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Evaluating the Role of Incision Height in Improving Trichiasis Surgery Outcomes

评估切口高度在改善倒睫手术结果中的作用

基本信息

批准号：
10349081
负责人：
EMILY W GOWER
金额：
$ 34.91万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-12-13 至 2021-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10349081
关键词：
Address Administrative Supplement Adult Affect Blindness COVID-19 Chlamydia Infections Cicatrix Clinical Trials Closure by clamp Communities Data Educational process of instructing Enrollment Ethiopia Eye Eyelash Eyelid structure Funding Geography Goals Grant Granuloma Guidelines Hair Removal Height Individual International Investigation Lead Manuals Masks Measures Modification Operative Surgical Procedures Outcome Participant Patients Population Postoperative Period Procedures Process Public Health Randomized Randomized Clinical Trials Recommendation Repeat Surgery Resources Risk Role Rotation Services Surgeon Surgical Clamps Surgical incisions Surgical sutures Time Touch sensation Trachoma Training Visit World Health Organization coronavirus disease cost follow-up improved innovation instrumentation prevent primary outcome programs secondary outcome success surgery outcome

项目摘要

NOTE: The project dates for this administrative supplement are March 1, 2020 – February 28, 2021. Project Abstract The primary objective of this randomized clinical trial is to determine whether the height of the incision made during trichiasis surgery affects surgical outcomes as measured within 12 months after surgery. The trial will be conducted in southern Ethiopia, where trachomatous trichiasis is endemic. Approximately 5,000 adult subjects will be enrolled. They will be randomized on a 1:1:1 basis to bilamellar surgery with an incision height of 3 mm, bilamellar surgery with incision targeted at 5 mm or Trabut. Sutures will be removed 2 weeks after surgery and participants will be examined again at 6 weeks, 12 months and 3 years after surgery (extended follow up due to covid-related shutdowns). The primary outcome is presence of post-operative trichiasis, defined as one or more lashes touching the eye or confirmed evidence of epilation. The secondary outcome is presence of a moderate or severe eyelid contour abnormality. Nearly 8 million individuals are in need of trichiasis surgery. If this trial is successful in reducing the rate of post-operative trichiasis by 25%, an estimated 300,000 individuals will be spared from post-operative trichiasis, which will allow reallocation of resources from repeat surgery to provide services to hundreds of thousands of individuals needing initial trichiasis surgery.

注：本行政副刊项目日期为2020年3月1日-2021年2月28日。项目摘要这项随机临床试验的主要目的是确定切口的高度是否倒睫手术影响手术后12个月内的手术结果。审判将是在埃塞俄比亚南部进行，那里沙眼倒睫是地方病。大约5000名成年受试者都会被录取。他们将按1：1：1的比例随机接受切开高度为3毫米的双椎板手术，以5 mm或后方为靶点的双椎板手术。缝合线将在手术后2周拆除参与者将在术后6周、12个月和3年再次接受检查(延长随访期限) 到Covid相关的关闭)。主要结果是术后出现倒睫，定义为一种或一种更多的睫毛接触到眼睛或确认有脱毛的证据。次要结果是出现了一个中度或重度眼睑轮廓异常。近800万人需要进行倒立手术。如果这项试验成功地将术后倒睫的发生率降低了25%，估计有30万人将避免术后倒立，这将使资源从重复手术重新分配到为数十万需要进行初始倒睫手术的患者提供服务。

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Effectiveness of Trachomatous Trichiasis Case-identification Approaches in Ethiopia.

埃塞俄比亚沙眼倒睫病例识别方法的有效性。

DOI：
10.1097/ede.0000000000001656
发表时间：
2023
期刊：
Epidemiology (Cambridge, Mass.)
影响因子：
0
作者：
Diallo,AlphaOumar;Bayissasse,Belay;Sisay,Alemayehu;Seyum,Dawit;Weaver,Jerusha;Munoz,Beatriz;Merbs,ShannathL;Gower,EmilyW
通讯作者：
Gower,EmilyW

A New Surgical Technique for Postoperative Trachomatous Trichiasis.