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Part of a muscle(fascia lata)from the thigh during reconstruction helps in preventing drooling of saliva/food particles from the mouth.

Efficacy of Fascia Lata suspension sling in improving oral competence among patients undergoing composite resection and reconstruction in oral cavity Squamous Cell Carcinoma â?? A Randomized Controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035750
Enrollment
62
Registered
2021-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: C031- Malignant neoplasm of lower gum Health Condition 2: C048- Malignant neoplasm of overlappingsites of floor of mouth Health Condition 3: C008- Malignant neoplasm of overlappingsites of lip Health Condition 4: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth Health Condition 5: C028- Malignant neoplasm of overlappingsites of tongue

Interventions

Intervention1: Composite resection and reconstruction with tensor fascia lata suspension sling: Fascia lata is harvested by means of a longitudinal incision in the thigh. Reconstruction of oral slin

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult Population age 18 years or older 2. ECOG Performance Status of 0 to 2 3. Carcinoma of the alveolar buccal complex requiring composite resection and reconstruction 4. Stage III - IV (As per AJCC 8th Classification)

Exclusion criteria

Exclusion criteria: 1. Patients who have not undergone radical surgery 2. Patients with anterior 2/3rd tongue, upper alveolus and maxillary sinus carcinoma 3. Patients who have distant metastases at presentation 4. Patients who are already having marginal mandibular nerve dysfunction 5. Patient undergoing salvage surgery following concurrent chemoradiotherapy/ radiotherapy

Design outcomes

Primary

MeasureTime frame
Proportion of significant droolingTimepoint: At 6weeks after surgery—

Secondary

MeasureTime frame
Change in Quality-of-lifeTimepoint: At 6 weeks and 6 months after surgery;ComplicationsTimepoint: 30 days after surgery;Drooling severityTimepoint: 6 months after surgery—

Countries

India

Contacts

Public ContactDR KAMALA KANNAN S

JIPMER

drpenumadu@gmail.com9042092936

Outcome results

None listed

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