LAPEC for the Treatment of Severe Constipation

University Hospital Trnava

Status

Enrolling

Conditions

Cecostomy; Complications

Constipation

Treatments

Procedure: LAPEC

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT03909204

LAPEC for obstipation

Details and patient eligibility

About

Effective treatment for constipation is a real clinical challenge especially in patients with severe symptoms. Dietary measures (bulking agents) and drugs (laxatives, stool softeners, suppositories and enemas etc.) have limited efficacy in severe cases. If conservative measures do not help, surgical therapies might be considered. Subsequently, antegrade enemas through percutaneous colonic catheter were introduced as a less invasive option for treating severe constipation. The cecostomy has been performed laparoscopically, percutaneously, and with the laparoscopic-assisted percutaneous endoscopic cecostomy (LAPEC) technique. This approach allows patients to deliver osmotic agents to the right colon.The procedure has been demonstrated to be safe and effective in young adults and pediatrics. To date, there are only few studies evaluating the safety and efficacy of the LAPEC procedure in adults and all have retrospective profile. The aim of this prospective study is to compare short and long-term efficacy and safety of LAPEC in patients with severe constipation. Symptoms of defecation will be the main outcome criteria.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)
Hirschsprung's disease
Idiopathic constipation ineffective to standard treatment
Cauda equine syndrome
Combination of spina bifida and tethered cord
Colonic neuropathy.
Persons 18 years or older at the time of signing the informed consent
Signed informed consent

Exclusion criteria

Non-LAPEC cecostomy procedure
Pre-existing severe electrolyte imbalance
Chronic high rectal tone
Advanced liver cirrhosis (Child B or Child C)
Pregnancy or puerperium
Advanced colorectal cancer
Presence of ventriculoperitoneal shunt
Colonic disease or surgery that might impact safety of percutaneous colostomy tube placement (right hemicolectomy, IC resection, previous apendicostomy) and confirmed inflammatory bowel disease
Any other condition, which in the opinion of the investigator would interfere with study requirements