Descriptive study of the anatomical variations of the Superficial Temporal artery and the Posterior Auricular Artery in the patients with unilateral microtia and its implications on the surgical outcomes in Auricular reconstruction surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To look for anatomical variations in Superficial Temporal artery and Posterior Auricular artery by measuring their diameter and branching patterns
研究概览
简要总结
A purposive sampling of all patients attending the ENT clinics at AIIMS OPD will be undertaken. Patients with Unilateral Microtia will be evaluated and those fulfilling the inclusion and exclusion criteria will be recruited. They will be screened for severe facial abnormalities, chest wall abnormalities and low hairline microtia. Those deemed unfit for surgery under General Anesthesia by the Anesthesiology team will be excluded and will be provided other suitable alternative treatment options.
Patients recruited for the study will be explained in complete detail about the procedure and an Informed Written consent will be sought.
Following this, detailed workup and assessment of the patients will be done and a basic proforma including demographic and clinical details will be filled.
Clinical Photographs for medical, research and academic purpose will be taken only after due consent from the patients.
Subsequent to this, patients will undergo CT Angiography. The diameter of STA and PAA will be measured on CT Angiography. Branching pattern of STA will also be assessed.
The surgery will be done in a staged manner, utilizing Modified Nagata technique employing Temporoparietal flap based on Superficial Temporal Artery and customized to suit the individual patient. Intra operative proforma including size, shape and location of flap, time taken for temporoparietal flap harvesting and total time of surgery from draping to closure will be filled separately for both stages.
There would be minimum 3 months gap between both stages. Patients will stay admitted in the ENT ward for few days after each stage during which they will be closely observed to look for any complications, and will be subsequently discharged and will be followed up in OPD.
Proforma will be updated for details in the post-op period to look for any complication.
The socio-demographic and clinical variables will undergo tabulation, and measures of central tendency will be computed for analysis. Quantitative variables will be presented as mean values, while categorical variables will be expressed as frequencies and percentages. Descriptive statistics will be employed to analyze the data obtained.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All cases of unilateral microtia undergoing auricular reconstruction aged more than 6 years.
- •Any gender.
- •Individuals giving consent to participate in the study Willing to give written informed consent.
- •Chest circumference of atleast 60 cm at the level of xiphoid process.
排除标准
- •Patient who is not willing to participate in the study.
- •Patient who is unfit for surgery under general anaesthesia.
- •Patients with low hairline microtia.
- •Patients with less than 6 years of age.
- •Patients who have undergone previous ear surgery.
- •Patients with severe facial abnormalities.
- •Patient with chest wall abnormalities.
- •Patient for whom computed tomography is contraindicated.
结局指标
主要结局
To look for anatomical variations in Superficial Temporal artery and Posterior Auricular artery by measuring their diameter and branching patterns
时间窗: CT Angiography will be done before these patients undergo surgery
次要结局
- To examine the post operative surgical outcomes of auricular reconstruction surgery in cases of unilateral microtia based on their vascular anatomy.(During follow up of patients in the post operative period)
研究者
STAVAN JARIWALA
All India Institute Of Medical Sciences (AIIMS), New Delhi