Comparing total and subtotal colectomy for slow transit constipation

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

This study is testing two types of surgery for people with slow transit constipation who haven't found relief from other treatments to see which one helps them feel better and live more comfortably.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 16 sites (Yuzhong, Chongqing and 15 other locations)
• Trial ID: NCT05352074 on ClinicalTrials.gov

What this trial studies

This study compares two surgical approaches for treating slow transit constipation (STC) in patients who have not responded to conservative treatments. It evaluates the efficacy and safety of total colectomy with ileorectal anastomosis versus subtotal colectomy with cecorectal anastomosis. The research aims to clarify which surgical option provides better outcomes in terms of defecation function and quality of life. By analyzing patient responses and postoperative results, the study seeks to resolve ongoing debates in surgical practice regarding the best treatment for STC.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with slow transit constipation who have not found relief through conservative treatments for over a year.

Not a fit: Patients with conditions such as megacolon, severe spastic constipation, or inflammatory bowel disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical options for patients suffering from chronic constipation, enhancing their quality of life.

How similar studies have performed: While there has been growing interest in subtotal colectomy as an alternative, the comparative effectiveness of these two approaches remains largely untested in a structured trial setting.

Eligibility criteria

Inclusion criteria

1. Patients (≥18 years of age) of either sex
2. Patients with conditions in agreement with the Roman IV criteria of functional constipation
3. Patients have less than one complete spontaneous bowel movement per week
4. Patients rely on laxatives to assist defecation for a long time
5. More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
6. Patients were refractory to conservative treatment for more than 1 year
7. Patients with a strong desire for surgery

Exclusion criteria

1. Pregnant or breast-feeding women
2. Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
3. Patients with colorectal neoplasms
4. Patients with small intestinal slow transit
5. Patients with constipation-predominant irritable bowel syndrome
6. Patients with inflammatory bowel disease
7. Patients with ileostomy
8. Patients with severe psychiatric disease

Where this trial is running

Yuzhong, Chongqing and 15 other locations

• Army Medical Center (Daping Hospital) — Yuzhong, Chongqing, China (Recruiting)
• No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army — Lanzhou, Gansu, China (Recruiting)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Withdrawn)
• The First Affiliated Hospital of Harbin Medical University — Ha'erbin, Heilongjiang, China (Withdrawn)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• General Hospital of the Eastern Theater Cammand of the PLA — Nanjing, Jiangsu, China (Recruiting)
• The First Hospital of China Medical University — Shengyang, Liaoning, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Recruiting)
• Renji Hospital, Shanghai Jiaotong University — Pudong, Shanghai, China (Recruiting)
• Shanghai Pudong New Area People's Hospital — Pudong, Shanghai, China (Recruiting)
• Xijing Hospital — Xi'an, Shanxi, China (Recruiting)
• Chengdu Analrectal Hospital — Chengdu, Sichuan, China (Recruiting)
• The General Hospital of Western Theater Command — Chengdu, Sichuan, China (Recruiting)
• The Second People's Hospital of Yibin — Yibin, Sichuan, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Man Guo, MS

Conditions Slow Transit Constipation; Surgery; Total Colectomy with Ileorectal Anastomosis; Subtotal Colectomy with Caecorectal Anastomosis; Defecation Function; Quality of Life; Randomized Controlled Trial