Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Wound healing time
研究概览
简要总结
This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.
详细描述
This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. There will be an inclussion visit in which personal information will be recorded and the consent will be signed. Randomization will be done after inclusion, following a balanced blocks model. Information of the surgery technic won't be available for the investigator. The patients will have a journal in which they'll write their postoperative symptoms. Follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. Data will be based in clinical examination, patient's diary and medical records. Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test, or in case needed, a multivariate Cox regression analysis. The secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
- •Ability to understand the study, to sign the consent and to complete the follow-up.
排除标准
- •Under 18 years of age.
- •Complex/recurrent fistula.
- •Patients in which by clinical criteria is decided not to perform a fistulotomy.
- •Anorectal malignancy.
- •Crohn's desease.
- •ASA IV or other contraindication for surgery.
- •Inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.
结局指标
主要结局
Wound healing time
时间窗: 6 weeks
Comparisson of the time it takes for the wound to not have areas without epithelium after the fistulotomy between the group with marsupialization and the open wound group.
次要结局
- Hospitalization time(2 days)
- Return to daily activities(6 weeks)
- Operating time(60 minutes)
- Who performs the dressing change(6 weeks)
- Postoperative pain(6 weeks)
- Bleeding of the postoperative wound(6 weeks)
- Anal incontinence(6 weeks)
- Frequency of dressing change(6 weeks)
- Postoperative wound infection(6 weeks)
- Recurrence of the fistula(1 year)