Fistula Care Project, EngenderHealth, 440 9th Ave, New York, NY, USA.
BMC Pregnancy Childbirth. 2010 Nov 10;10:73. doi: 10.1186/1471-2393-10-73.
Maternal outcomes in most countries of the developed world are good. However, in many developing/resource-poor countries, maternal outcomes are bleaker: Every year, more than 500,000 women die in childbirth, mostly in resource-poor countries. Those who survive often suffer from severe and long-term morbidities. One of the most devastating injuries is obstetric fistula, occurring most often in south Asia and sub-Saharan Africa. Fistula treatment and care are available in many countries across Africa and Asia, but there is a lack of reliable data around clinical factors associated with the success of fistula repair surgery. Most published research has been retrospective. While these studies have provided useful information about the care and treatment of fistula, they are limited by the design. This study was designed to identify practices in care that could lead to the design of prospective and randomized controlled trials.
Self-administered questionnaires were completed by 40 surgeons known to provide fistula treatment services in Africa and Asia at private and government hospitals. The questionnaire was divided into three parts to address the following issues: prophylactic use of antibiotics before, during, and after fistula surgery; urethral catheter management; and management practices for patients with urinary incontinence following fistula repair.
The results provide a glimpse into current practices in fistula treatment and care across a wide swath of geographic, economic, and organizational considerations. There is consensus in treatment in some areas (routine use of prophylactic antibiotics, limited bed rest until the catheter is removed, nonsurgical treatment for postsurgical incontinence), while there are wide variations in practice in other areas (duration of catheter use, surgical treatments for postsurgical incontinence). These findings are based on a small sample and do not allow for recommending changes in clinical care, but they point to issues for possible clinical trial research that would contribute to more efficient and effective fistula care.
The findings from the survey allowed us to consider clinical practices most influential in the cost, efficacy, and safety of fistula treatment. These considerations led us to formulate recommendations for eight randomized controlled trials on the following subjects: 1) Efficacy/safety of short-term catheterization; 2) efficacy of surgical and nonsurgical therapies for urinary incontinence; 3) technical measures during fistula repair to reduce the incidence of post-surgery incontinence; 4) identification of predictive factors for "incurable fistula"; 5) usefulness of urodynamic studies in the management of urinary incontinence; 6) incidence and significance of multi-drug resistant bacteria in the fistula population; 7) primary management of small, new fistulas by catheter drainage; and 8) antibiotic prophylaxis in fistula repair.
在大多数发达国家,产妇结局良好。然而,在许多发展中国家和资源匮乏国家,产妇结局则不容乐观:每年,有超过 50 万名妇女在分娩时死亡,其中大多数发生在资源匮乏国家。那些幸存下来的人往往患有严重且长期的疾病。最具破坏性的损伤之一是产科瘘,这种损伤在南亚和撒哈拉以南非洲最为常见。在非洲和亚洲的许多国家都可以进行瘘管治疗和护理,但与瘘管修复手术成功相关的临床因素缺乏可靠数据。大多数已发表的研究都是回顾性的。虽然这些研究为瘘管的护理和治疗提供了有用的信息,但它们受到设计的限制。本研究旨在确定可能导致前瞻性和随机对照试验设计的护理实践。
在非洲和亚洲的私立和公立医院中,为 40 名已知提供瘘管治疗服务的外科医生发放了自填式问卷。问卷分为三部分,分别针对以下问题:瘘管手术前、手术中和手术后预防性使用抗生素;尿道导管管理;以及瘘管修复后尿失禁患者的管理实践。
研究结果提供了对广泛的地理、经济和组织考虑因素下的瘘管治疗和护理现状的初步了解。在某些领域(常规使用预防性抗生素、在导管拔出前限制卧床休息、对术后尿失禁进行非手术治疗)的治疗存在共识,而在其他领域(导管使用时间、术后尿失禁的手术治疗)的实践存在广泛差异。这些发现基于小样本,不允许推荐改变临床护理,但它们指出了可能有助于更有效和高效的瘘管护理的临床试验研究的问题。
调查结果使我们能够考虑对瘘管治疗的成本、疗效和安全性最有影响的临床实践。这些考虑促使我们制定了八项随机对照试验的建议,主题如下:1)短期导管插入的疗效/安全性;2)手术和非手术治疗尿失禁的疗效;3)瘘管修复过程中的技术措施,以降低术后尿失禁的发生率;4)“不可治愈瘘管”的预测因素的确定;5)尿动力学研究在尿失禁管理中的有用性;6)瘘管人群中多药耐药菌的发生率和意义;7)通过导管引流对小的、新的瘘管进行初步管理;8)瘘管修复中的抗生素预防。