Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon

Completed

• Conditions: Megacolon

• Registration Number: NCT04340856
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Study Start: 2020-05-07
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Chronic megacolon (colon diameter > 90 mm)

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Constipation	One year after inpatient treatment (conservative/surgery)	Number of constipation crises leading to further hospital admissions: n

Secondary Outcome Measures

Name	Time	Method
Hospital stay	Three months after inpatient treatment (conservative/surgery)	Hospital stay after inpatient treatment (conservative/surgery): days
Adverse events	30 days after inpatient treatment (conservative/surgery)	Any adverse event after inpatient treatment (conservative/surgery): n

Trial Locations

Locations (1)

Theresienkrankenhaus und St. Hedwigkliniken GmbH; 🇩🇪 Mannheim, Germany