LAPEC Procedure for Severe Constipation in Adults
LAPEC
Constipation+1
+ Signs and Symptoms
+ Signs and Symptoms, Digestive
Treatment Study
Summary
Study start date: May 20, 2019
Actual date on which the first participant was enrolled.Severe constipation can be a tough health issue to manage, especially when diet changes and medications like laxatives don't provide enough relief. In such cases, doctors might consider surgical options. One such procedure is the Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC), which is a less invasive method that allows patients to administer osmotic agents directly to the right colon. While LAPEC has shown promise in young adults and children, there's limited data on its effectiveness and safety in adults. This study aims to fill this gap by evaluating the short and long-term benefits and risks of LAPEC in adults with severe constipation. In this study, participants will undergo the LAPEC procedure, which involves the placement of a catheter. The primary goal is to measure the improvement in quality of life related to bowel movements. This will be assessed using a questionnaire called the Knowles Eccersley Scott Symptom (KESS) score, which helps diagnose constipation and measure its severity. A successful treatment is defined as a decrease of at least 50% in the KESS score compared to the baseline, at 3 and 6 months after the catheter placement.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location