Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of straining
研究概览
简要总结
Although surgical options for slow transit constipation (STC) have been proven to be a definite treatment, improvements in the associated defecation function and quality of life are rarely studied. This study aims to investigate the effectiveness of total or subtotal colectomy, with respect to short- and long-term defecation function and overall quality of life in 5-year regular follow-up.
详细描述
Constipation is an ever-growing problem and one of the most common gastrointestinal symptoms, affecting 10-15% of adults in the USA and 8.2% of the general population in China. Slow-transit constipation, representing 15~30% constipated patients, is characterized by a loss in the colonic motor activity. Factors such as increasing age, female sex, physical inactivity, endocrine, metabolism, neurological factors, drug use, and depression are associated with constipation. While most patients with constipation are mild and treated easily by a behavioral and medical way, a minority of patients suffering from long-term intractable symptoms and poor quality of life and showing no response to any medical interventions are ultimately recommended for surgery.
Since the effectiveness of colectomy for constipation was first reported by Lane a century ago, surgical treatment for constipation has been greatly developed[6], including ileorectal anastomosis (IRA), cecorectal anastomosis(CRA), colonic exclusion, antegrade enemas (the Malone procedure), modified Duhamel surgery, and permanent ileostomy. Currently, the main surgical procedures for STC are IRA and CRA, which have been widely confirmed to increase bowel-movement frequency in a huge number of patients. However, the reported outcomes of colectomy are controversial and conflicting.In these studies, lack of prospectively defined follow-up intervals is a general problem. Moreover, long-term outcomes of surgery for STC are rarely reported. Furthermore, negatively persistent symptoms including abdominal pain, bloating, intractable diarrhea, malnutrition, constipation recurrence, fecal incontinence, and intestinal obstruction are not uncommon following surgery, adversely affecting defecation function and quality of life following these procedures.
This study aims to investigate the effectiveness of total or subtotal colectomy, with respect to short- and long-term defecation function and overall quality of life during 5-year regular follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The clinical manifestations all met the Roman IV standard for the diagnosis of functional constipation.
- •Patients with severe constipation symptoms were unable to defecate naturally and need laxatives to assist defecation or still unable to defecate.
- •Colonic transport tests showed that the opaque X-ray markers remained more than 20% after 72 hours.
- •All conservative treatment for more than 1 year failed.
- •Patients had a strong desire for surgery, and no other contraindications to surgery.
排除标准
- •Megacolon was detected with barium enema examination.
- •Colonoscopy suggested the presence of intestinal organic lesions or a history of colorectal cancer treatment.
- •Gastric and small intestinal transport dysfunction.
- •There are depression, anxiety and other mental symptoms.
- •Constipation type irritable bowel syndrome.
- •History of inflammatory bowel disease.
结局指标
主要结局
The incidence of straining
时间窗: from the pre-operation to the five years following surgery
the incidence of straining will be recorded in terms of percent.
The incidence of laxative
时间窗: from the pre-operation to the five years following surgery
the incidence of laxative will be recorded in terms of percent.
The scales of Gastrointestinal Quality of Life Index
时间窗: from the pre-operation to the five years following surgery
the scales of Gastrointestinal Quality of Life Index will be recorded in terms of scores.
The number of bowel movements
时间窗: from the pre-operation to the five years following surgery
the number of bowel movements will be recorded in terms of times per week.
The scales of Wexner Constipation
时间窗: from the pre-operation to the five years following surgery
the scales of Wexner Constipation will be recorded in terms of scores.
The incidence of bloating
时间窗: from the pre-operation to the five years following surgery
the incidence of bloating will be recorded in terms of percent.
The scales of Wexner Incontinence
时间窗: from the pre-operation to the five years following surgery
the scales of Wexner Incontinence will be recorded in terms of scores.
The incidence of abdominal pain
时间窗: from the pre-operation to the five years following surgery
the incidence of abdominal pain will be recorded in terms of percent.
The incidence of diarrhea
时间窗: from the pre-operation to the five years following surgery
the incidence of diarrhea will be recorded in terms of percent.
The incidence of enema use
时间窗: from the pre-operation to the five years following surgery
the incidence of enema use will be recorded in terms of percent.
The short-form(SF)-36 survey
时间窗: from the pre-operation to the five years following surgery
There are eight spheres in the SF-36 survey, including physical function, role physical, role emotional, physical pain, vitality, mental health, social function and general health. Results of each sphere will be recorded in terms of scores.
次要结局
- Number of Participants with complications(from the pre-operation to the five years following surgery)
研究者
Weidong Tong
Professor
Third Military Medical University