LAPEC for the Treatment of Severe Constipation

Last updated: October 26, 2022
Sponsor: University Hospital Trnava
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Treatment

N/A

Clinical Study ID

NCT03909204
LAPEC for obstipation
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Refractory (> 6 months) and severe (based on a =KESS >11) and non-invasive therapeuticapproaches, including an enhanced fiber diet, lifestyle changes, laxatives, andbiofeedback 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

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 tubeplacement (right hemicolectomy, IC resection, previous apendicostomy) and confirmedinflammatory bowel disease
  • Any other condition, which in the opinion of the investigator would interfere withstudy requirements

Study Design

Total Participants: 30
Study Start date:
May 20, 2019
Estimated Completion Date:
May 12, 2023

Connect with a study center

  • Rastislav Hustak

    Trnava, 917 75
    Slovakia

    Active - Recruiting

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