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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
Sponsor study identifier
observational
103
1 country
1
Study Start
November 13, 2018
Actual (reported)Primary Completion
June 3, 2019
Actual (reported)Study Completion
December 20, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2018
Actual (reported)November 13, 2018
Actual (reported)June 3, 2019
Actual (reported)December 20, 2019
Actual (reported)September 10, 2021
Actual (reported)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
constipation
one year
anal incontinence
one year
The percutaneous caecal access is performed surgically
The percutaneous caecal acces is performed endoscopically.
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.
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.
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.
CHU de Nantes
Nantes, Loire-Atlantique, 44000, France
Emilie Duchalais, PH
Nantes University Hospital
103 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2018
First Posted
September 10, 2021
Study Start
November 13, 2018
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 3, 2019
Actual (reported)Study Completion
December 20, 2019
Actual (reported)Last Updated
September 17, 2021
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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