Image

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

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

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

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.

Description

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.

Eligibility

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.

Study details
    Defecation Function
    Quality of Life

NCT04304183

Third Military Medical University

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.