A Comparison of Quality of Life Between MAlone Procedure and Percutaneaous Endoscopic Caecostomy in Patients With Antegrade Colonic Enema

Fecal Incontinence With Fecal Urgency Clinical Trial

— MAPEC  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040139
• Other study ID #: RC17_0080
• Status: Completed
• Start date: November 13, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Constipation
• Constipation Aggravated
• Fecal Incontinence
• Fecal Incontinence With Fecal Urgency

Intervention

Procedure:
• Malone Procedure
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
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.

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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