Association of Lunar Phases With Post-surgical Morbidity | NCT00982683

Studies
Association of Lunar Phases With Post-surgical Morbidity

NCT00982683

Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Status

Completed

Last Update Posted

Sep 23, 2009Estimated

Enrollment

26,244Actual

Phase

Not provided

Conditions

Hemorrhage

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998

Primary Completion Date

May 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 22, 2009

First Submission Date that Met QC Criteria

Sep 22, 2009

First Posted Date

Sep 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2009

Last Update Posted Date

Sep 23, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyOTHER

Collaborators

Name	Class
University of Genova	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The potential influence of lunar phases on human life has been widely discussed by the lay press. The purpose of this study was to evaluate a possible relation between the lunar cycle and the hemorrhagic complication rate and surgical outcome.

PATIENTS AND METHODS:

The investigators tested this hypothesis by evaluating the complication rate for 18760 patients who underwent surgery from January 2001 to December 2008 (103 lunar phases) at the National Institute for Cancer Research in Genoa.

The date of definitive surgery was allocated to the lunar phases.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26,244Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dependence analysis between post-surgical complications and lunar phases.		2001 - 2008

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

None

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients operated at the National Cancer Institute, Genoa, Italy, during the period 2001-2008

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edoardo Raposio, MD	National Cancer Institute, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute, Italy		Genova		16132	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2517088	Background	Sha LR, Xu NT, Song XH, Zhang LP, Zhang Y. Lunar phases, myocardial infarction and hemorrheological character. A Western medical study combined with appraisal of the related traditional Chinese medical theory. Chin Med J (Engl). 1989 Sep;102(9):722-5.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms