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

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ClinicalTrials.gov Identifier: NCT04340856
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Theresienkrankenhaus und St. Hedwig-Klinik GmbH

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.

Condition or disease Intervention/treatment
Megacolon Procedure: colon surgery Drug: Laxatives

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective, Uncontrolled Multcentric Cohort Study on the Therapy of Chronic Megalon (CoMeC)
Estimated Study Start Date : May 7, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • 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.
    Other Names:
    • Subtotal colectomy with ileorectal anastomosis
    • Diverting loop ileostomy
    • Colectomy with ileoanal anastomosis
    • Decompressive cecostomy with periodic antegrade enemas
    • Segmental colon resection
  • 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.
    Other Names:
    • High-colonic water enema
    • Water-soluble contrast enema
    • PEG electrolyte solution
    • Colon decompression probe
    • Prucaloprid
    • Bisacodyl


Primary Outcome Measures :
  1. Constipation [ Time Frame: One year after inpatient treatment (conservative/surgery) ]
    Number of constipation crises leading to further hospital admissions: n


Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: Three months after inpatient treatment (conservative/surgery) ]
    Hospital stay after inpatient treatment (conservative/surgery): days

  2. Adverse events [ Time Frame: 30 days after inpatient treatment (conservative/surgery) ]
    Any adverse event after inpatient treatment (conservative/surgery): n



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Chronic megacolon (colon diameter > 90 mm)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340856


Contacts
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Contact: Daniel Schmitz, PhD,MD +496214245575 d.schmitz@theresienkrankenhaus.de

Sponsors and Collaborators
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Technische Universität München
Investigators
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Principal Investigator: Daniel Schmitz, PhD, MD Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg
Publications:
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Responsible Party: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
ClinicalTrials.gov Identifier: NCT04340856    
Other Study ID Numbers: Chronic Megacolon 001
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theresienkrankenhaus und St. Hedwig-Klinik GmbH:
Megacolon
Additional relevant MeSH terms:
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Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bisacodyl
Laxatives
Cathartics
Gastrointestinal Agents