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CompletedNCT02566746ConstiCAPEUpdated Jan 27, 2023

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

An interventional study of Chait Trapdoor caecostomie catheter and continuation of optimal medical therapy in Constipation, sponsored by Nantes University Hospital. Completed at 3 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-27.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Constipation

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03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 28 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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 · Drug: continuation of optimal medical therapy

Interventions

  • DeviceChait Trapdoor caecostomie catheter

    implantation of the Chait Trapdoor caecostomie catheter

  • Drugcontinuation 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

    Also known as: Chait Trapdoor caecostomie catheter

06

What researchers measure

Primary outcomes

  1. Quality of life (Gastrointestinal Quality Of Life Index)

    assessed by the Gastrointestinal Quality Of Life Index (GIQLI)

    Time frame: 1 year

Secondary outcomes

  1. Quality of life (Gastrointestinal Quality Of Life Index)

    Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)

    Time frame: 21 months

  2. Evolution of the Quality of life (SF-36 score)

    Evolution of the SF-36 score

    Time frame: 2 years

  3. Constipation score (Kess score)

    Evolution of the Kess score

    Time frame: 2 years

  4. Incontinence score (Cleveland score)

    Evolution of the Cleveland score

    Time frame: 2 years

  5. Neurogenic bowel dysfunction score

    Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries

    Time frame: 2 years

  6. 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

    Time frame: 2 years

  7. Constipation treatments

    Type of constipation treatments taken by the patient during the study and analysis of compliance

    Time frame: 2 years

  8. Complications

    Reports of immediate or delayed complications

    Time frame: 2 years

07

Study locations

3 sites
  • CHU de Nantes
    Nantes, 44093, France
  • CMRRF de Kerpape
    Ploemeur, 56270, France
  • CHU de Rouen
    Rouen, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02566746
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Oct 2, 2015
Start date
Jun 20, 2016
Primary completion
Jun 23, 2022
Completion
Jun 23, 2022
Last update
Jan 27, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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