MegacolonCoMeCNCT04340856
Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon
An observational study of Megacolon, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Megacolon
- What is being tested?
- colon surgery and Laxatives
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- 7 May 2020to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Chronic megacolon (colon diameter > 90 mm)
Who cannot join
- Toxic megacolon
- Ogilvie-syndrome
- Hirschsprung disease
- Mechanical colorectal obstruction
Trial locations and contacts
1 site in 1 country.
Germany1 site
Theresienkrankenhaus und St. Hedwigkliniken GmbH
Mannheim, 68165
About this study
Official title: 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.
Read the 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.
- Conditions
- Megacolon
- Being tested
- colon surgery, Laxatives
- Keywords
- Megacolon
- Medical subject headings
- Megacolon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colon surgeryProcedure or surgery
Also called Subtotal colectomy with ileorectal anastomosis, Diverting loop ileostomy, Colectomy with ileoanal anastomosis, Decompressive cecostomy with periodic antegrade enemas
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.
LaxativesDrug
Also called High-colonic water enema, Water-soluble contrast enema, PEG electrolyte solution, Colon decompression probe
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation
Number of constipation crises leading to further hospital admissions: n
Measured: One year after inpatient treatment (conservative/surgery)
Secondary outcomes (2)
Hospital stay
Hospital stay after inpatient treatment (conservative/surgery): days
Measured: Three months after inpatient treatment (conservative/surgery)
Adverse events
Any adverse event after inpatient treatment (conservative/surgery): n
Measured: 30 days after inpatient treatment (conservative/surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start7 May 2020
- Primary completion31 Dec 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MegacolonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Sponsor
- Investigators
- Daniel Schmitz, PhD, MD, Principal investigator, Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340856
- Sponsor's protocol ID
- Chronic Megacolon 001
- Acronym
- CoMeC
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanauer SB, Wald A. Acute and chronic megacolon. Curr Treat Options Gastroenterol. 2007 Jun;10(3):237-47. doi: 10.1007/s11938-007-0017-z.
PubMed 17547862O'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.
PubMed 25868630Wang 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.
PubMed 30953226Schmitz D, Meier E, Axt S, Arlt G, Kienle P, Johannink J, Konigsrainer A, Mohammad O, Jakobs R, Willis S, Demir IE, Friess H, Hetjens S, Ebert MP, Reissfelder C, Vassilev G. Conservative versus surgical therapy for idiopathic and secondary megacolon or megarectum in adults - a retrospective multicentre controlled study. Z Gastroenterol. 2024 Nov;62(11):1913-1923. doi: 10.1055/a-2360-5008. Epub 2024 Sep 11.
PubMed 39260392
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Uncontrolled Multcentric Cohort Study on the Therapy of Chronic Megalon (CoMeC)
- ClinicalTrials.gov ID
- NCT04340856
- Acronym / sponsor ID
- CoMeC / Chronic Megacolon 001
- Conditions
- Megacolon
- Keywords
- Megacolon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- 7 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Chronic megacolon (colon diameter > 90 mm)
Key exclusion criteria (4 listed)
- Toxic megacolon
- Ogilvie-syndrome
- Hirschsprung disease
- Mechanical colorectal obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colon surgeryAlso: Subtotal colectomy with ileorectal anastomosis, Diverting loop ileostomy, Colectomy with ileoanal anastomosis, Decompressive cecostomy with periodic antegrade enemasThere 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. | Procedure or surgery | – |
| LaxativesAlso: High-colonic water enema, Water-soluble contrast enema, PEG electrolyte solution, Colon decompression probeThere 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. | Drug | – |
Primary outcome
Constipation
Time frame: One year after inpatient treatment (conservative/surgery)
Number of constipation crises leading to further hospital admissions: n
2 secondary outcomes
Hospital stay
Time frame: Three months after inpatient treatment (conservative/surgery)
Adverse events
Time frame: 30 days after inpatient treatment (conservative/surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 17547862Hanauer SB, Wald A. Acute and chronic megacolon. Curr Treat Options Gastroenterol. 2007 Jun;10(3):237-47. doi: 10.1007/s11938-007-0017-z.
- Background: PubMed 25868630O'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.
- Background: PubMed 30953226Wang 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.
- Derived from this study: PubMed 39260392Schmitz D, Meier E, Axt S, Arlt G, Kienle P, Johannink J, Konigsrainer A, Mohammad O, Jakobs R, Willis S, Demir IE, Friess H, Hetjens S, Ebert MP, Reissfelder C, Vassilev G. Conservative versus surgical therapy for idiopathic and secondary megacolon or megarectum in adults - a retrospective multicentre controlled study. Z Gastroenterol. 2024 Nov;62(11):1913-1923. doi: 10.1055/a-2360-5008. Epub 2024 Sep 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Schmitz, PhD, MD principal investigator
Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Megacolon, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation (time frame: One year after inpatient treatment (conservative/surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04340856, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.