NCT01604720

Brief Summary

Sample size definition provides important information, allowing the groundwork for transparent reporting. The sample predefinition allows the trial to be large enough to be able to address the question that is being asked. The aim of the present study is to assess, in all the randomized controlled trials (RCT) included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of reporting sample size the accuracy of the calculations, the accuracy of the a priori assumptions and the effect on the agreement with pooled results in meta-analyses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 14, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

3.4 years

First QC Date

May 14, 2012

Last Update Submit

January 13, 2015

Conditions

Definition of Sample Size in Randomized Clinical Trial Assessing Liver Disease

Keywords

sample sizeliver disease

Outcome Measures

Primary Outcomes (1)

  • proportion of reported sample size definitions

    number of included studies with explicit sample size definition/ number of included studies

    up to three months after retrievement and inclusion of all studies

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Randomized clinical trials included in systematic reviews of the hepato-biliary Group of the Cochrane Collaboration

You may qualify if:

  • Two arms, parallel group superiority randomised controlled trials with a single primary outcome,

You may not qualify if:

  • Reports for which the study design was factorial, cluster, or crossover

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine Department A.Manzoni Hospital

Lecco, I 23900, Italy

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • agostino colli, MD

    AO provincia di lecco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

agostino colli, MD

CONTACT

+390341489670a.colli@ospedale.lecco.it

giovanni casazza, PhD

CONTACT

+390250319653giovanni.casazza@unimi.it

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Internal Medicine Department AO provincia di Lecco

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 24, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

IT(1)