STOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy With Ileorectal Anastomosis Versus Subtotal Colectomy With Cecal-rectal Anastomosis for Slow Transit Constipation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 14
- 主要终点
- Wexner Constipation Score
研究概览
简要总结
Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.
详细描述
Constipation, a prevalent gastrointestinal disorder, affects 10%-15% of adults in the United States and approximately 8.2% of China's general population. Slow transit constipation (STC), accounting for 15%-42% of constipation cases, is characterized by impaired colonic motility. For patients refractory to conservative therapies who experience chronic, intractable symptoms and diminished quality of life (QoL), surgical intervention becomes the last-resort treatment. The primary surgical approach for STC has historically been total colectomy with ileorectal anastomosis (TC-IRA). Over the past two decades, however, subtotal colectomy with cecorectal anastomosis (SC-CRA) has garnered growing interest within the surgical community due to its potential to mitigate postoperative diarrhea. Despite this benefit, SC-CRA raises concerns about an elevated risk of recurrent constipation. The debate regarding the superiority of these approaches remains unresolved. This study aims to address this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (≥18 years of age) of either sex
- •Patients with conditions in agreement with the Roman IV criteria of functional constipation
- •Patients have less than one complete spontaneous bowel movement per week
- •Patients rely on laxatives to assist defecation for a long time
- •More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
- •Patients were refractory to conservative treatment for more than 1 year
- •Patients with a strong desire for surgery
排除标准
- •Pregnant or breast-feeding women
- •Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
- •Patients with colorectal neoplasms
- •Patients with small intestinal slow transit
- •Patients with constipation-predominant irritable bowel syndrome
- •Patients with inflammatory bowel disease
- •Patients with ileostomy
- •Patients with severe psychiatric disease
研究组 & 干预措施
Total colectomy with ileorectal anastomosis
Total colectomy with ileorectal anastomosis (TC-IRA) serves as the standard surgical treatment for slow transit constipation.
干预措施: Total colectomy with ileorectal anastomosis (Procedure)
Subtotal colectomy with cecal-rectal anastomosis
Subtotal colectomy with cecorectal anastomosis (SC-CRA) is selectively employed for slow transit constipation.
干预措施: Subtotal colectomy with cecal-rectal anastomosis (Procedure)
结局指标
主要结局
Wexner Constipation Score
时间窗: From the pre-operation to 36 months following surgery
The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)
次要结局
- Gastrointestinal Quality of Life Index(From the pre-operation to 36 months following surgery)
- 36-item short-form health survey(From the pre-operation to 36 months following surgery)
- The incidence of complications(From the pre-operation to 36 months following surgery)
- The number of bowel movements per week(From the pre-operation to 36 months following surgery)
- Wexner's incontinence score(From the pre-operation to 36 months following surgery)
- The incidence of abdominal pain(From the pre-operation to 36 months following surgery)
- The incidence of bloating(From the pre-operation to 36 months following surgery)
- The incidence of diarrhea(From the pre-operation to 36 months following surgery)
- The incidence of straining(From the pre-operation to 36 months following surgery)
- The incidence of laxative use(From the pre-operation to 36 months following surgery)
- The incidence of enema use(From the pre-operation to 36 months following surgery)
- Intraoperative measures(Perioperative period)
研究者
Weidong Tong
Director
Third Military Medical University