Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

Phase 1

Recruiting

• Conditions: Laryngeal Leucoplakia; Glottic Web of Larynx; Laryngeal Stenosis; Laryngeal Papilloma; Glottic Carcinoma; Laryngeal Polyp
• Interventions: Drug: Curcumin; Drug: Mitomycin-C

• Registration Number: NCT05688488
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

To provide a novel therapy idea and method to solve the clinical problem of postoperative adhesion of bilateral vocal cords, patients enrolled in this study will be applied with curcumin on both wound sites of bilateral vocal cords after the surgery on the bilateral vocal cord endoscopically.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-28
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-15
• Study First Posted: 2023-01-18
• Study Start: 2023-05-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with bilateral vocal cord diseases who are going to undergo resection of bilateral vocal cord lesions endoscopically.
2. Patients with bilateral vocal cord adhesion who are going to undergo incision of bilateral vocal cord adhesion endoscopically.

Exclusion Criteria

1. Patients with other laryngeal diseases.
2. Patients with cardiac and pulmonary insufficiency.
3. Patients unable to cooperate with the follow-up on time after surgery.
4. Patients who refuse to sign the informed consent after notification.
5. Patients who have a severe allergic disease or allergic history to a variety of drugs.
6. Other circumstances that are not appropriate to be included in the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin	Curcumin	-
Mitomycin	Mitomycin-C	-

Primary Outcome Measures

Name	Time	Method
Number of participants with laryngeal web formation as assessed by videolaryngoscope	1 year postsurgery	All participants received the videolaryngoscope every month post-surgery, and a laryngeal web is defined as a visible adhesion whose length reached 1 mm or greater.

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China