Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon

Study Overview
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Brief Summary
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The aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.

Detailed Description
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Megacolon may be defined as dilatation of the abdominal colon with a minimum of 9 cm in diameter and the absence of mechanical obstruction. Chronic megacolon in adults is an acquired uncommon condition that generally is associated with constipation. It has to be distinguished from other forms of megacolon such as acute toxic megacolon, acute non-toxic megacolon (Ogilvie´s-syndrome) and congenital megacolon (Hirschsprung disease). Regardless of concomitant diseases and causes, most patients with chronic megacolon were treated by laxative measures. Less is known about the optimal conservative therapy . If conservative measures fail, there are several surgical options, depending upon anorectal function. However, less in known about the optimal surgical therapy of patients with chronic megacolon. The aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.

Official Title
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Retrospective, Uncontrolled Multcentric Cohort Study on the Therapy of Chronic Megalon (CoMeC)

Conditions
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Megacolon

Intervention / Treatment
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* Procedure: colon surgery
* Drug: Laxatives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic megacolon (colon diameter > 90 mm) Exclusion Criteria: Toxic megacolon Ogilvie-syndrome Hirschsprung disease Mechanical colorectal obstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: colon surgery|There are no guidelines to direct surgical therapy in patients with chronic megacolon. Historically, it is the surgeons individual choice to use one of the above mentioned surgical treatments. Therefore, the aim of this study is to analyze the success and downsides of the different surgical approaches.|
|Drug: Laxatives|There are no guidelines to direct laxative measures in patients with chronic megacolon. Historically, it is the gastroenterologists individual choice to use one of the above mentioned laxative measures. Therefore, the aim of this study is to analyze the success and downsides of the different Laxative measures.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation | Number of constipation crises leading to further hospital admissions: n | One year after inpatient treatment (conservative/surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Hospital stay after inpatient treatment (conservative/surgery): days | Three months after inpatient treatment (conservative/surgery) | 
| Adverse events | Any adverse event after inpatient treatment (conservative/surgery): n | 30 days after inpatient treatment (conservative/surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Megacolon