Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation

NCT07160192 | Not Yet Recruiting

• 1 other identifier: RC25_0207
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Refractory

Keywords

Caecostomy; Endoscopy; Constipation; GIQLI; Long-term evaluation; SF-36

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  At 2 years of follow-up.

Secondary Outcomes (7)

• Assessment of quality of life using the SF-36 scale

  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)

  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)

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

• Assesses fecal incontinence using Cleveland scale

  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)

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

Study Arms (1)

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?"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with refractory constipation treated with PEC at CHU Nantes.

You may qualify if:

• Adult patient
• Received PEC at CHU de Nantes
• Affiliated to French social security
• Non-opposition obtained

You may not qualify if:

• No PEC placement
• Protected adults or unable to respond
• Refusal to participate

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Research and Innovation Departement of Nantes UH

CONTACT

+33253482810; bp-prom-regl@chu-nantes.fr

Emmanuel CORON, UH Practitioner

CONTACT

+33240083152; emmanuel.coron@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)