Clinical trial NCT04340856: Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon
Official title: Retrospective, Uncontrolled Multcentric Cohort Study on the Therapy of Chronic Megalon (CoMeC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Megacolon
Keywords: Megacolon
Lead sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2020-04-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The databases of three clinical centers were systematically screened for patients with chronic megacolon (exclusion/inclusion criteria) in the time frame from 1.5.2005 to 1.5.2020.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Chronic megacolon (colon diameter \> 90 mm)

Exclusion Criteria:

* Toxic megacolon
* Ogilvie-syndrome
* Hirschsprung disease
* Mechanical colorectal obstruction

Primary outcomes:
measure: Constipation
timeFrame: One year after inpatient treatment (conservative/surgery)
Secondary outcomes:
measure: Hospital stay
timeFrame: Three months after inpatient treatment (conservative/surgery)
measure: Adverse events
timeFrame: 30 days after inpatient treatment (conservative/surgery)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Theresienkrankenhaus und St. Hedwigkliniken GmbH
Study officials:
affiliation: Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg
name: Daniel Schmitz, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanauer SB, Wald A. Acute and chronic megacolon. Curr Treat Options Gastroenterol. 2007 Jun;10(3):237-47. doi: 10.1007/s11938-007-0017-z.
citation: O'Dwyer RH, Acosta A, Camilleri M, Burton D, Busciglio I, Bharucha AE. Clinical Features and Colonic Motor Disturbances in Chronic Megacolon in Adults. Dig Dis Sci. 2015 Aug;60(8):2398-407. doi: 10.1007/s10620-015-3645-5. Epub 2015 Apr 14.
citation: Wang XJ, Camilleri M. Chronic Megacolon Presenting in Adolescents or Adults: Clinical Manifestations, Diagnosis, and Genetic Associations. Dig Dis Sci. 2019 Oct;64(10):2750-2756. doi: 10.1007/s10620-019-05605-7. Epub 2019 Apr 5.