Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-05-20
2023-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LAPEC
Patients with cecal percutaneous catheter placement.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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University Hospital Trnava
NETWORK
Responsible Party
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Principal Investigators
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Radovan Skuta
Role: PRINCIPAL_INVESTIGATOR
Surgeon
Locations
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Rastislav Hustak
Trnava, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LAPEC for obstipation
Identifier Type: -
Identifier Source: org_study_id
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