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Comparing a dye based blood flow test with the surgeon assessment to prevent flap damage and complications after chest muscle flap surgery in patients with head and neck cancer.

Evaluation of Indocyanine Green Angiography Versus Clinical Judgment in Reducing Flap Necrosis and Postoperative Morbidity in Pectoralis Major Myocutaneous Flap Reconstruction for Head and Neck Cancer A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103597
Enrollment
110
Registered
2026-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: C021- Malignant neoplasm of border of tongue Health Condition 2: C028- Malignant neoplasm of overlappingsites of tongue Health Condition 3: C029- Malignant neoplasm of tongue, unspecified Health Condition 4: C020- Malignant neoplasm of dorsal surface of tongue Health Condition 5: C022- Malignant neoplasm of ventral surface of tongue Health Condition 6: C030- Malignant neoplasm of upper gum Health Condition 7: C031- Malignant neoplasm of lower gum Health Condition 8: C039- Mal

Interventions

Intervention1: Indocyanine Green (ICG) Fluorescence Angiography group: Patients in the intervention arm will undergo intraoperative assessment of flap perfusion using Indocyanine Green (ICG) fluoresce

Sponsors

Dr Shridhar Hosamani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age greater than eighteen years and less than seventy five years. 2.Histologically confirmed squamous cell carcinoma of the oral cavity. 3.Planned for PMMC flap reconstruction after resection. 4.No known allergy to iodides or ICG dye. 5.Willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1.Recurrent and Non-resectable head and neck cancers 2.Need for free flap reconstruction. 3.Prior chest wall surgeries or radiation. 4.Patient not fit for surgery 5.Patient not giving consent for participation in this study 6.Patients with diseases with poor healing rates and immunocompromised status 7.Known allergy to iodine or ICG. 8.severe hepatic dysfunction, pregnant/lactating women.

Design outcomes

Primary

MeasureTime frame
Flap-related complications- mainly partial necrosis 1. Flap dehiscence 2. Re-suturing 3. Re-Operations 4. Oro-Cutaneous fistula Timepoint: 30 days post operative period—

Secondary

MeasureTime frame
1.Starting Orals 2.Hospital stays 3.Starting adjuvant Radiotherapy Timepoint: 2 Weeks, 4 weeks & before adjuvant RT—

Countries

India

Contacts

Public ContactDr Hemant Kumar Singh

AIIMS Mangalagiri

hemant.surgicaloncology@aiimsmangalagiri.edu.in8903306321

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026