TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 780
- 主要终点
- the recurrence rate of the severe prolapsed Hemorrhoids after surgery
研究概览
简要总结
TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe prolapsed hemorrhoids
- •no significant anal-malformation before operation
- •having signed the informed consent.
排除标准
- •needing emergency operation or having previous history of hemorrhoids operation
- •with other anal diseases at the same time such as : anal fissure, anal fistula and perianal abscess and so on
- •diagnosed with inflammatory bowel disease or proctitis
- •diagnosed with colorectal cancer
- •associated with cardiovascular and cerebrovascular diseases and other diseases so that can not tolerate surgery or increase the risk of surgery
- •with chronic or acute renal insufficiency patients
- •coagulation abnormalities or with anticoagulation treatment at present
- •diagnosed with diabetes with poor glycemic control
- •in women with pregnant or menstruation
- •The intellectual disabilities or mental disorder
- •had participated in other clinical trial before we selected 4 weeks
- •other severe complications.
研究组 & 干预措施
group A( TSTstarr+ group)
TSTstarr+ is a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler, " +" means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation .
干预措施: TSTstarr+ (Procedure)
group B ( PPH group)
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
干预措施: PPH (Procedure)
结局指标
主要结局
the recurrence rate of the severe prolapsed Hemorrhoids after surgery
时间窗: 2 years
780 patients will be enrolled in one year.All patients will be followed up for one year, and then calculate 1 year recurrence rate between TSTstarr+ group and PPH group
次要结局
- Operation time(1 year)
- Intraoperative hemorrhage(1 year)
- The number of patients with stricture of anus after surgery(2 years)
- The number of patients with retention of urine in the early time after surgery(2 years)
- The time of returning to normal(2 years)
- The volume of specimens(1year)
- The number of patients with anal pain after surgery(2 years)
- The number of patients with hemorrhage after surgery(2 years)
- The number of patients with edema of the anal margin in the early time after surgery(2 years)
- The total cost of hospitalization(2 years)
- The weight of specimens(1year)
- The number of patients with fecal urgency after surgery(2 years)