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LAPEC for the Treatment of Severe Constipation

NCT03909204 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-27

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

LAPEC

Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy: Initially, one to tree-laparoscopy port technique will be used, with hand placement of seroperitoneal sutures for cecal fixation. After than during colonoscopy a cecal position will be visualized and colonic lumen will be insuflated. After than the PEC tube will be introduced into the cecum using the dilators and sheath. Intravenous antibiotics will be given prior to the procedure and will continued parental temporary and later orally after catheter insertion. One weeks later, antegrade colonic enema will start during an out-patient visit including an educational training of the patient to the catheter manipulation. Antegrade enema solution will start at dose of 2ml/kg and will be increased up to 20ml/kg or a maximum dose of 2000 mL daily. Adjuvant of colonic motility stimulants are allowed during follow-up.

Sponsors & Collaborators

  • University Hospital Trnava

    lead NETWORK

Principal Investigators

  • Radovan Skuta · Surgeon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2023-05-01
Completion
2023-05-12

Countries

  • Slovakia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909204 on ClinicalTrials.gov