Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation (CONSTICAP 2)

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Refractory; Constipation

Study type: Observational

Funder types: Other

Identifiers

NCT07160192

RC25_0207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Long-term success rate of PEC

Description:

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?"