- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040139
A Comparison of Quality of Life Between MAlone Procedure and Percutaneaous Endoscopic Caecostomy in Patients With Antegrade Colonic Enema (MAPEC)
A Comparative Study Between Malone Procedure and Percutaneaous Endoscopic Caecostomy in Patients Treated With Antegrade Colonic Enema for Severe Anal Incontinence and/or Constipation
Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes.
Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence.
Hypothesis: MP and PEC achieve similar quality of life outcomes. Methods: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). The main measured outcome will be GIQLI score.
Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes.
Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence.
Hypothesis: MP and PEC achieve similar quality of life outcomes. Study design: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted by mail to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). Patients who did not answer to the mail will be phoned. The collection of patients' answers will be conducted over a 3 months period.
Main outcome measures: Quality of life evaluated by the GIQLI score. Secondary outcomes measures: Functional outcomes including constipation severity (measured by the KESS score), fecal incontinence severity (measured by the Wexner score), body image impairment (measured by the BIQ score).
Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Loire-Atlantique
-
Nantes, Loire-Atlantique, France, 44000
- CHU de Nantes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Severe constipation and/or severe incontinence refractory to medical treatment.
Exclusion Criteria:
- Malone procedure or percutaneous endoscopic caecostomy between 2006 and 2016
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Malone procedure
The percutaneous caecal access is performed surgically
|
Surgical procedure performed to obtain a percutaneous caecal access for the administration of antegrade colonic enemas.
Briefly, the procedure is performed under general anesthesia.
The surgeon bring the end of the appendix (or a tubulized segment of the ileum) out through the abdominal wall.
The appendix is opened and sutured to the abdominal skin.
|
Percutaneous Endoscopic Caecostomy
The percutaneous caecal acces is performed endoscopically.
|
Endoscopic procedure performed to obtain a percutaneous caecal access for the administration of antegrade colonic enemas.
Briefly, a coloscopy is performed to reach the caecum.
The cutaneous location of the caecostomy is determined by transillumination of the caecum.
A caecopexy is performed with 3 anchors at the chosen location.
A specific pig-tail catheter (Chait catheter) is placed percutaneously into the caecum in the center of the 3 anchors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the quality of life of patients treated with anterograde colonic enemas after Malone surgical technique and percutaneous endoscopic caecostomy.
Time Frame: one year
|
Quality of life evaluated by the GastroIntestinal Quality of Life score (GIQLI). The GIQLI (GastroIntestinal Quality of Life) questionnaire consists of 36 questions giving a global quality of life score and 5 sub-scores (digestive symptoms, physical scale, mental scale, social scale and effects of drug treatments). |
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
constipation
Time Frame: one year
|
Constipation will be evaluated by the Kess constipation severity score.
The Kess questionnaire consists of 11 questions assessing the symptoms of constipation and giving a single score.
|
one year
|
anal incontinence
Time Frame: one year
|
Anal incontinence will be evaluated with the WEXNER score. - The Wexner questionnaire consists of 5 questions evaluating the symptoms of incontinence and giving a single score. |
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emilie Duchalais, PH, CHU de Nantes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC17_0080
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation Aggravated
-
Mayo ClinicCompletedConstipation Aggravated | Pelvic Floor; IncompetencyUnited States
-
ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
Sichuan Academy of Medical SciencesRecruitingPeritoneal Dialysis Complication | Renal Function Aggravated | Sodium-glucose Co-transporter-2 InhibitorsChina
-
Lexicon PharmaceuticalsSanofiTerminatedCardiac Failure AggravatedUnited States, Canada, Netherlands
-
University Hospital, LilleMinistry of Health, FranceTerminatedCrohn's Disease AggravatedFrance
-
usMIMA S.L.CompletedConstipation | Constipation Chronic Idiopathic | Constipation; NeurogenicSpain, United Kingdom
-
AbbVieIronwood Pharmaceuticals, Inc.RecruitingFunctional Constipation (FC) | Chronic Idiopathic Constipation (CIC)United States, United Kingdom, Bulgaria, Netherlands
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
SK Life Science, Inc.CompletedChronic Constipation | Functional ConstipationUnited States
Clinical Trials on Malone Procedure
-
NYU Langone HealthCompleted
-
Minia UniversityCompletedVisual Impairment | IOP DecreasedEgypt
-
Virginia Commonwealth UniversityCompletedPersonal Protective EquipmentUnited States
-
Major Extremity Trauma Research ConsortiumCompleted
-
CathVision ApSTRIQ GROUP Wherry & Klaffke GbRCompletedCardiac ArrhythmiaDenmark, Czechia
-
University Hospital, ToulouseCompletedTobacco Use DisorderFrance
-
University of North Carolina, Chapel HillUniversity of Maryland, Baltimore; National Eye Institute (NEI); OrbisCompletedSurgery | TrichiasisEthiopia
-
Christiana Care Health ServicesCompletedConsequences of Immunization MethodUnited States
-
Carmen Rosa PallasHospital Universitario 12 de OctubreUnknown
-
McMaster UniversityRecruitingShoulder Dislocation | Sport Injuries | Anterior DislocationCanada