Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postoperative complication
研究概览
简要总结
This is a prospective interventional study on the treatment of transsphincteric fistula in ano. After abdominal or thigh liposuction, fat was injected around the fistula tract that was then transected percutaneously with a sharp cannula and fat injected between and around the cut parts. The internal opening was closed with a suture. Minimum follow up of 12 months is planed
详细描述
The study is intended to be carried out at the Department of Surgery of Uppsala University Hospital, as a single-center study. All (consecutive) otherwise healthy patients between the ages of 18-70 who have been diagnosed with perianal fistula where attempts to close the fistula is considered appropriate are asked to participate. This is done by the examining physician at their visit at the outpatient clinic. These are either patients who already have a relieving seton or those who need to be revised and treated with a seton before final closure.
They receive written information about the study plan and have time to think about it. If they choose to participate in the study, they are planed for a visit to one of the surgeons involved in the study and here get another opportunity to ask questions and then also sign an informed consent. This step can be adjusted as telephone contact due to the Covid-19 pandemic. Thereafter, they are included in the study.
The participants are operated on only by the surgeons involved, all of whom have undergone practical training in how fat cell transplantation is carried out according to the standardized Coleman method.
The procedure itself then takes place as a day surgery operation at the Samariter Hemmet ( part of the Surgical Department, Uppsala University Hospital ) operating department and either as a one- or two-step procedure, depending on whether they have a relieving seton or not. The seton has to be placed sometime before the definitive fatty tissue procedure so that there is no sign of inflammation/infection.
A 3- and 12-months follow up visit is then arranged. In these visits, the patients are examined for evaluation of the result, possible residual fistulas, and complications. Wexner score and VAS scale are filed in and saved in their patient files.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Verified perianal or rectovaginal fistula
- •Healthy individuals that can be accepted for an elective operation with total anesthesia.
- •Signed consent
排除标准
- •Patients under the age of 18 or over the age of 75 years
- •Another disease that can affect the perianal are or the procedure
- •Patients that are not able to understand and sign the consent themselves.
结局指标
主要结局
Postoperative complication
时间窗: 12 months after index operation
Possible complications linked to index operation
Clinical healing of fistula in ano
时间窗: 12 months after index operation
No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic
次要结局
- Injected fat quantity(During index operation)
- Visual Analog Pain Scale score(12 months after index operation)
- Functional effects(12 months after index operation)
研究者
Konstantinos Tsimogiannis
Consultant
Uppsala University Hospital