Clinical trial NCT05040139: A Comparison of Quality of Life Between MAlone Procedure and Percutaneaous Endoscopic Caecostomy in Patients With Antegrade Colonic Enema
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation Aggravated
Fecal Incontinence With Fecal Urgency
Keywords: Constipation
Fecal incontinence
Antegrade colonic enema
Percutaneous Endoscopic Caecostomy
Malone Procedure
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Severe constipation and/or severe incontinence refractory to medical treatment.

Exclusion Criteria:

* Malone procedure or percutaneous endoscopic caecostomy between 2006 and 2016

Primary outcomes:
measure: Comparison of the quality of life of patients treated with anterograde colonic enemas after Malone surgical technique and percutaneous endoscopic caecostomy.
timeFrame: one year
Secondary outcomes:
measure: constipation
timeFrame: one year
measure: anal incontinence
timeFrame: one year
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Emilie Duchalais, PH
role: PRINCIPAL_INVESTIGATOR
References: