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

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chait Trapdoor caecostomie catheter
continuation of optimal medical therapy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nantes
  • CMRRF de Kerpape
  • CHU de Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chait Trapdoor caecostomie catheter

Continuation of optimal medical therapy

Arm Description

Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life (Gastrointestinal Quality Of Life Index)
Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
Evolution of the Quality of life (SF-36 score)
Evolution of the SF-36 score
Constipation score (Kess score)
Evolution of the Kess score
Incontinence score (Cleveland score)
Evolution of the Cleveland score
Neurogenic bowel dysfunction score
Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries
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
Constipation treatments
Type of constipation treatments taken by the patient during the study and analysis of compliance
Complications
Reports of immediate or delayed complications

Full Information

First Posted
October 1, 2015
Last Updated
January 26, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02566746
Brief Title
Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment
Acronym
ConstiCAPE
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
June 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chait Trapdoor caecostomie catheter
Arm Type
Experimental
Arm Description
Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter
Arm Title
Continuation of optimal medical therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Chait Trapdoor caecostomie catheter
Intervention Description
implantation of the Chait Trapdoor caecostomie catheter
Intervention Type
Drug
Intervention Name(s)
continuation of optimal medical therapy
Other Intervention Name(s)
Chait Trapdoor caecostomie catheter
Intervention Description
continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter
Primary Outcome Measure Information:
Title
Quality of life (Gastrointestinal Quality Of Life Index)
Description
assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life (Gastrointestinal Quality Of Life Index)
Description
Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
Time Frame
21 months
Title
Evolution of the Quality of life (SF-36 score)
Description
Evolution of the SF-36 score
Time Frame
2 years
Title
Constipation score (Kess score)
Description
Evolution of the Kess score
Time Frame
2 years
Title
Incontinence score (Cleveland score)
Description
Evolution of the Cleveland score
Time Frame
2 years
Title
Neurogenic bowel dysfunction score
Description
Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries
Time Frame
2 years
Title
Tolerance to the CTCC (Visual Analogue Scale)
Description
Evolution of the tolerance to the CHAIT Trapdoor caecostomy catheter on a skin and abdominal level with Visual Analogue Scale
Time Frame
2 years
Title
Constipation treatments
Description
Type of constipation treatments taken by the patient during the study and analysis of compliance
Time Frame
2 years
Title
Complications
Description
Reports of immediate or delayed complications
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CMRRF de Kerpape
City
Ploemeur
ZIP/Postal Code
56270
Country
France
Facility Name
CHU de Rouen
City
Rouen
Country
France

12. IPD Sharing Statement

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

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