Cecostomy; ComplicationsNCT03909204
LAPEC for the Treatment of Severe Constipation
A study testing LAPEC in people with Cecostomy; Complications and Constipation, run by University Hospital Trnava at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cecostomy; Complications, Constipation
- What is being tested?
- LAPEC
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovakia
- Study dates
- 20 May 2019to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Radovan Skuta contact
Slovakia1 site, 1 recruiting
- Recruiting
Rastislav Hustak
Trnava, 917 75
Rastislav Hustak, rhustak@gmail.com
Radovan Skuta, radovan_skuta@yahoo.com
About this study
Official title: Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC) in Adults for the Treatment of Severe Constipation
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
- Cecostomy; Complications, Constipation
- Being tested
- LAPEC
- Keywords
- Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAPECProcedure or surgery
Also called Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
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.
| Study group | Role | What they receive |
|---|---|---|
| LAPEC | Other | Patients with cecal percutaneous catheter placement. Receives: Procedure: LAPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement
Secondary outcomes (8)
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).
Measured: 3 months, 6 months, 12 months, 24 months
Removal rate
Proportion of patients with PEC in use and removed.
Measured: 12 months
Transit time
Change in x-ray transit time
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 1 month
Long-term adverse events
Incidence rate of adverse events during follow-up
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start20 May 2019
- Primary completion1 May 2023 (estimated)
- Study completion12 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cecostomy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Trnava
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Radovan Skuta, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909204
- Sponsor's protocol ID
- LAPEC for obstipation
- Status last verified
- Oct 2022
- First submitted
- 5 Apr 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC) in Adults for the Treatment of Severe Constipation
- ClinicalTrials.gov ID
- NCT03909204
- Acronym / sponsor ID
- LAPEC for obstipation
- Conditions
- Cecostomy; Complications, Constipation
- Keywords
- Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TrnavaResearch network
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 12 May 2023 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAPEC | Other | Procedure: LAPECPatients with cecal percutaneous catheter placement. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- Non-LAPEC cecostomy procedure
- Pre-existing severe electrolyte imbalance
- Chronic high rectal tone
- Advanced liver cirrhosis (Child B or Child C)
- Pregnancy or puerperium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAPECAlso: Laparoscopic-Assisted Percutaneous Endoscopic CecostomyLaparoscopic-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. | Procedure or surgery | LAPEC |
Primary outcome
Change in Bowel QoL
Time frame: Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement
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).
8 secondary outcomes
Change in Bowel QoL
Time frame: 3 months, 6 months, 12 months, 24 months
Removal rate
Time frame: 12 months
Transit time
Time frame: At 3 and 12 month after PEC placement
Frequency and Severity of Abdominal Pain
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
Flush Administration Time
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
Flush volume
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
Procedural adverse event
Time frame: 1 month
Long-term adverse events
Time frame: 3, 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radovan Skuta contact
Radovan Skuta principal investigator
Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAPEC in people with Cecostomy; Complications and Constipation, run by University Hospital Trnava at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rastislav Hustak (00421918905728, rhustak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bowel QoL (time frame: Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.