Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation

Not yet recruiting

• Conditions: Constipation; Refractory

• Registration Number: NCT07160192
• Lead Sponsor: Nantes University Hospital

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.

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.

Study Timeline

• Study First Submitted: 2025-06-06
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study Start: 2025-09-01
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the long-term quality of life of patients	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 Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	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).
Assesses fecal incontinence using Cleveland scale	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.
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.	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
Complications	Throughout the 12-month follow-up.	Compilation of possible immediate or delayed complications during follow-up for up to 12 months (previous Consticape study)
Device Tolerance using EVA scale	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.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France