Suspended

LAPEC Procedure for Severe Constipation in Adults

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What is being tested

LAPEC

Procedure
Who is being recruted

Constipation+1

+ Signs and Symptoms

+ Signs and Symptoms, Digestive

From 18 to 85 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2019
See protocol details

Summary

Principal SponsorUniversity Hospital Trnava
Study ContactRastislav HustakMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleLaparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC) in Adults for the Treatment of Severe Constipation
NCT03909204
Principal SponsorUniversity Hospital Trnava
Study ContactRastislav HustakMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

ConstipationSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms

Criteria

11 inclusion criteria required to participate
Refractory (> 6 months) and severe (based on a =KESS >11) and non-invasive therapeutic approaches, including an enhanced fiber diet, lifestyle changes, laxatives, and biofeedback failed.

Slow transit constipation

Anorectal malformation

Mixed constipation (combination of outlet obstruction and slow transit)

Show More Criteria

9 exclusion criteria prevent from participating
Non-LAPEC cecostomy procedure

Pre-existing severe electrolyte imbalance

Chronic high rectal tone

Advanced liver cirrhosis (Child B or Child C)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Patients with cecal percutaneous catheter placement.

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

Recruiting

Rastislav Hustak

Trnava, SlovakiaOpen Rastislav Hustak in Google Maps
SuspendedOne Study Center