STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
- Conditions
- SurgerySlow Transit Constipation
- Interventions
- Procedure: total colectomy with ileorectal anastomosisProcedure: subtotal colectomy with cecal-rectal anastomosis
- Registration Number
- NCT05352074
- Lead Sponsor
- Third Military Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 252
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description total colectomy with ileorectal anastomosis total colectomy with ileorectal anastomosis After a complete mobilization of the colon, a resection 2-3 cm proximal to the ileocecal junction is conducted. Use a Pfannestiel incision to perform the anastomosis and to remove the resected colon. The ileorectal anastomosis is performed by introducing the stapler via the anus, with the intention of carrying out a ''cleaner,'' ''tensionless'' procedure. subtotal colectomy with cecal-rectal anastomosis subtotal colectomy with cecal-rectal anastomosis After a complete mobilization of the colon, a resection 2-3cm distal to the ileocecal junction and at the upper part of the rectal ampulla are conducted; the cecum is then lowered into the pelvis, without any rotation, and an antiperistaltic cecorectal anastomosis is performed between the cecal fundus (after appendectomy) and the rectum, after introduction of a stapler through the cecal resection line. Use a Pfannestiel incision to perform the anastomosis and to remove the resected colon. The cecal-rectal anastomosis is performed by introducing the stapler via the anus, with the intention of carrying out a ''cleaner,'' ''tensionless'' procedure.
- Primary Outcome Measures
Name Time Method Wexner Constipation Score 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)
- Secondary Outcome Measures
Name Time Method Gastrointestinal Quality of Life Index From the pre-operation to 36 months following surgery Gastrointestinal Quality of Life Index will be recorded in terms of scores. There are The four possible answers to every question, scored from 0 points (worst) to 4 points (best). The final sum ranges from 0(worst) to 144(best).
36-item short-form health survey From the pre-operation to 36 months 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. Once the questionnaire was applied to the patients, a summary calculation and a linear transformation were performed to obtain a score within a scale from 0(worst) to 100(best).
The incidence of complications From the pre-operation to 36 months following surgery Postoperative complications includes short-term and long-term complications, such as ileus, anastomotic leak, small intestinal obstruction, constipation recurrence and so on. Number of Participants with complications will be recorded.
The number of bowel movements per week From the pre-operation to 36 months following surgery The number of bowel movements will be recorded in terms of times per week.
Wexner's incontinence score From the pre-operation to 36 months following surgery The Wexner's incontinence score will be recorded in terms of scores. the sacles have 5 items to quantify incontinence grade and frequency and its effect on ordinary life. Each question is answered on a scale of 0 to 4, the global score ranging from 0 (best) to 20 (worst).
The incidence of abdominal pain From the pre-operation to 36 months following surgery The incidence of abdominal pain will be recorded in terms of percent. no special measurement is needed.
The incidence of bloating From the pre-operation to 36 months following surgery The incidence of bloating will be recorded in terms of percent
The incidence of diarrhea From the pre-operation to 36 months following surgery The incidence of diarrhea will be recorded in terms of percent.
The incidence of straining From the pre-operation to 36 months following surgery The incidence of straining will be recorded in terms of percent.
The incidence of laxative use From the pre-operation to 36 months following surgery The incidence of laxative use will be recorded in terms of percent.
The incidence of enema use From the pre-operation to 36 months following surgery The incidence of enema use use will be recorded in terms of percent.
Intraoperative measures Perioperative period Operation time (minutes), blood loss (mL), complications (classified according to Clavien-Dindo) for both study groups.
Trial Locations
- Locations (16)
Army Medical Center (Daping Hospital)
🇨🇳Yuzhong, Chongqing, China
No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
🇨🇳Lanzhou, Gansu, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
General Hospital of the Eastern Theater Cammand of the PLA
🇨🇳Nanjing, Jiangsu, China
The First Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Renji Hospital, Shanghai Jiaotong University
🇨🇳Pudong, Shanghai, China
Shanghai Pudong New Area People's Hospital
🇨🇳Pudong, Shanghai, China
Xijing Hospital
🇨🇳Xi'an, Shanxi, China
Chengdu Analrectal Hospital
🇨🇳Chengdu, Sichuan, China
The General Hospital of Western Theater Command
🇨🇳Chengdu, Sichuan, China
The Second People's Hospital of Yibin
🇨🇳Yibin, Sichuan, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China