Effectiveness of sternocleidomastoid muscle flap in preventing of pharyngocutaneous fistula after total laryngectomy: An Open-label Clinical Trial.

Phase 3

Completed

• Conditions: sternocleidomastoid muscle flap in preventing of pharyngocutaneous fistula after total laryngectomy; Total laryngectomy; pharyngocutaneous fistula; sternocleidomastoid muscle flap

• Registration Number: TCTR20230916001
• Lead Sponsor: /A

Brief Summary

Pharyngocutaneous fistula is a challenging complication after total laryngectomy. Our study, without pre-operative radiotherapy, found no significant difference in fistula occurrence between the SCM flap group and the control group.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-04-04
• Study Start: 2023-09-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. patients who underwent total laryngectomy
2. aged up to 60 years
3. not received preoperative radiotherapy

Exclusion Criteria

Patients were required to have a preoperative hemoglobin level of 12.5 gm/dL or higher, and those with early-stage laryngeal cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified