Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Constipation, Refractory. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Monocentric, Non-interventional Study Evaluating the Long-term Outcomes of Percutaneous Endoscopic Caecostomy (PEC) in Patients With Refractory Chronic Constipation
Overview
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.
Primary outcome measures
- Evaluation of the long-term quality of life of patients [Time frame: At 2 years of follow-up.]
- Evaluation of the long-term quality of life of patients [Time frame: At 2 years of follow-up.]
- Evaluation of the long-term quality of life of patients [Time frame: At 2 years of follow-up.]
- Evaluation of the long-term quality of life of patients [Time frame: At 2 years of follow-up.]
- Evaluation of the long-term quality of life of patients [Time frame: At 2 years of follow-up.]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- Adult patient
- Received PEC at CHU de Nantes
- Affiliated to French social security
- Non-opposition obtained
Exclusion criteria
- No PEC placement
- Protected adults or unable to respond
- Refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Nantes University Hospital — Nantes
Identifiers
NCT: NCT07160192 · RC25_0207