Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment (ConstiCAPE)

The investigators' study aims to compare the results of percutaneous endoscopic caecostomie (CPE) to optimal medical therapy in the treatment of patients with constipation refractory to medical treatment. The primary endpoint will be the quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI) at one year. The secondary endpoints are digestive symptoms, Kess's constipation scores and Cleveland's incontinence score, tolerance of the Chait TrapdoorTM caecostomy catheter (CTCC) and the collection of possible complications. The patients included must meet the classification criteria of Rome III, have an elongated colonic transit time, have had a complete colonoscopy and be refractory to medical treatment including at least one stimulant laxative or suppositories or enemas retrograde.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Device: Chait Trapdoor caecostomie catheter; Drug: continuation of optimal medical therapy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes
  • Ploemeur, France, 56270
    • CMRRF de Kerpape
  • Rouen, France
    • CHU de Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient betwen 18 and 75 years old
• Chronic constipation defined by the Rome III classification
• Transit time with pellets made within 24 months preceding the inclusion visit indicating a transit time of at least 120 hours and/or with a Neurogenic bowel dysfunction ≥ 14 for patients with spina bifida and / or spinal cord injuries.
• Colonoscopy made within the 5 years preceding the inclusion visit indicating the absence of colorectal organic obstacle
• Anorectal manometry performed within 24 months preceding the inclusion visit performed to substantiate the information on the type of constipation
• GIQLI score <121 and Kess Questionnaire score> 7, despite medical treatment of constipation including taking a laxative (stimulant laxative orally and / or suppository and / or retrograde enema) more than one times per week for at least two months.
• Affiliation to a social security
• - Chronic constipation defined by the Rome III classification
• Transit time with pellets made within 24 months preceding the inclusion visit indicating an increase of at least 120 hours compared to normal
• Colonoscopy made within the 24 months preceding the inclusion visit indicating the absence of colorectal organic obstacle
• Anorectal manometry performed in the 24 months preceding the inclusion visit performed to substantiate the information on the type of constipation
• Score GIQLI love <121 and Kess Questionnaire score> 7, despite medical treatment of constipation including taking a laxative (stimulant laxative orally and / or suppository and / or retrograde enema) more than one times per week for at least two months.
• Affiliation to a social security scheme
• Informed consent signed

Exclusion Criteria:

• Severe obesity (BMI> 40)
• History of surgical resection of colon
• Hypothyroidism, electrolyte disorders, insulin-dependent diabetes
• Acute decompensation of depressive syndrome
• Immunosuppressive therapy
• Disorders of hemostasis (TP <70%, APTT> 1.5, thrombocytopenia <70,000 / mm3)
• Pregnant woman (positive serum beta-hCG) or breastfeeding
• Adults under guardianship, curatorship or under court protection
• Participation in another research protocol on the treatment of constipation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chait Trapdoor caecostomie catheter; Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter	Device: Chait Trapdoor caecostomie catheter; implantation of the Chait Trapdoor caecostomie catheter
Active Comparator: Continuation of optimal medical therapy; Patients randomized in this arm will continue this medical treatment of constipation with laxative and / or suppositories and / or enemas retrograde during 12 months. At 12 months : patients will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter during 12 months.	Device: Chait Trapdoor caecostomie catheter; implantation of the Chait Trapdoor caecostomie catheter; Drug: continuation of optimal medical therapy; continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter; Other Names: Chait Trapdoor caecostomie catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (Gastrointestinal Quality Of Life Index)	assessed by the Gastrointestinal Quality Of Life Index (GIQLI)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (Gastrointestinal Quality Of Life Index)	Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)	21 months
Evolution of the Quality of life (SF-36 score)	Evolution of the SF-36 score	2 years
Constipation score (Kess score)	Evolution of the Kess score	2 years
Incontinence score (Cleveland score)	Evolution of the Cleveland score	2 years
Neurogenic bowel dysfunction score	Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries	2 years
Tolerance to the CTCC (Visual Analogue Scale)	Evolution of the tolerance to the CHAIT Trapdoor caecostomy catheter on a skin and abdominal level with Visual Analogue Scale	2 years
Constipation treatments	Type of constipation treatments taken by the patient during the study and analysis of compliance	2 years
Complications	Reports of immediate or delayed complications	2 years

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2016
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: RC15_0041