Skip to content

Comparison of Submental Island Pedicle Flap vs Radial Forearm Free Flap for oral cavity reconstruction.

submental island pedicled flap vs Radial forearm free flap for reconstruction of oral cavity (SIRFROC) : a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032397
Enrollment
60
Registered
2021-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C060- Malignant neoplasm of cheek mucosa Health Condition 2: C020- Malignant neoplasm of dorsal surface of tongue Health Condition 3: C039- Malignant neoplasm of gum, unspecified Health Condition 4: C008- Malignant neoplasm of overlappingsites of lip

Interventions

Intervention1: SUBMENTAL ISLAND PEDICLE FLAP: in this we will compare SIPF flap will be used for reconstruction of oral cavity Intervention2: Radial forearm free flap: in this we will use RFFF will b

Sponsors

AIIMS JODHPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.1 Oral squamous cell carcinoma T1-T3 tongue, buccal mucosa including commissure of mouth, lower or upper alveolo-buccal complex, and lip. 2.N0 -N1 disease 3. Patient willing to participate in the study

Exclusion criteria

Exclusion criteria: 1.Clinically positive lymph nodes/ nodes at level 1A. 2.Primary disease infiltrating the mylohyoid muscle (e.g. primary at the floor of mouth). 3.Patients with previous neck dissection or neck irradiation. Anticipated surgical defects that are too large for repair with the SIPF (more than 40 cm2).

Design outcomes

Primary

MeasureTime frame
1.To compare flap success rate between SIPF vs RFFFTimepoint: 3 months

Secondary

MeasureTime frame
1.To compare operative time, length of hospital stays. 2.Rate of revision (salvage) surgery for flap loss. To compare postoperative outcomes , cosmetic outcomes and other complications between two arms.Timepoint: 3months

Countries

India

Contacts

Public ContactDr Mohit

AIIMS jodhpur

drjvishnoi@gmail.com9455061569

Outcome results

None listed

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