 2023 and history was taken using SNOT scale.

Table 1.

Scoring symptoms

	0	1	2	3	4
Symptom	Not a problem	Very mild problem	Moderate problem	Fairly bad problem	Severe problem
Characteristics		“Occasionally”	“Most of the time “	“Always”	“Always” and disturbs day to day activities

The surgical protocol followed by senior surgeon is as under:

Patient Preparation

Patient underwent maximal medical management with a 3 week course of antibiotics with mixed coverage along with enzymes and antihistamines and decongestants for sinusitis and only after control of the sinus symptoms the combined approach of Rhinoplasty + FESS was planned. Multiplanar 0.6 mm CT cuts were studied on the gantry prior to surgery to plan the FESS procedure meticulously. Extensive disease involving the frontal and the Agger was avoided. Literature review also agrees with the idea of avoiding patients for combined procedure in patients having extensive disease involving Frontal sinus (Rizk et al. [9], Mazzola et al. [14], Millman [12]). Preop photographs and diagnostic nasal endoscopy was done in all patients. The patients were also questioned about the severity of the symptoms.

Intraoperative Technique

FESS was done first followed by septoplasty unless the space on the convex side was less this was followed by Rhinoplasty with judicial harvest of conchal and temporalis fascia graft. Rhinoplasty was done by doing dorsum work followed by osteotomies and then the tip work. All absorbable suture used were PDS 5.0. 7 layer cast and sofradex pack was placed.

Postoperative Care and Follow-up

Antibiotics, antacids, analgesics, decongestants, enzymes and multivitamins were given.Pack was removed after 24 h and patient was advised to wash the nose with Inj Forcan. If crusting blocked the nose then endoscopic suction toilet was done. Plaster cast was removed after 10 days and patient then used the cast at night for protection.

Results

There were a total of 13 patients. Around 61% patients were between the age of 21–30 years and all 8 patients in these group presented with crooked noses. Around 31% patients are between the age of 31–40 years. 2 out of 4 patients in these group presented with crooked noses,1 patient presented with Broad Nose and the remaining 1 patient presented with Saddle Nose The group had almost an equal number of male and female patients viz 7 and 6 respectively. As we see in Table 2, Figs. 1 and 2: All patients experienced Nasal block (Grade 4 (12 of 13 patients; 92.3%)) preoperatively which improved to Grade 0 in 92.3% and Grade 1 in 1 patient. This patient had allergic symptoms. Facial pain was present in all patients ((8 of 13 patients (61.5%) patients; Grade 3, 3 of 13 patients; Grade 3). This improved to grade 0 in all patients.Facial pain overall severity was high in patients needing Rhinoplasty + FESS and all of them improved postoperatively to Grade 0.

Table 2.

Comparison of symptom scores between preop and postop symptom

Grades	NB_Pr	%	NB_ PO	%	FP_Pr	%	FP_PO	%	AN_Pr	%	AN_PO	%	Rh_Pr	%	Rh_PO	%
0	0	0	12	92.3	1	7.7	13	100	7	53.8	13	100	7	53.8	13	100
1	0	0	1	7.7	0		0	0	0	0	0	0	1	0	0	0
2	0	0	0	0	1	7.7	0	0	6	16.2	0	0	2	15.4	0	0
3	1	7.7	0	0	8	61.5	0	0	0	0	0	0	2	15.4	0	0
4	12	92.3	0	0	3	23.1	0		0	0	0	0	1	7.7	0	0

NB Nose block; FP Facial Pain; AN—Anosmia; Rh—Rhinorrhea

Pr—Pre op; PO—Post op

Fig. 1.

Preop symptom scores

Fig. 2.

Postop symptom score

Anosmia remained a minor complaint of Rhinoplasty + FESS patients seen in only 6 patient of 13 patients(46.2%) but after surgery it became normal in all patients. The minor nature of anosmia can be explained on the basis of absence of ethmoid polyposis in any of the patients. In Rhinoplasty + FESS group, rhinorrhea of Grade 3 was seen in 2 of 13 patients (16%) and Grade 4 in 1 case and it reverted back to normal in all cases post surgery.

The patients were then asked to evaluate the nasal shape aesthetics pre op and postop. As we see Table 3 all 13 patients (100%) had either deformed or horrible noses preoperatively. Post operatively Nose shape in all the patients improved to Beautiful or Normal. These patients also had bad septal deviations grade 2 in 9 of 13 patients. Open rhinoplasty with dorsal augmentation, tip and ala plasty with lateral and medial osteotomies was done as per the requirements of the aesthetics.Operation records showed that unilateral FESS was done in 3 cases and bilateral FESS was done in 10 cases. Summary of which is listed in Table 4. The FESS procedure significantly opened up the middle meatal space in all the patients. The Grades 0,1,2 corresponded to no space or recurrence of polyps and purulent nasal discharge, less space or early polypsis and minimal edema, adequate space and no recurrence and no evidence of thick purulent discharge The endoscopic findings document the improvement of major sinus symptoms in these patients specially facial pain and rhinorrhea (Table 5). The patients were subjected to SNOT scale in 2023 via a telephonic interview and an average SNOT score was found as 11 at an average postop followup period of 14 Years post op. More importantly most patients did not report being troubled by CRS symptoms. None of the patients did not go for a repeat surgical procedure for their preop symptoms.

Table 3.

Comparision of External Nose shape Between Preop And Postop In Rhinoplasty + FESS Patients

Nose shape	FR_PREOP	%	FR_PO	%
Beautiful	0	0	11	84.61
Normal	0	0	2	15.38
Deformed	8	61.53	0	0
Horrible	5	38.46	0	0
Catastrophic	0	0	0	0

Table 4.

Summary of FESS procedures done

Procedures	No of sides
MT only	1
MT + MS only	2
MT + MS + AE only	2
MT + MS + AE + FR only	6
MT + MS + AE + FR + PE only	2
MT + MS + AE + FR + PE + SPH only	13
MS only	1
Uncinectomy	26

Legends MT—MT partial resection/Conchoplasty; MS—Maxillary antrostomy; AE; PE—Anterior;Posterior Ethmoidectomy; FR—Frontal recess/ostia opening; Sph—Sphenoidomy

Table 5.

Comparision of Middle Meatal Space Findings—Postoperatively

Grading Improvement In Middle Meatal space	Fess + Rhinoplasty
0	No of patients	%
1	1	7.69
2	12	92.69

Overall the combined procedure was safe with no report of dangerous infections or graft necrosis due to aseptic field. As shown in Table 6. In Rhinoplasty + FESS group Septal perforation, remained the most common complication in affecting 2 of 13 patients i.e. in 15% of cases. These perforations both patients were < 2 cms Both the patients had an impacted Deviated nasal septum requiring submucosal resection.

Table 6.

Post Operative complications in RHINOPLASTY + FESS patients

Post Op complication in Rhinoplasty + FESS Patients	No. Of patients	%
Synechiae	1	7.69
Ostia closure	0	0
Revision fess	0	0
Septal perforation	2	15.38
Saddling	0	0
Supratip beak	0	0
Shifting of graft	0	0
Button holing	0	0
Infection	0	0

Discussion

In our series the mean age remained 27 years. Around 61% patients were in the age group between 21 and 30 years and all these presented with crooked noses. Mean Followup Period in FESS + Rhinoplasty Group was around 3.5 year. The minimum followup period in all groups was 3 months.

In all patients who had undergone Rhinoplasty with FESS nose block improved from Grade 3 or 4 to Grade 0 in 92% cases (Table 2). The study by Zhu et al. [16] using computational fluid dynamics found that shape of the anterior nasal roof was found to be collapsed on one side of the nasal airways in all the deviated noses. High wall shear stress region was found around the collapsed anterior nasal roof. The nasal resistances in cavities with deviated noses were considerably larger than healthy nasal cavity. They concluded that the deviation of an external nose is associated with the collapse of anterior nasal roof. The crooked external nose induced a larger nasal resistance compared to the undeviated case. [16]

Another study by Veit J [17] found that Functional rhinoplasty (SRP) is a surgical procedure for improvement of symptomatic deformity of the inner and outer nose. Due to inadequate preoperative analysis and consequently insufficient surgical indication, septoplasty (SPL) alone may be performed. A frequent cause for revision rhinoplasty (rSRP) in our institution was found to be due to a deviated bony pyramid in compound with a contralateral high deviation of the perpendicular plate, ipsilateral reluxation of the cartilaginous septum and a resulting nasal valve stenosis. [17]

In our study, as we see in Table 2 in the patients needing Rhinoplasty + FESS the severity of Facial pain overall was higher (11 of 13 patients had Grade 3, Grade 4 facial pain preoperatively). The presence of facial pain was a deciding factor in considering these patients in the latter group for FESS also in addition to Rhinoplasty. The purpose of doing the combined surgery was the presence of higher grade of Facial pain.

In a study by Rizk et al. [9] on Concurrent Rhinoplasty and FESS, they found that preoperatively 65% patients experienced facial pain which improved to the satisfaction of patients in all patients post combined surgery. In our Rhinoplasty and FESS group 92% had severe facial pain preoperatively and all improved postoperatively.When we analyzed the patients with Grade 4 facial pain preoperatively (as in Table 2) we found that 100% patients in FESS + RHINOPLASTY group improved from Grade 4 to Grade 0 postoperatively. Anosmia was seen in 46% of Rhinoplasty + FESS patients which reverted to normal in all patients post operatively.

Anosmia is seen in.

• i.Severe cases of sinusitis Rizk et al.. [9]
• ii.Due to middle turbinate hypertrophy blocking the olfactory cleft area
• iii.Severe obstruction of the internal nasal valve area due to collapse of bony vault in crooked noses
• iv.Severe nasal obstruction secondary to polyposis

The internal nasal valve and the collapse of the upper bony vault in the crooked noses cannot be corrected by FESS alone, Sinusitis, Sino nasal polyposis and Middle turbinate anomalies cannot be dealt with by a rhinoplasty alone. On the other hand, while doing combined surgery we can deal and correct satisfactorily all the above 5 factors.

Purulent Rhinorrhea was considered a part of classical triad of sinusitis consisting of facial pain, nasal obstruction. It is still considered one of the major criteria for diagnosisng sinusitis. It was present preoperatively in 38% cases in Rhinoplasty + FESS group and there was a total resolution of their rhinorrhea post operatively. A review revealed that rhinorrhea as a symptom was seen in 50% patients undergoing concurrent surgery in study by Rizk [9] and in 46% cases in study by Macgregor [1]. Further there was a complete resolution in the concurrent group post surgery. Our results are in consonance with the above reviews The improved aesthetic outcome added to the improved satisfaction of the patients in the Rhinoplasty and FESS. The improved nasal aesthetics can be attributed to the more conservative techniques employed to correct the deformities.

Review of literature revealed that Rizk et al. [9] as given in Table 7; classified patients coming for aesthetic rhinoplasty with sinus disease into 3 categories viz Mild, Moderate, and Severe on the basis of severity of sinusitis. In severe disease Patients had more debilitating symptoms (anosmia, frequent headaches) and Stage III disease as per the CT scan disease (bilateral, multifocal, contiguous pan polypoid disease) usually involving the frontal or sphenoid sinus. The severe disease is considered a relative contraindication by the author in doing combined surgery.In our series none of the patient had severe Grade III disease. Some recent case control studies have revealed some conflicting views on outome. [29–31]

Table 7.

Selection criteria of patients while Doing Concurrent Rhinoplasty + FESS as per Rizk et al [9]

Category 1:- patients coming for fess who also need rhinoplasty
If the patient has symptoms of nasal block, facial pain, with reduced middle meatal space with/without sinus tenderness without external nasal deformity and internal nasal valve area involvement, he will definitely need FESS for control of sinusitis
If, this patient in addition has external nasal deformity and internal nasal valve area involvement then he is motivated to undergo Rhinoplasty along with FESS
Category 2:- patients coming for rhinoplasty who also need fess
In a patient with external nasal deformity coming primarily for aesthetic rhinoplasty, if he has lateral nasal wall anomalies ( Concha bullosa, Paradoxical Middle turbinate, Hypertrophied Inferior turbinate) obstructing the nasal space
Category 3:- Patients Needing Only Rhinoplasty
In a patient with external nasal deformity coming primarily for aesthetic rhinoplasty, if he has no features of sinusitis or lateral nasal wall anomalies and no significant septal deviation, then he will need only Rhinoplasty

As seen in Table 6 the most common long term complication encountered was septal perforation, which was seen in 2 out of 13 patients (15%). The literature review shows that surgery remains the most important cause of septal perforation. According to Dosen [28] the most frequent cause of septal perforation was SMR with an incidence of 39.2% but it is almost halved to 14.7% in cases in whom septoplasty/septorhinopasty was done. In our series the rate was close to that of septoplasty.A deeper analysis of the data reveals that the patients with septal perforation had the underlying factors.

• A.Impacted DNS—Seen in both the cases
• B.Disruption of blood supply: In both these cases a large septal perforation of > 5 cm was there probably due to fact that the deep bony part is removed the circulation to the septum coming from the Sphenopalatine artery was probably jeopardized. So, postoperatively the patient had a lot of crusting which became infected and sloughed out. This patient experienced severe post operative sloughing.

There are certain complications specific to Combined surgery (Friedman [18], Macgregor [1]).

• Fear of collapse of Nasal bone after Ethmoidectomy has been done

• Fear of instability in the frontal process of the maxilla that may result from removal of Agger nasi and frontal recess cells when the procedure is performed in combination with medial and lateral osteotomies. In our series, we never encountered these problems despite ethmoidectomy being done in all but 2 cases along with frontal sinusotomy and Agger nasi clearance in 10 out of 13 (77%) cases in the concurrent series.

Though reviews by Millman et al. [12] report few cases of Septal abscess and Toxic shock syndrome in their series we did not encounter any serious complications It is apparent that the combination surgery is safe in the right patient. In our series none of the patients had Grade III disease and all the patients were given maximal course of antibiotics for atleast 3 weeks prior to surgery till the rhinorrhea and facial pain subsided. We also did FESS before rhinoplasty. We feel that this order of doing surgeries and meticulous pre operative preparation is key to prevent post operative infection and their dangerous sequelae.

A recent meta analysis done by Bitner et al. [32] screened 55 articles upto 2019 and included 190 patients who underwent combined FESS and rhinoplasty whereas 45 patients underwent FESS and 170 underwent rhinoplasty to analyse data for postoperative complications, recurrence of CRS symptoms, revision rates, and patient satisfaction, respectively. Major complications were observed in 11 (5.8%) total combined cases, 0 (0%) FESS cases, and 6 (3.5%) rhinoplasty cases with no statistical difference between combined cases and rhinoplasties (OR 1.37, 95% CI 0.45–4.16, p ¼ 0.58). Recurrence of CRS symptoms was noted in 35.6% combined cases and 28.9% FESS cases (OR 1.42, 95% CI 0.55–3.64, p ¼ 0.47). There was no observed difference in revision rates between combined and isolated rhinoplasties (OR 1.00, 95% CI 0.43–2.32, p ¼ 1). Lastly, 91.6% of patients were satisfied with results of combined cases compared to 87.4% of patients in standalone cases (OR 1.57, 95% CI 0.61–4.03, p ¼ 0.35).

Literature reviews also informs us about the increased duration of postoperative swelling and edema in case of combined surgery as compared to when only rhinoplasty was done. In our series, all the patients in the combined group were discharged the next day after the operating surgeon was convinced that the facial edema was not significant.

There are certain complications specific to Rhinoplasty as in Collapse of nasal bone, Shifting of Dorsal Graft. The collapse of nasal bone was not seen in any case in our series.

Conclusion

In this retrospective case series we studied the outcomes in patients who had undergone FESS + Rhinoplasty. It, avoided the extra cost and patient’s time of two staged partial surgeries. We found that nasal block, facial pain, anosmia, rhinorrhea improved in all the patients with a complete subsidence in the combined group.The resolution of these complaints correlated with correction of external deformities and internal septal and lateral wall anomalies in the combined group. Further the simultaneously harvested septal cartilage could be used judiciously for meticulous reconstruction.

We suggest that a patient to be taken up for combined surgery must be evaluated by CT scan and diagnostic nasal endoscopy to rule out extensive pansinusitis and polyposis. Also they must be given maximal medical therapy to control active sinus disease. We also feel that doing FESS first and rhinoplasty later can alert us to any severe disease in the sinuses which can jeopardise the results of Rhinoplasy.

Overall, we feel that the combined surgery offers a safe, effective and complete treatment strategy to solve the triad of problems of sinusitis, functional airway and nasal aesthetics. In particular patients with Crooked noses with sinus complaints must be considered for the combined procedure.

Author Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Dr. Mohit Sinha & Dr. R.N. Patil. First draft of the manuscript was written by Dr. Mohit Sinha and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Funding

None.

Declarations

Conflict of interest

None.

Human and Animal Rights

This study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. As per ICMR guidelines study involved less than minimal risk to the participants and all patient particulars were duly anonymized.

Informed Consent

Informed consent was not required due to retrospective nature of study.