ConstipationCONSTICAP 2NCT07160192
Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation
An observational study of Constipation and Refractory, run by Nantes University Hospital at 1 site in France.
Trial summary
This observational monocentric study aims to evaluate the long-term effectiveness and tolerance of percutaneous endoscopic caecostomy (PEC) in patients with chronic refractory constipation. Follow-up data will be collected through phone interviews and standardized quality of life questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Refractory
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 20 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with refractory constipation treated with PEC at CHU Nantes.
Who may be able to join
- Adult patient
- Received PEC at CHU de Nantes
- Affiliated to French social security
- Non-opposition obtained
Who cannot join
- No PEC placement
- Protected adults or unable to respond
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Emmanuel CORON, UH Practitioner, +33240083152, emmanuel.coron@chu-nantes.fr
Emmanuel CORON, UH Practitioner
About this study
Official title: Monocentric, Non-interventional Study Evaluating the Long-term Outcomes of Percutaneous Endoscopic Caecostomy (PEC) in Patients With Refractory Chronic Constipation
This observational monocentric study aims to evaluate the long-term effectiveness and tolerance of percutaneous endoscopic caecostomy (PEC) in patients with chronic refractory constipation. Follow-up data will be collected through phone interviews and standardized quality of life questionnaires.
Read the detailed description
CONSTICAP 2 is a non-interventional cohort study conducted at CHU de Nantes. Patients who received a PEC between 2010 and 2022 will be contacted by phone at least two years after the procedure. Data will be collected using validated questionnaires (GIQLI, SF-36, etc.) to assess quality of life and treatment durability. The study builds on baseline and short-term data from the CONSTICAPE 1 cohort.
- Conditions
- Constipation, Refractory
- Keywords
- Caecostomy, Endoscopy, Constipation, GIQLI, Long-term evaluation, SF-36
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long-term success rate of PEC | Composite outcome: (1) catheter still in place, (2) symptom improvement (GIQLI and KESS), and (3) positive answer to "Would you recommend this technique to someone with the same condition?" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint (cf. Description Primary Outcomes 1 to 5):
- Catheter removal: positive if definitive removal without reimplantation at the time of the last update.
Measured: At 2 years of follow-up.
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpointt (cf. Description Primary Outcomes 1 to 5):
- GIQLI: positive if GIQLI ≥ +10 points vs. baseline.
Measured: At 2 years of follow-up.
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint:
(cf. Description Primary Outcomes 1 to 5):
- Kess: positive if Kess ≤ -5 points vs. baseline.
Measured: At 2 years of follow-up.
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint: (cf. Description Primary Outcomes 1 to 5):
- Kess: positive if Kess ≤ -5 points vs. baseline.
Measured: At 2 years of follow-up.
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint: (cf. Description Primary Outcomes 1 to 5):
- Rule: composite success = 3/3 positive components.
Measured: At 2 years of follow-up.
Secondary outcomes (7)
Assessment of quality of life using the SF-36 scale
Collection of SF36 scores at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study). Score between 0 and 100 ; the more elevated, better is the outcome.
Measured: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Assessment of gastrointestinal quality of life using the GIQLI scale (Gastrointestinal Quality of Life Index)
Collection of GIQLI score at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study).
Score between 0 and 144; the more elevated, better is the outcome.
Measured: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Measures constipation severity using the KESS scale ((symptom scoring system for constipation)
Collection of Kess score at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study).
Score between 0 and 39; the more elevated, worst is the outcome (severe constipation).
Measured: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Assesses fecal incontinence using Cleveland scale
Collection of Cleveland score (Cleveland Clinic Fecal Incontinence Score (Jorge-Wexner, CCFIS)) at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study).
Score between 0 and 20; the more elevated, worst is the outcome.
Measured: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Measures neurogenic bowel dysfunction using NBD scale ((Neurogenic Bowel Dysfunction)
For patients with spina bifida and/or spinal cord injuries, Neurogenic Bowel Dysfunction (NBD) scores at 1, 3, 6, 9, and 12 months (previous Consticape study) Score between 0 and 47; the more elevated, worst is the outcome. Validated categories: 0-6 very minor, 7-9 minor, 10-13 moderate, ≥ 14 severe
Measured: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Complications
Compilation of possible immediate or delayed complications during follow-up for up to 12 months (previous Consticape study)
Measured: Throughout the 12-month follow-up.
Device Tolerance using EVA scale
Visual Analog Scale (VAS) for pain assessment at 15 days, 1, 3, 6, 9, and 12 months (previous Consticape study), collection of any complications and treatments taken by the patient (previous Consticape study and follow-up after at least 2 years) Score between 0 and 10; the more elevated, worst is the outcome. Commonly used categories: ≤ 3.4 mild, 3.5-7.4 moderate, ≥ 7.5 severe.
Measured: 15 days, 1, 3, 6, 9, and 12 months and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160192
- Sponsor's protocol ID
- RC25_0207
- Acronym
- CONSTICAP 2
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Non-interventional Study Evaluating the Long-term Outcomes of Percutaneous Endoscopic Caecostomy (PEC) in Patients With Refractory Chronic Constipation
- ClinicalTrials.gov ID
- NCT07160192
- Acronym / sponsor ID
- CONSTICAP 2 / RC25_0207
- Conditions
- Constipation, Refractory
- Keywords
- Caecostomy, Endoscopy, Constipation, GIQLI, Long-term evaluation, SF-36
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 8 Sep 2025 (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.
This observational monocentric study aims to evaluate the long-term effectiveness and tolerance of percutaneous endoscopic caecostomy (PEC) in patients with chronic refractory constipation. Follow-up data will be collected through phone interviews and standardized quality of life questionnaires.
Detailed description
CONSTICAP 2 is a non-interventional cohort study conducted at CHU de Nantes. Patients who received a PEC between 2010 and 2022 will be contacted by phone at least two years after the procedure. Data will be collected using validated questionnaires (GIQLI, SF-36, etc.) to assess quality of life and treatment durability. The study builds on baseline and short-term data from the CONSTICAPE 1 cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term success rate of PEC | – | –Composite outcome: (1) catheter still in place, (2) symptom improvement (GIQLI and KESS), and (3) positive answer to "Would you recommend this technique to someone with the same condition?" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with refractory constipation treated with PEC at CHU Nantes.
Key inclusion criteria (4 listed)
- Adult patient
- Received PEC at CHU de Nantes
- Affiliated to French social security
- Non-opposition obtained
Key exclusion criteria (3 listed)
- No PEC placement
- Protected adults or unable to respond
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the long-term quality of life of patients
Time frame: At 2 years of follow-up.
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint (cf. Description Primary Outcomes 1 to 5): - Catheter removal: positive if definitive removal without reimplantation at the time of the last update.
Evaluation of the long-term quality of life of patients
Time frame: At 2 years of follow-up.
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpointt (cf. Description Primary Outcomes 1 to 5): - GIQLI: positive if GIQLI ≥ +10 points vs. baseline.
Evaluation of the long-term quality of life of patients
Time frame: At 2 years of follow-up.
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint: (cf. Description Primary Outcomes 1 to 5): - Kess: positive if Kess ≤ -5 points vs. baseline.
Evaluation of the long-term quality of life of patients
Time frame: At 2 years of follow-up.
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint: (cf. Description Primary Outcomes 1 to 5): - Kess: positive if Kess ≤ -5 points vs. baseline.
Evaluation of the long-term quality of life of patients
Time frame: At 2 years of follow-up.
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint: (cf. Description Primary Outcomes 1 to 5): - Rule: composite success = 3/3 positive components.
7 secondary outcomes
Assessment of quality of life using the SF-36 scale
Time frame: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Assessment of gastrointestinal quality of life using the GIQLI scale (Gastrointestinal Quality of Life Index)
Time frame: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Measures constipation severity using the KESS scale ((symptom scoring system for constipation)
Time frame: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Assesses fecal incontinence using Cleveland scale
Time frame: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Measures neurogenic bowel dysfunction using NBD scale ((Neurogenic Bowel Dysfunction)
Time frame: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Complications
Time frame: Throughout the 12-month follow-up.
Device Tolerance using EVA scale
Time frame: 15 days, 1, 3, 6, 9, and 12 months and at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Refractory, run by Nantes University Hospital at 1 site in France.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research and Innovation Departement of Nantes UH (+33253482810, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the long-term quality of life of patients (time frame: At 2 years of follow-up.). The study lists 5 primary outcomes in all. 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 8 Sep 2025.