Evaluating defecation function and quality of life after surgery for slow transit constipation

Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation

This study is testing whether surgery can help people with slow transit constipation have better bowel movements and improve their quality of life over five years.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 1 site (Yuzhong, Chongqing)
• Trial ID: NCT04304183 on ClinicalTrials.gov

What this trial studies

This observational study investigates the effectiveness of total or subtotal colectomy in improving defecation function and quality of life for patients suffering from slow transit constipation (STC). It aims to follow patients for five years to assess both short- and long-term outcomes after surgical intervention. The study addresses a significant gap in the literature regarding the long-term effects of surgical treatments for STC, which affects a notable percentage of the population. By focusing on patients who have not responded to conservative treatments, the study seeks to provide valuable insights into surgical efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with functional constipation who have severe symptoms and have not responded to conservative treatments for over a year.

Not a fit: Patients with megacolon, intestinal organic lesions, or those with mental health issues such as depression or anxiety may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and enhanced quality of life for patients with severe slow transit constipation.

How similar studies have performed: While surgical interventions for STC have been performed historically, this study aims to provide new insights into long-term outcomes, making it a novel approach in this area.

Eligibility criteria

Inclusion Criteria:

1. The clinical manifestations all met the Roman IV standard for the diagnosis of functional constipation.
2. Patients with severe constipation symptoms were unable to defecate naturally and need laxatives to assist defecation or still unable to defecate.
3. Colonic transport tests showed that the opaque X-ray markers remained more than 20% after 72 hours.
4. All conservative treatment for more than 1 year failed.
5. Patients had a strong desire for surgery, and no other contraindications to surgery.

Exclusion Criteria:

1. Megacolon was detected with barium enema examination.
2. Colonoscopy suggested the presence of intestinal organic lesions or a history of colorectal cancer treatment.
3. Gastric and small intestinal transport dysfunction.
4. There are depression, anxiety and other mental symptoms.
5. Constipation type irritable bowel syndrome.
6. History of inflammatory bowel disease.

Where this trial is running

Yuzhong, Chongqing

• Weidong Tong — Yuzhong, Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Yue Tian, MD

Conditions Defecation Function; Quality of Life; Slow transit constipation; Defecation function; Quality of life