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use of muscle flap in reducing leak rate after radiation therapy and surgery for larynx cancer

Utility of pectoralis major myofascial flap in reducing pharyngocutaneous fistula rates after salvage total laryngectomy - PMMF-RCT

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014337
Enrollment
160
Registered
2018-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients suffering from laryngeal cancer

Interventions

Intervention1: PMMF ARM: All previously treated patients of larynx and hypopharynx carcinoma with biopsy proven recurrence / residual disease, suitable for salvage total laryngectomy and primary closu

Sponsors

Tata memorial hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Recurrent / residual lesions irrespective of histology of larynx and hypopharynx previously treated with radiotherapy/ chemoradiotherapy undergoing salvage total laryngectomy. 2-Patients in whom primary pharyngeal closure is possible with no need for pharyngeal reconstruction to augment pharyngeal mucosa closure. 3- Patients with age between 18 years -70 years 4- Patients with dysfunctional larynx as deemed by the tumor board decision with negative histopathology report. Dysfunctional larynx may include: persistent tracheostomy, chondronecrosis, persistent nasogastric tube use, and aspiration

Exclusion criteria

Exclusion criteria: 1-Treatment naive patient with no prior radiotherapy/chemo-radiotherapy. 2-Patients suitable for conservation laryngeal surgery. 3-Patients requiring pharyngeal reconstruction for pharyngeal mucosa closure in whom primary pharyngeal closure not possible.

Design outcomes

Primary

MeasureTime frame
To assess the utility of pectoralis major myofascial flap in reducing pharyngocutaneous fistula rates after salvage total laryngectomy.Timepoint: At the end of completion of treatment

Secondary

MeasureTime frame
To identify factors affecting pharyngocutaneous fistula in salvage total laryngectomy.Timepoint: At the end of completion of treatment

Countries

India

Contacts

Public ContactDr. Gouri Pantvaidya

Tata Memorial Hospital

docgouri@gmail.com022241770006212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026