LAPEC for the Treatment of Severe Constipation

Study Overview
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Brief Summary
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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.

Official Title
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Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC) in Adults for the Treatment of Severe Constipation

Conditions
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Cecostomy; Complications, Constipation

Intervention / Treatment
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* Procedure: LAPEC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LAPEC<br>Patients with cecal percutaneous catheter placement. | Procedure: LAPEC<br>* 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.<br>* Other names: Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bowel QoL | Main outcome is the proportion of patients with treatment success at 3 and 6 months after the catheter placement. Treatment success is defined as a decrease of Quality of Life symptoms score at least 50% to a baseline values. To assess constipation severity the Knowles Eccersley Scott Symptom (KESS) before and throughout the study will be completed. The KESS is an 11-item tool for diagnosis of constipation. The KESS uses four- to five-point Likert scales that are scored on an unweighted linear integer scale. Total scores can range from 0 (no symptoms) to 39 (high symptom severity). | Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bowel QoL | Evolution of Quality of Life questionnaire before and after PEC placement at 3, 6, 12 and 24 months. To assess constipation severity the Knowles Eccersley Scott Symptom (KESS) before and throughout the study will be completed. The KESS is an 11-item tool for diagnosis of constipation. The KESS uses four- to five-point Likert scales that are scored on an unweighted linear integer scale. Total scores can range from 0 (no symptoms) to 39 (high symptom severity). | 3 months, 6 months, 12 months, 24 months | 
| Removal rate | Proportion of patients with PEC in use and removed. | 12 months | 
| Transit time | Change in x-ray transit time | At 3 and 12 month after PEC placement | 
| Frequency and Severity of Abdominal Pain | Frequency and severity of abdominal pain will be recorded daily and measured using the Visual analog pain scale as the appropriate visual analog scale. Score is based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-points line that represents a continuum between the two ends of the scale-no pain on the left end (0) of the scale and the worst pain on the right end of the scale (10). | 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 | 
| Flush Administration Time | Administration time in minutes per flush will be defined as the time at which the tubing connected to the bag or syringe and the cecostomy fluid starts to infuse into the patient to the time the infusion is completed. | 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 | 
| Flush volume | Volume will be measured and recorded by the patient with each flush and calculated by the investigator in mL/kg using the weight obtained at the clinic visit preceding each effectiveness phase change. | 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 | 
| Procedural adverse event | Perioperative adverse events (complications) | 1 month | 
| Long-term adverse events | Incidence rate of adverse events during follow-up | 3, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy