Back to resultsLAPEC for the Treatment of Severe Constipation
Primary Purpose
Cecostomy; Complications, Constipation
Status
Recruiting
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
LAPEC
Sponsored by
About this trial
This is an interventional treatment trial for Cecostomy; Complications focused on measuring Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
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
Sites / Locations
- Rastislav HustakRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LAPEC
Arm Description
Patients with cecal percutaneous catheter placement.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Removal rate
Proportion of patients with PEC in use and removed.
Transit time
Change in x-ray transit time
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).
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.
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.
Procedural adverse event
Perioperative adverse events (complications)
Long-term adverse events
Incidence rate of adverse events during follow-up
Full Information
NCT ID
NCT03909204
First Posted
April 5, 2019
Last Updated
October 26, 2022
Sponsor
University Hospital Trnava
1. Study Identification
Unique Protocol Identification Number
NCT03909204
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Trnava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cecostomy; Complications, Constipation
Keywords
Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Supportive Care
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAPEC
Arm Type
Other
Arm Description
Patients with cecal percutaneous catheter placement.
Intervention Type
Procedure
Intervention Name(s)
LAPEC
Other Intervention Name(s)
Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Bowel QoL
Description
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).
Time Frame
Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement
Secondary Outcome Measure Information:
Title
Change in Bowel QoL
Description
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).
Time Frame
3 months, 6 months, 12 months, 24 months
Title
Removal rate
Description
Proportion of patients with PEC in use and removed.
Time Frame
12 months
Title
Transit time
Description
Change in x-ray transit time
Time Frame
At 3 and 12 month after PEC placement
Title
Frequency and Severity of Abdominal Pain
Description
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).
Time Frame
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
Title
Flush Administration Time
Description
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.
Time Frame
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
Title
Flush volume
Description
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.
Time Frame
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
Title
Procedural adverse event
Description
Perioperative adverse events (complications)
Time Frame
1 month
Title
Long-term adverse events
Description
Incidence rate of adverse events during follow-up
Time Frame
3, 6, 12, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rastislav Hustak
Phone
00421918905728
Email
rhustak@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Radovan Skuta
Email
radovan_skuta@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radovan Skuta
Organizational Affiliation
Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rastislav Hustak
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rastislav Hustak
Email
rhustak@gmail.com
First Name & Middle Initial & Last Name & Degree
Radovan Skuta
Email
radovan_skuta@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
LAPEC for the Treatment of Severe Constipation
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