Fecal Incontinence With Fecal Urgency Clinical Trial
— MAPECOfficial title:
A Comparative Study Between Malone Procedure and Percutaneaous Endoscopic Caecostomy in Patients Treated With Antegrade Colonic Enema for Severe Anal Incontinence and/or Constipation
Verified date | September 2021 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | December 20, 2019 |
Est. primary completion date | June 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Severe constipation and/or severe incontinence refractory to medical treatment. Exclusion Criteria: - Malone procedure or percutaneous endoscopic caecostomy between 2006 and 2016 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nantes | Nantes | Loire-Atlantique |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the quality of life of patients treated with anterograde colonic enemas after Malone surgical technique and percutaneous endoscopic caecostomy. | 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 | constipation | 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 | |
Secondary | anal incontinence | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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