Effect of Intra-Operative Topical 5-Fluorouracil Post-Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial

Abstract

Introduction: Endoscopic nasal surgery has numerous potential adverse effects, adhesions are at the top of the list. 5-fluorouracil (5-FU), which is an analogue of pyrimidine, is utilized in a wide variety of areas for the purpose of preventing adhesions. In the present investigation, our purpose was to analyze the impact of intra-operative application of 5-flurouracil in the nasal cavity following FESS, as well as to evaluate both subjective and objective outcomes.

Materials and methods: Following the acquisition of institutional ethical approval, a testing procedure that was randomized, prospective, and double-blinded was carried out. After the FESS, a cotton swab soaked in 1 mL of 5-flurouracil at 5 mg/mL was inserted in one side of the nasal cavity and a saline-soaked one in the other. Both of these swabs were kept in place for a period of five minutes. Postoperatively, patients were assessed over 6 months duration, wherein, adhesions, discharge, crustation, edema and polypoidal changes were analyzed. Subjective symptoms such as nasal block, nasal discharge and loss of smell were also assessed.

Results: At the one-week follow-up, the test group had a significantly higher incidence of adhesions (32% vs. 11.76%, respectively) (p = 0.004) than the control group. Mucosal edema, crusting, polypoidal change and nasal discharge continued to significantly diminish in both groups. Furthermore, improvement in smell perception in the test group at the 20th week post-operatively was statistically significant (p= 0.014).

Conclusions: Adhesions are less common in the early postoperative period in individuals who underwent FESS with or without polypectomy when 5-FU is administered topically. There is also an improvement in smell perception with a reduction of mucosal edema, crusting, polypoidal change and nasal discharge enabling better healing.

Keywords: 5-Fluorouracil; Adhesions; Functional Endoscopic Sinus Surgery; Outcomes; Randomized Control Trial; Synechia.

Fig 1

Endoscopic view of the left nasal cavity showing 5-FU-soaked cotton pledget placed in the middle meatus

Fig 2

Bar diagram depicting comparison of Total LKS in Group A and Group B

Fig 3

Bar chart showing analysis of intra-nasal adhesions at 1^st week and 20^th week.