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Comparison of Various methods of Reconstruction of Full thickness Cheek defects following Oral Carcinoma resection

Comparison between various modalities of Reconstruction and Outcomes for Full thickness Oromandibular defects following Tumor excision : A single center Prospective Factorial Randomized Control trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111071
Enrollment
24
Registered
2026-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Reconstruction of Full thickness cheek defect following oncologic resection in Oral carcinoma: Free flap with pedicled flap reconstruction, Chimeric Free flap with 2 paddles, Double fre

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 years and above, Patients requiring Full thickness reconstruction for various malignant conditions of oral cavity, Willingness to comply with the study protocol, including follow-up visits and assessments, Adequate medical fitness for surgery as assessed by the treating surgical team, Willingness to participate in follow-up assessments as required by the study protocol.

Exclusion criteria

Exclusion criteria: Patients with distant metastasis of oral carcinoma, Patients unwilling to undergo the required follow- up assessments as per the study protocol.

Design outcomes

Primary

MeasureTime frame
To compare the functional, aesthetic, and surgical outcomes and quality of life of the 3 types of reconstructions, i.e. Double free flaps, Bipedicled free flap, and Free flap and Pedicled flap among the patients undergoing surgery for Full thickness cheek defect reconstruction following tumor excision in Burns & Plastic Surgery department, AIIMS, Bhubaneswar.Timepoint: 6 months postop

Secondary

MeasureTime frame
To analyze and compare mean Hospital stay, rate of complications and need for re exploration and repeat surgery. To assess the early and late post operative complications such as flap congestion, need for re-operation, flap failure, fistula formation, plate extrusion, bleeding, and infection in the 3 groups. Timepoint: at the time of discharge and subsequent follow ups;NILTimepoint: NIL

Countries

India

Contacts

Public ContactVidush Kumar

AIIMS Bhubaneswar

plastic_santanu@aiimsbhubaneswar.edu.in9831603491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026