ConstipationConstiCAPENCT02566746
Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment
A study testing Chait Trapdoor caecostomie catheter and continuation of optimal medical therapy in people with Constipation, run by Nantes University Hospital at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- Chait Trapdoor caecostomie catheter and continuation of optimal medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Jun 2016to 23 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Nantes
Nantes, 44093
CMRRF de Kerpape
Ploemeur, 56270
CHU de Rouen
Rouen
About this study
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.
- Conditions
- Constipation
- Being tested
- Chait Trapdoor caecostomie catheter, continuation of optimal medical therapy
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chait Trapdoor caecostomie catheterDevice
implantation of the Chait Trapdoor caecostomie catheter
continuation of optimal medical therapyDrug
Also called Chait Trapdoor caecostomie catheter
continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter
| Study group | Role | What they receive |
|---|---|---|
| Chait Trapdoor caecostomie catheter | Experimental | Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter Receives: Device: Chait Trapdoor caecostomie catheter |
| Continuation of optimal medical therapy | Active comparator | 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. Receives: Device: Chait Trapdoor caecostomie catheter; Drug: continuation of optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (Gastrointestinal Quality Of Life Index)
assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
Measured: 1 year
Secondary outcomes (8)
Quality of life (Gastrointestinal Quality Of Life Index)
Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
Measured: 21 months
Evolution of the Quality of life (SF-36 score)
Evolution of the SF-36 score
Measured: 2 years
Constipation score (Kess score)
Evolution of the Kess score
Measured: 2 years
Incontinence score (Cleveland score)
Evolution of the Cleveland score
Measured: 2 years
Neurogenic bowel dysfunction score
Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries
Measured: 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
Measured: 2 years
Constipation treatments
Type of constipation treatments taken by the patient during the study and analysis of compliance
Measured: 2 years
Complications
Reports of immediate or delayed complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start20 Jun 2016
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566746
- Sponsor's protocol ID
- RC15_0041
- Acronym
- ConstiCAPE
- Status last verified
- Jan 2023
- First submitted
- 1 Oct 2015
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Lefevre C, Le Roy C, Bessard A, Le Berre-Scoul C, Marchix J, Coron E, Le Rhun M, Brochard C, Perrouin-Verbe B, Neunlist M. Region-specific remodeling of the enteric nervous system and enteroendocrine cells in the colon of spinal cord injury patients. Sci Rep. 2023 Oct 6;13(1):16902. doi: 10.1038/s41598-023-44057-y.
PubMed 37803037
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment
- ClinicalTrials.gov ID
- NCT02566746
- Acronym / sponsor ID
- ConstiCAPE / RC15_0041
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chait Trapdoor caecostomie catheter | Experimental | Device: Chait Trapdoor caecostomie catheterPatients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter |
| Continuation of optimal medical therapy | Active comparator | Device: Chait Trapdoor caecostomie catheter, Drug: continuation of optimal medical therapyPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- Severe obesity (BMI> 40)
- History of surgical resection of colon
- Hypothyroidism, electrolyte disorders, insulin-dependent diabetes
- Acute decompensation of depressive syndrome
- Immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chait Trapdoor caecostomie catheterimplantation of the Chait Trapdoor caecostomie catheter | Device | Chait Trapdoor caecostomie catheter, Continuation of optimal medical therapy |
| continuation of optimal medical therapyAlso: Chait Trapdoor caecostomie cathetercontinuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter | Drug | Continuation of optimal medical therapy |
Primary outcome
Quality of life (Gastrointestinal Quality Of Life Index)
Time frame: 1 year
assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
8 secondary outcomes
Quality of life (Gastrointestinal Quality Of Life Index)
Time frame: 21 months
Evolution of the Quality of life (SF-36 score)
Time frame: 2 years
Constipation score (Kess score)
Time frame: 2 years
Incontinence score (Cleveland score)
Time frame: 2 years
Neurogenic bowel dysfunction score
Time frame: 2 years
Tolerance to the CTCC (Visual Analogue Scale)
Time frame: 2 years
Constipation treatments
Time frame: 2 years
Complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Derived from this study: PubMed 37803037Lefevre C, Le Roy C, Bessard A, Le Berre-Scoul C, Marchix J, Coron E, Le Rhun M, Brochard C, Perrouin-Verbe B, Neunlist M. Region-specific remodeling of the enteric nervous system and enteroendocrine cells in the colon of spinal cord injury patients. Sci Rep. 2023 Oct 6;13(1):16902. doi: 10.1038/s41598-023-44057-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chait Trapdoor caecostomie catheter and continuation of optimal medical therapy in people with Constipation, run by Nantes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (Gastrointestinal Quality Of Life Index) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.