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NCT Number: NCT04340856

Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon

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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Key information

Conditions

Megacolon Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Theresienkrankenhaus und St. Hedwigkliniken GmbH

Mannheim, 68165, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic megacolon (colon diameter > 90 mm)

Exclusion criteria

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

Treatment and study plan

Colon surgery

Procedure

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

Laxatives

Drug

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 outcomes

  1. Constipation

    Time frame: One year after inpatient treatment (conservative/surgery)

    Number of constipation crises leading to further hospital admissions: n

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Other

Collaborators

  • Technical University of Munich

Registry information

Official study title

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

Acronym: CoMeC

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 10, 2020
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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