Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Postoperative Complications
研究概览
简要总结
The objective of this RCT is to compare the postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.
详细描述
Theoritically, the advantge of TAMIS surgery over traditional trans-abdominal IPAA surgery incudes shorter operation time due to simulatous surgery transanlly and transabdominally, reduced operative difficulty in narrow male pelvis, less retained rectal cuff and less "dog-ear" formation. However, its adgange has not been proven in prospecitve randomized trials. The aim of current study is to compare the short and long-term postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.
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
- 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
- 否
入选标准
- •Clincially and pathologically proven ulcerative colitis
- •Aged 18-75 years
- •Patients who will undergo proctectomy and IPAA surgery, incuding the first stage of two-stage surgery, or the second stage of three-stage or modified two-stage surgery
- •Elective surgery
- •Informed constent obtained.
排除标准
- •A contraindication for minimally invasive surgery or TAMIS surgery
- •Ileus or peritonitis
- •Previous surgery in rectum
- •Pregnancy
- •Carcinogenesis of rectum, dysplasia or stricture of ATZ, or planned mucosectomy
- •Patients with planned permnant ileostomy
结局指标
主要结局
Postoperative Complications
时间窗: Day 30
Postoperative complcations were documented using comprehensive complication index(CCI)
次要结局
- Postoperative quality of life(up to 1 year)
- Intraoperative complications(24 Hr)
- Time to GI-2 recovery(Day 90)
- The incidence of cuffitis and pouchitis(up to 1 year)
- The incidence of pouch extension(24 Hr)
- Postoperative anastmotic leakage(Day 90)
- Overall cost of treatment(up to 1 year)
- Remaining length of anal mucosa.(24 Hr)
- Estimated blood loss(24 Hr)
- Postoperative length of hospital stay(Day 90)
- Duration of operation(24 Hr)
研究者
Jianfeng Gong
associate professor
Jinling Hospital, China