Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon

Megacolon Clinical Trial

— CoMeC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340856
• Other study ID #: Chronic Megacolon 001
• Status: Completed
• Start date: May 7, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: April 2022
• Source: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Chronic megacolon (colon diameter > 90 mm)

Exclusion Criteria:

• Toxic megacolon

• Ogilvie-syndrome

• Hirschsprung disease

• Mechanical colorectal obstruction

Related Conditions & MeSH terms

• Megacolon

Intervention

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.

Locations

Country	Name	City	State
Germany	Theresienkrankenhaus und St. Hedwigkliniken GmbH	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Theresienkrankenhaus und St. Hedwig-Klinik GmbH	Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Hanauer SB, Wald A. Acute and chronic megacolon. Curr Treat Options Gastroenterol. 2007 Jun;10(3):237-47. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constipation	Number of constipation crises leading to further hospital admissions: n	One year after inpatient treatment (conservative/surgery)
Secondary	Hospital stay	Hospital stay after inpatient treatment (conservative/surgery): days	Three months after inpatient treatment (conservative/surgery)
Secondary	Adverse events	Any adverse event after inpatient treatment (conservative/surgery): n	30 days after inpatient treatment (conservative/surgery)