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Efficacy of Transconjunctival Approach for the Management of Fractures involving Infraorbital Rim: A Randomized Controlled Trial

Comparison of the Efficacy of Transconjunctival Approach without Lateral Canthotomy with Infraorbital Approach for the Management of Fractures involving Infraorbital Rim: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076453
Enrollment
40
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: T889- Complication of surgical and medical care, unspecified Health Condition 2: Z768- Persons encountering health services in other specified circumstances Health Condition 3: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: Transconjunctival approach for management of infra orbital rim fracture: transconjunctival approach without lateral canthotomy is used for the management of infra orbital rim fracture i

Sponsors

Geetanjali Dental & Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between age of 18-70 years of both genders. 2. Patients with clinical and radiological evidence of infraorbital rim fractures which requires open reduction and internal fixation. 3. Healthy patients falling under ASA I and ASA II 4. Subjects able and willing to provide written informed consent and compliant with study procedure.

Exclusion criteria

Exclusion criteria: 1. Patients with contused or lacerated wound in lower eyelid. 2. Patients with open globe injury or hyphema, conjunctival pathology, ocular surface or glaucoma. 3. Patients having any systemic or local immunodeficiency. 4. Patients with osteoporosis and osteopetrosis 5. Patients with medical co-morbidities 6. Having any blood coagulation impairment. 7. Have been suffering with uncontrolled diabetes or other systemic diseases.

Design outcomes

Primary

MeasureTime frame
INTRA OPERATIVE PARAMETERS 1) Surgical time to expose the fracture site 2) Surgeon’s satisfaction for the stability of plate POST OPERATIVE PARAMETERS 1) Pain 2) Eyelid oedema 3) Ecchymosis 4) Epiphora 5) Scar Timepoint: INTRA OPERATIVE PARAMETERS 1) Surgical time to expose the fracture site 2) Surgeon’s satisfaction for the stability of plate POST OPERATIVE PARAMETERS 1) Pain on 3rd day, 7th day, 15th day and 1 month 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month 4) Epiphora on 3rd day, 7th day, 15th day and 1 month 5) Scar on 3rd day, 7th day, 15th day and 1 month—

Secondary

MeasureTime frame
POST OPERATIVE PARAMETERS • Ectropion • Entropion • Infection • Paresthesia/neurosensory involvement • Malunion/nonunion/delayed union • Exposure of plates/screws Timepoint: POST OPERATIVE PARAMETERS • Ectropion on 3rd day, 7th day, 15th day and 1 month • Entropion on 3rd day, 7th day, 15th day and 1 month • Infection on 3rd day, 7th day, 15th day and 1 month • Paresthesia/neurosensory involvement on 3rd day, 7th day, 15th day and 1 month • Malunion/nonunion/delayed union on 3rd day, 7th day, 15th day and 1 month • Exposure of plates/screws on 3rd day, 7th day, 15th day and 1 month—

Countries

India

Contacts

Public ContactDr Shallu Bansal

Geetanjali Dental and Research Insitute

drshallu23@gmail.com9116155666

Outcome results

None listed

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