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NCT Number: NCT07160192

Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory 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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Refractory Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location contact

Emmanuel CORON, UH Practitioner

CONTACT

[email protected]

+33240083152

Emmanuel CORON, UH Practitioner

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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).

  4. Assesses fecal incontinence using Cleveland scale

    Time frame: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.

    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.

  5. 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.

    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

  6. Complications

    Time frame: Throughout the 12-month follow-up.

    Compilation of possible immediate or delayed complications during follow-up for up to 12 months (previous Consticape study)

  7. Device Tolerance using EVA scale

    Time frame: 15 days, 1, 3, 6, 9, and 12 months and at 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel CORON, UH Practitioner

CONTACT

[email protected]

+33240083152

Research and Innovation Departement of Nantes UH

CONTACT

[email protected]

+33253482810

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Monocentric, Non-interventional Study Evaluating the Long-term Outcomes of Percutaneous Endoscopic Caecostomy (PEC) in Patients With Refractory Chronic Constipation

Acronym: CONSTICAP 2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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