Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation

NCT ID: NCT07160192

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-10-20

Brief Summary

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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

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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

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Constipation Refractory

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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?"

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status

Countries

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France

Central Contacts

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Research and Innovation Departement of Nantes UH

Role: CONTACT

+33253482810

Emmanuel CORON, UH Practitioner

Role: CONTACT

+33240083152

Facility Contacts

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Emmanuel CORON, UH Practitioner

Role: primary

+33240083152

Other Identifiers

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RC25_0207

Identifier Type: -

Identifier Source: org_study_id

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