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临床试验/NCT04267757
NCT04267757已完成不适用

Transperineal Repair of Primary Obstetric Rectovaginal Fistulas With Fecal Incontinence Using Fistulectomy, Sphincteroplasty and With or Without Bulbocavernosus Muscle Flap:Surgical Pitfalls and Prevention of Recurrence

Zagazig University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
rectovaginal fistula repair with or without Martius flap

研究概览

简要总结

Introduction: A rectovaginal fistula (RVF) is an epithelium-lined abnormal tract between the rectum and the vagina and is often a challenging problem for both the patients and to the surgeons. In literature, there is still debate regarding the best treatment options for rectovaginal fistulas.

Aim: To assess the results of the treatment of rectovaginal fistulas with incontinence and impaired anal tonus using fistulectomy, sphincteroplasty with or without bulbocavernosus muscle (Martius) flap.

Materials and Methods: A total of 22 consecutive patients with simple RVFs were included and assigned to transperineal repair. The patients were divided into two groups , group1: with Martius flap; group2: without Martius flap .Postoperatively, patients were followed up for one year at the outpatient clinic or through telephone interviews with specific questionnaires to collect information on the status of fecal control, flatus, or fecal leakage from the vagina.

详细描述

Introduction:

Rectovaginal fistulas represent an often devastating condition in patients and a challenge for surgeons because of their irritating and embarrassing symptoms and high failure rate after repair.Patients with rectovaginal fistulas typically present with complaints of passage of flatus or feces from the vagina with painful skin excoriation.

(1) The most common etiological cause of rectovaginal fistulas is obstetrical trauma. When obstructed labor is unrelieved, the presenting fetal part is impacted against the soft tissues of the pelvis leading to ischemic vascular injury and subsequent tissue necrosis and fistula formation. Other predisposing factors include forceps delivery, midline episiotomy, and third or fourth-degree perineal lacerations.( 2).

Evaluation of a patient with rectovaginal fistula includes a detailed history, examination of the rectum, vagina, and perineal body. The perineal body is often thin or nearly nonexistent in patients with sphincter injuries secondary to obstetrical trauma. Endoanal ultrasonography and pelvic Magnetic Resonance Imaging (MRI) to confirm sphincter injury and may provide valuable information before a planned repair. MR is the modality of choice for disease staging (sensitivity 91%) (3).

( Sagittal T2 MR imaging shows communication between the rectum tumor and the vagina) The experience of the surgeon and the previous attempts at repair are also important factors of the success rate of the operations [4)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1- Rectovaginal fistula caused by obstetric problems 2- Female >20 years

排除标准

  • other causes of rectovaginal fistula as Crohn's disease or malignant fistula
  • complex and recurrent fistula -

结局指标

主要结局

rectovaginal fistula repair with or without Martius flap

时间窗: 1 year

detect recurrence in rectovaginal fistula repair with or without Martius flap

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tamer Alsaied Alnaimy

assistant professour

Zagazig University

研究点 (2)

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