A prospective study - one flap palatoplasty technique for complete unilateral cleft palate
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess the surgical outcome of one flap palatoplasty
研究概览
简要总结
| The cleft lip and palate (CLP) is one of the most common congenital malformations in the human race, it is caused by lack of fusion of the embryonic facial processes. The anatomic impairment appears as a cleft lip and / or palate, and it may occur with a frequency of 1:700 births. |
Surgical repair of primary cleft palate is a procedure for anatomical and functional reconstruction of this structure,which is performed most commonly by two flap palatoplasty technique introduced by “BARDACH†more than 45 years ago and is most commonly used procedure in United states .
The main goal of palatoplasty is not only restoring the anatomy of the palate , but also promote an adequate velopharyngeal function that consequently provides conditions for the production of speech but the main disadvantage associated is maxillary growth disturbance secondary to surgical scarring following palatal repair.Further following two flap palatoplasty results in bilateral raw surface left for healing by granulation tissue formation and the associated increased scarring causing increased maxillary growth disturbance.
Thus a surgical technique using only one mucoperiosteal flap from the noncleft side was introduced by ROSSEL-PERRY et al in the year 2015 at lima, peru (1-flap method) reducing the extent of the surgery and its potential nondesirable effects over the palate. There is a paucity of literature supporting the outcome of this technique. Hence we recommend studies to evaluate this technique for its appropriateness to be an alternative for palatal repair in patients with complete unilateral cleft palate with minimal side effects. The purpose of this study is to evaluate the utility of this technique for unilateral cleft palate repair.
PROCEDURE :
Patient consent will be obtained prior to the procedure
- These study include 10 healthy patients who are non syndromic ,irrespective of sex has to undergo for surgery for one flap palatoplasty for primary cleft palate deformity at age group of 12 months to 3 years at oral and maxillofacial unit Coorg Institue of Dental sciences
- All the patients will be undergoing routine hemogram investigation before the procedure . they will be prepared in a standard manner and taken up under proper aseptic condition for the procedure
- Patient will be given standard antibiotics of beta lactam/cephalosporin group as well as analgesic post –operatively
- This study will contain assessment of fistula site ( pittsburgh classification system ) velopharyngeal dysfunction evaluated by speech pathologist henningson et al flap blood supply is assessed according to journal of wound care and assessment of infection post -operatively
- assessment of palatal index grading pre-operatively based on Percy -Rossell -Perry et al
- assessment of surgical time intra -operatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Month(s) 至 3.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients Who Has To Undergo Surgery For Unilateral Cleft lip And Palate
- •Patient Who Are non syndromic ,irrespective of the sex are included in the study
- •Age group-12 months to 3 years.
排除标准
- •Patient who will not cooperate with follow-up schedule
- •Previously repaired cases of cleft palate.
结局指标
主要结局
To assess the surgical outcome of one flap palatoplasty
时间窗: within 2 years
次要结局
- to assess the improvement in speech following surgery for cleft palate repair(within two years)
