Clinical trial NCT03909204: LAPEC for the Treatment of Severe Constipation
Official title: Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC) in Adults for the Treatment of Severe Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cecostomy; Complications
Constipation
Keywords: Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
Lead sponsor: University Hospital Trnava
Sponsor class: NETWORK
First posted: 2019-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change in Bowel QoL
timeFrame: Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement
Secondary outcomes:
measure: Change in Bowel QoL
timeFrame: 3 months, 6 months, 12 months, 24 months
measure: Removal rate
timeFrame: 12 months
measure: Transit time
timeFrame: At 3 and 12 month after PEC placement
measure: Frequency and Severity of Abdominal Pain
timeFrame: Data collection will start following consent and procedural training and will be collected daily from day 1 for the duration of the study, an expected average of 12 weeks
measure: Flush Administration Time
timeFrame: Data collection will start with the first flush administered following discharge from the hospital and will be collected with every subsequent flush through completion of the study, an expected average of 48 weeks
measure: Flush volume
timeFrame: Data collection will start with the first flush administered following discharge from the hospital and will be collected with every subsequent flush through completion of the study, an expected average of 48 weeks
measure: Procedural adverse event
timeFrame: 1 month
measure: Long-term adverse events
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Trnava
country: Slovakia
facility: Rastislav Hustak
Study officials:
affiliation: Surgeon
name: Radovan Skuta
role: PRINCIPAL_INVESTIGATOR
References: