Role of Cervical Fascia Flap in Decreasing the Incidence of Pharyngocutaneous Fistula After Total Laryngectomy

NCT07241611 | Completed

• 1 other identifier: MS.24.08.2855
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to evaluate the potential role of using the cervical fascia flap over the pharyngeal closure line to enhance healing and subsequently to decrease the incidence of pharyngocutaneous fistula after total laryngectomy.

Conditions

Malignant Tumor of the Larynx

Outcome Measures

Primary Outcomes (1)

• incidence of pharyngocutaneous fistula after total laryngectomy

  Four weeks

Secondary Outcomes (2)

• subjective assessment of the swallowing function after surgery

  three months

• objective assessment of the swallowing function after surgery

  Three months

Study Arms (2)

cervical fascia flap group

ACTIVE COMPARATOR

Procedure: Total laryngectomy

conventional repair group

ACTIVE COMPARATOR

Procedure: Total laryngectomy

Interventions

Total laryngectomy PROCEDURE

pharyngeal repair after total larygectomy

cervical fascia flap group; conventional repair group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients who will undergo total laryngectomy for advanced laryngeal carcinoma in the study duration.

You may not qualify if:

• Presence of extra-laryngeal extension.
• Patients undergoing partial pharyngectomy.
• Previous neck irradiation.
• Previous neck surgery.
• Patients' refusal to participate in the study.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (4)

• Zorlu ME, Kertmen C, Aysel A, Yilmaz F, Dalgic A, Muderris T. Use of Cervical Fascia to Prevent Pharyngocutaneus Fistula After Total Laryngectomy. Laryngoscope. 2024 Dec;134(12):4964-4970. doi: 10.1002/lary.31606. Epub 2024 Jun 28.

  PMID: 38940495 BACKGROUND

• Wang M, Xun Y, Wang K, Lu L, Yu A, Guan B, Yu C. Risk factors of pharyngocutaneous fistula after total laryngectomy: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2020 Feb;277(2):585-599. doi: 10.1007/s00405-019-05718-9. Epub 2019 Nov 11.

  PMID: 31712878 BACKGROUND

• Eid AM, Ebada HA, El-Fattah AMA, Tawfik A. Platelet-rich fibrin: an autologous biomaterial for healing assistance of pharyngeal repair in total laryngectomy. Eur Arch Otorhinolaryngol. 2021 Feb;278(2):463-470. doi: 10.1007/s00405-020-06404-x. Epub 2020 Oct 3.

  PMID: 33009930 BACKGROUND

• Park J, Chang C, Kwon D. Use of fibrin adhesive for preventing pharyngocutaneous fistula in total laryngectomy. Am J Otolaryngol. 2020 Nov-Dec;41(6):102674. doi: 10.1016/j.amjoto.2020.102674. Epub 2020 Aug 13.

  PMID: 32836041 BACKGROUND

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: July 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)