Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures

NCT03813732 | Unknown DMC

• 1 other identifier: CEBD-CU-2019-01-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

All cases will undergo surgery under general anesthesia. Evaluation of patients with suspected orbital fracture should involve radiologic examination, motility test, diplopia field test and exophthalmometry. Plain X-ray films, although rarely used, with the Caldwell and Waters view may be done as a screening evaluation for possible fractures and foreign bodies. An orbital computed tomography, the gold standard in trauma, CT with contiguous thin axial and coronal sections should be ordered to confirm the diagnosis and plan for treatment Postoperative care: Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics.

Conditions

Orbital Fractures

Keywords

trans-conjunctival approach

Outcome Measures

Primary Outcomes (1)

• Assessment of the esthetics

  Visual analog scale numerical1-10

  3 months

Secondary Outcomes (1)

• Infection

  3month

Study Arms (1)

orbital fracture

OTHER

using the trans-conjunctival approach with lateral canthotomy

Procedure: orbital fracture

Interventions

orbital fracture PROCEDURE

using the trans-conjunctival approach alone in restoring the esthetics compared with using it along in addition to lateral canthotomy which is important in providing wider surgical area

orbital fracture

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age group: from 15 to 60 years old.
• Patients with blow-out fractures.

You may not qualify if:

• Patients suffering from dermatological diseases,

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Alasr elany

Giza, Manial, 12112, Egypt

Location

Related Publications (1)

• Lee HB, Lee SH. New anthropometric data for preoperative planning in orbital wall fracture treatment: the use of eyelid drooping. Arch Craniofac Surg. 2018 Dec;19(4):248-253. doi: 10.7181/acfs.2018.02096. Epub 2018 Dec 27.

  PMID: 30613085 RESULT

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Central Study Contacts

Khaled M Amr, Prof

CONTACT

01006029231; Khaledamr82@hotmail..com

Nashwa M Osama

CONTACT

01006835113; Nashwaosama@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes: outcome Method of measurement Measuring unit Primary outcome Assessment of the esthetics. Visual analog scale Numerical Secondary outcome pain Visual analog scale Numerical (1-10)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant researcher in national research centre

Model Details: 1. Pre-operative phase: Patients will be subjected to: 1. Case history including personal data, medical, surgical and family history. 2. Clinical examination. 3. Preoperative anesthesia assessment for fitness for general anesthesia. 4. Treatment planning. 2. Operative phase: All cases will undergo surgery under general anesthesia. 3. Postoperative care: Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics. 4. Postoperative evaluation and follow-up: 12\) Outcomes: outcome Method of measurement Measuring unit Primary outcome Assessment of the esthetics. Visual analog scale Numerical Secondary outcome pain Visual analog scale Numerical (1-10)

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 23, 2019
• Study Start: January 15, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2021
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

EG (1)