Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon

NCT ID: NCT04340856

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-07

Study Completion Date

2022-03-15

Brief Summary

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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

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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

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Megacolon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Chronic megacolon (colon diameter \> 90 mm)

Exclusion Criteria

* Toxic megacolon
* Ogilvie-syndrome
* Hirschsprung disease
* Mechanical colorectal obstruction
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role collaborator

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Schmitz, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg

Locations

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Theresienkrankenhaus und St. Hedwigkliniken GmbH

Mannheim, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 17547862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25868630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30953226 (View on PubMed)

Schmitz 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.

Reference Type DERIVED
PMID: 39260392 (View on PubMed)

Other Identifiers

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Chronic Megacolon 001

Identifier Type: -

Identifier Source: org_study_id

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