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Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04340856
Acronym
CoMeC
Enrollment
67
Registered
2020-04-10
Start date
2020-05-07
Completion date
2022-03-15
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Megacolon

Keywords

Megacolon

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.

Interventions

PROCEDUREcolon 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.

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.

Sponsors

Technical University of Munich
CollaboratorOTHER
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Chronic megacolon (colon diameter \> 90 mm)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
ConstipationOne year after inpatient treatment (conservative/surgery)Number of constipation crises leading to further hospital admissions: n

Secondary

MeasureTime frameDescription
Hospital stayThree months after inpatient treatment (conservative/surgery)Hospital stay after inpatient treatment (conservative/surgery): days
Adverse events30 days after inpatient treatment (conservative/surgery)Any adverse event after inpatient treatment (conservative/surgery): n

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026