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

April 25, 2022 updated by: Theresienkrankenhaus und St. Hedwig-Klinik GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68165
        • Theresienkrankenhaus und St. Hedwigkliniken GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Chronic megacolon (colon diameter > 90 mm)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Collaborators

Technical University of Munich

Investigators

  • Principal Investigator: Daniel Schmitz, PhD, MD, Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chronic Megacolon 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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