Abstract
Rationale and objectives
Adhesions are the most common complication after nasal surgery and revision. 5-Fluorouracil (5-FU) reduces various adhesions and epithelial growth related complications. The aim of this study was to evaluate the effects of 5-flurouracil application in the nasal cavity after a multi-procedure nasal surgery in term of complications frequency.
Materials and methodology
Institutional ethical approval was granted and a double-blinded prospective clinical trial was conducted to study the effect of 5-fu on post-operative complications. At the end of a combined endoscopic inferior turbinoplasty with one or more other nasal surgeries, 5-flurouracil-soaked cottonoid with 1 mL of 5-flurouracil (5 mg/mL) was applied in one side of nasal cavity and saline-soaked cottonoid was applied contralaterally and left for 5 min. Patients were assessed over 2 months postoperatively by a blinded observer in terms of adhesions, crustation, discharge, pain, discharge, loss of smell and other complications and nasal symptoms.
Results
On the 1st follow up week postoperatively, adhesions were observed in (24 patients) 35%, bilateral in (6 patients) 9% and unilateral in (18 patients) 26%. Unilateral Adhesions were statistically significantly higher in control sides than those in 5-FU sides (22% vs 4% respectively) (p = 0.025). Crustation, continued to statistically significantly diminish over time (p = 0.035). On the 8th follow up week, adhesions reduction was still statistical significant at the 5-FU treated side (p = 0.01).
Conclusion
5-FU is safe and effective in preventing adhesions formation when applied during combined endoscopic inferior turbinoplasty procedure with other nasal procedure surgery.
1
Introduction
Nasal surgeries include variety of procedures for nasal septum, middle and inferior turbinates, sinus ostia, nasal cavity masses, lacrimal sac and nasal cavity blood vessels .
It is common to undergo several nasal procedures in one nasal surgery. This will reduce cost and work absence time for the patient, but may increase risk of some complications. The complications may involve bleeding, infection, pain, adhesion, granulation tissue formation or septal perforation . The aim of nasal surgeries is to remove obstruction and improve nasal air flow, cure disease and facilitate sinus drainage hence improving nasal breathing while causing as minimal tissue damage as possible . Tissue damage may be in form of a direct tissue injury intraoperatively or indirectly by means of abnormal healing such as in adhesion formation postoperatively .
Adhesions are one of the most common complications after endoscopic nasal surgery and cause of functional endoscopic sinus surgery (FESS) revision . 5-Fluorouracil (5-FU) is used by many medical specialties to reduce various adhesions and epithelial growth related complications on so many levels; for instance, it is used in the field of ophthalmology to increase the survival of trabeculectomy, where it was shown to be safe and is also used in dermatology to treat actinic keratosis and psoriasis .
Both antimetabolitic agents, 5-FU and mitomycin C, have been shown to inhibit human Tenon’s capsule fibroblast proliferation . It is a pyrimidine analogue known to inhibit fibroblast proliferation by inhibition of thymidylate synthase necessary for DNA synthesis .
Literature shows efficient use of 5-FU as an antimetabolitic agent in endoscopic dacryocystorhinostomy (DCR) surgery and to decrease adhesions and stenosis . Many studies reported reduced nasal cavity adhesions using antimetabolitic agents postoperatively, such as mitomycin C for preventing intranasal adhesion post endoscopic nasal surgeries .
The aim of this study is to examine the clinical efficiency of 5-FU application in the nasal cavity after a combination of endoscopic inferior turbinoplasty with one or more other nasal procedures (i.e. FESS, septoplasty, endoscopic middle turbinate surgery or endoscopic DCR).
2
Materials and methodology
The study was carried out in the department of otolaryngology at King Abdullah university hospital, which is JCIA accredited tertiary referral center. Institutional Ethical committee approval was obtained before starting.
The study was conducted in the period September 2015 and May 2016 and included 69 patients. Patient inclusion criteria included only those who underwent bilateral endoscopic inferior turbinoplasty surgeries in a combination with one or more of the following surgeries: bilateral functional endoscopic sinus surgery, septoplasty and/or bilateral endoscopic middle turbinate surgery. Exclusion criteria included patients with uncontrolled systemic illness, allergy to 5-flurouracil, unilateral nasal surgery, previous history of nasal surgery, pre-existing septal perforations or adhesions and age group of 13 or less.
Included patients were informed of the objective of the study, possible complications of the surgery with clear statement about using the 5-FU. All participants signed informed consent and they were assured that can withdraw from the study anytime they wish and their decision would not affect treatment provided.
2.1
Study design
A randomized double-blinded placebo controlled study. At the end of endoscopic nasal surgery two cottonoids were prepared by the assistant, one soaked with 5-FU and the other soaked with saline. Then the first one introduced to the one side and its content kept unknown to the surgeon and recorded in a special register. The same was done to the other side. The side of 5-FU application was assigned preoperatively based on a randomized number table and this information was only known to the assistant while the surgeon was kept blinded.
2.2
Preoperative evaluation
Physical examination focused on evaluating the presence of nasal septal deviation, septal spur, pre-existing septal perforation or adhesions, nasal polyps, discharge and post nasal drip evaluation. Patients were admitted one day before the surgery with routine baseline investigations like complete blood count and kidney function test.
2.3
Materials, setup and technique
Surgery was performed under general anesthesia. Pre-operative packing was done with 2% lidocaine and adrenaline 1/100,000 soaked cottonoids in all of our patients.
At the end of a combined endoscopic inferior turbinoplasty with one or more other nasal procedures surgery, application of 5-flurouracil was done in each patient unilaterally (right or left nasal cavity) according to a pre-prepared randomized table.
1 mL of 5-FU (1000 mg/20 mL) was diluted with 9 mL of 0.9% saline solution, 1 mL diluted 5-FU-soaked cottonoid (5 mg/mL) was applied under direct endoscopic visualization in one side in the nasal cavity between inferior turbinate and nasal septum and saline-soaked cottonoid was applied contralaterally and left for 5 min and then each side was irrigated with 60 cm 3 normal saline.
Polyvinyl alcohol coated nasal packings (8.5 cm in length) were inserted in both nostrils and were removed the next day prior to discharge.
2.4
Discharge and follow up
Patients were discharged at day 1 postoperatively after removing the Polyvinyl alcohol coated nasal packings, and were instructed to do nasal douches three times daily with warm normal saline using a 20 cm 3 bulb syringe. Patients were prescribed oral anti-staphylococcal antibiotics and simple analgesia for 7 days, nasal decongestant three times a day for 3 days, nasal ointment intra-nasally twice daily for 14 days and budesonide nasal steroids for 1 month.
Patients were followed up in outpatient clinics on the 7th, 30th, and 60th days postoperative. Follow up was conducted via a questionnaire and physical examination using rigid endoscope. Nasal condition was evaluated according to Lund-Kennedy endoscopic scoring system classification with adding a frank adhesion component specifying that adhesions either present or absent.
All follow ups were examined by the same examiner who was blinded to the side of 5-FU application, performed the exam after the application of 0.5% lidocaine spray using a rigid endoscope which was done on each visit to evaluate the formation of adhesions, infection, edema and granulation tissue in the nasal cavity and to perform removal of crusts.
The questionnaire included the following symptoms: nasal obstruction, discharge, pain, post nasal drip, smell change and headache, all of which were graded in a scale from (0 − 10), 10 being the highest score. Follow up physical examination focused on evaluating the presence of septal perforations, adhesions, post nasal drip, crustations, and discharge and nasal polyps.
2
Materials and methodology
The study was carried out in the department of otolaryngology at King Abdullah university hospital, which is JCIA accredited tertiary referral center. Institutional Ethical committee approval was obtained before starting.
The study was conducted in the period September 2015 and May 2016 and included 69 patients. Patient inclusion criteria included only those who underwent bilateral endoscopic inferior turbinoplasty surgeries in a combination with one or more of the following surgeries: bilateral functional endoscopic sinus surgery, septoplasty and/or bilateral endoscopic middle turbinate surgery. Exclusion criteria included patients with uncontrolled systemic illness, allergy to 5-flurouracil, unilateral nasal surgery, previous history of nasal surgery, pre-existing septal perforations or adhesions and age group of 13 or less.
Included patients were informed of the objective of the study, possible complications of the surgery with clear statement about using the 5-FU. All participants signed informed consent and they were assured that can withdraw from the study anytime they wish and their decision would not affect treatment provided.
2.1
Study design
A randomized double-blinded placebo controlled study. At the end of endoscopic nasal surgery two cottonoids were prepared by the assistant, one soaked with 5-FU and the other soaked with saline. Then the first one introduced to the one side and its content kept unknown to the surgeon and recorded in a special register. The same was done to the other side. The side of 5-FU application was assigned preoperatively based on a randomized number table and this information was only known to the assistant while the surgeon was kept blinded.
2.2
Preoperative evaluation
Physical examination focused on evaluating the presence of nasal septal deviation, septal spur, pre-existing septal perforation or adhesions, nasal polyps, discharge and post nasal drip evaluation. Patients were admitted one day before the surgery with routine baseline investigations like complete blood count and kidney function test.
2.3
Materials, setup and technique
Surgery was performed under general anesthesia. Pre-operative packing was done with 2% lidocaine and adrenaline 1/100,000 soaked cottonoids in all of our patients.
At the end of a combined endoscopic inferior turbinoplasty with one or more other nasal procedures surgery, application of 5-flurouracil was done in each patient unilaterally (right or left nasal cavity) according to a pre-prepared randomized table.
1 mL of 5-FU (1000 mg/20 mL) was diluted with 9 mL of 0.9% saline solution, 1 mL diluted 5-FU-soaked cottonoid (5 mg/mL) was applied under direct endoscopic visualization in one side in the nasal cavity between inferior turbinate and nasal septum and saline-soaked cottonoid was applied contralaterally and left for 5 min and then each side was irrigated with 60 cm 3 normal saline.
Polyvinyl alcohol coated nasal packings (8.5 cm in length) were inserted in both nostrils and were removed the next day prior to discharge.
2.4
Discharge and follow up
Patients were discharged at day 1 postoperatively after removing the Polyvinyl alcohol coated nasal packings, and were instructed to do nasal douches three times daily with warm normal saline using a 20 cm 3 bulb syringe. Patients were prescribed oral anti-staphylococcal antibiotics and simple analgesia for 7 days, nasal decongestant three times a day for 3 days, nasal ointment intra-nasally twice daily for 14 days and budesonide nasal steroids for 1 month.
Patients were followed up in outpatient clinics on the 7th, 30th, and 60th days postoperative. Follow up was conducted via a questionnaire and physical examination using rigid endoscope. Nasal condition was evaluated according to Lund-Kennedy endoscopic scoring system classification with adding a frank adhesion component specifying that adhesions either present or absent.
All follow ups were examined by the same examiner who was blinded to the side of 5-FU application, performed the exam after the application of 0.5% lidocaine spray using a rigid endoscope which was done on each visit to evaluate the formation of adhesions, infection, edema and granulation tissue in the nasal cavity and to perform removal of crusts.
The questionnaire included the following symptoms: nasal obstruction, discharge, pain, post nasal drip, smell change and headache, all of which were graded in a scale from (0 − 10), 10 being the highest score. Follow up physical examination focused on evaluating the presence of septal perforations, adhesions, post nasal drip, crustations, and discharge and nasal polyps.
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