Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated Complex Perianal Fistula
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Healing rate
研究概览
简要总结
The goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery.
The main question it aims to answer is:
- Does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery?
Researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time.
Quality of life and global morbidity will also be analyzed.
Participants will:
- Undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique.
- Attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than
- •Present with a complex perianal fistula not surgically treated with curative intention.
- •Present only one main fistulous tract.
- •Mucosal advancement flap as the chosen technique for the treatment of the fistula.
- •Patient has given informed consent to participate in the study.
排除标准
- •Non-cryptoglandular internal fistulous orifice (IFO).
- •Extrasphincteric fistula.
- •Coexistence of anal fissure.
- •Coexistence of hemorrhoids tributary to surgery.
- •Coexistence of anal or rectal prolapse.
- •Coexistence of inflammatory bowel disease.
- •Coexistence of anal or colorrectal cancer.
研究组 & 干预措施
Minimally Invasive Approach In The Mucosal Advancement Flap Technique
干预措施: Minimally Invasive Approach In The Mucosal Advancement Flap Technique (Procedure)
结局指标
主要结局
Healing rate
时间窗: six months
Healing will be measured if 4 criteria are present: no supuration or pain for more than a week, no open external fistulous orifice, no palpable trajectory, no internal fistulous orifice and no tract or collections in 3D endoanal ultrasound.
次要结局
- Postoperative pain(one week)
- Quality of life score(six months)
- Global morbidity(one month)
- Fecal incontinence(six months)
研究者
Ignacio Fernandez Hurtado
Specialist in General Surgery. Specialist in Digestive Surgery
Hospital Son Llatzer