NCT04340856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

May 7, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

April 7, 2020

Last Update Submit

April 25, 2022

Conditions

Megacolon

Keywords

Megacolon

Outcome Measures

Primary Outcomes (1)

  • Constipation

    Number of constipation crises leading to further hospital admissions: n

    One year after inpatient treatment (conservative/surgery)

Secondary Outcomes (2)

  • Hospital stay

    Three months after inpatient treatment (conservative/surgery)

  • Adverse events

    30 days after inpatient treatment (conservative/surgery)

Interventions

colon surgeryPROCEDURE

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.

Also known as: Subtotal colectomy with ileorectal anastomosis, Diverting loop ileostomy, Colectomy with ileoanal anastomosis, Decompressive cecostomy with periodic antegrade enemas, Segmental colon resection
LaxativesDRUG

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.

Also known as: High-colonic water enema, Water-soluble contrast enema, PEG electrolyte solution, Colon decompression probe, Prucaloprid, Bisacodyl

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Chronic megacolon (colon diameter \> 90 mm)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theresienkrankenhaus und St. Hedwigkliniken GmbH

Mannheim, 68165, Germany

Location

Related Publications (4)

  • 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.

    PMID: 17547862BACKGROUND

  • 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.

    PMID: 25868630BACKGROUND

  • 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.

    PMID: 30953226BACKGROUND

  • 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.

    PMID: 39260392DERIVED

MeSH Terms

Conditions

Megacolon

Interventions

ColectomyLaxativespolyethylene glycol 3350Bisacodyl

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, OperativeGastrointestinal AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesCresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Daniel Schmitz, PhD, MD

    Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 10, 2020

Study Start

May 7, 2020

Primary Completion

December 31, 2021

Study Completion

March 15, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)