The Effect of Topical Application of 5-fluorouracil during Functional Endoscopic Sinus Surgery(FESS) in the prevention of nasal adhesions post-surgery.

Not yet recruiting

Conditions: Other specified bacterial diseases,

Registration Number: CTRI/2021/03/032286

Lead Sponsor: Dr Lekhaa M

Brief Summary: Functional Endoscopic Sinus Surgery(FESS) is a frequently performed surgery. Formation of post-operative adhesions is a complication that leads to recurrence of disease and need for revision surgery. 5 Fluorouracil is an anti-metabolitic agent that has been shown to reduce adhesions post surgery. In this study, patties soaked in diluted 5-FU will act as the test and patties soaked in Normal Saline will act as the control, placed in one side of the nasal cavity, in a randomized manner, and the formation of adhesions will be studied via serial follow-ups. Hypothesis : The intra-operative usage of topical 5-FU in the nasal cavity prevents the formation of adhesions and synechiae.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 68

Inclusion Criteria

1 Patients of either age between 18 to 60 years 2 Diagnosis of bilateral chronic sinusitis who have had no relief with maximum medical therapy 3 Similar Lund Makay Scoring on both sides.

Exclusion Criteria

Revision Endoscopic Sinus surgery Uncontrolled systemic illness Known allergy to 5 FU Pregnancy and lactation Pre-existing septal perforation or adhesion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Formation of adhesions post-operatively	At 2nd 4th and 12th week postoperatively

Secondary Outcome Measures

Name	Time	Method
Reduction in formation of nasal crusting postoperatively	At 2nd 4th and 12th week postoperatively

Trial Locations

Locations (1): Sri Ramachandra Institute of Medical Education and Research
🇮🇳
Chennai, TAMIL NADU, India
Sri Ramachandra Institute of Medical Education and Research
🇮🇳Chennai, TAMIL NADU, India
Dr Lekhaa M
Principal investigator
9600000644
M4420006@sriramachandra.edu.in