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Completed

NCT Number: NCT02566746

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chait Trapdoor caecostomie catheter

Device

implantation of the Chait Trapdoor caecostomie catheter

continuation of optimal medical therapy

Drug

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

Primary outcomes

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

    Time frame: 1 year

    assessed by the Gastrointestinal Quality Of Life Index (GIQLI)

Secondary outcomes

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

    Time frame: 21 months

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

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

    Time frame: 2 years

    Evolution of the SF-36 score

  3. Constipation score (Kess score)

    Time frame: 2 years

    Evolution of the Kess score

  4. Incontinence score (Cleveland score)

    Time frame: 2 years

    Evolution of the Cleveland score

  5. Neurogenic bowel dysfunction score

    Time frame: 2 years

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

  6. Tolerance to the CTCC (Visual Analogue Scale)

    Time frame: 2 years

    Evolution of the tolerance to the CHAIT Trapdoor caecostomy catheter on a skin and abdominal level with Visual Analogue Scale

  7. Constipation treatments

    Time frame: 2 years

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

  8. Complications

    Time frame: 2 years

    Reports of immediate or delayed complications

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: ConstiCAPE

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 2, 2015
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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