Patients With Hemorrhoids Referred to a Surgical Speciali... | NCT01706601

Studies
Patients With Hemorrhoids Referred to a Surgical Specialist Department

NCT01706601

Sponsor

Karolinska Institutet

Status

Unknown status

Last Update Posted

Mar 10, 2015Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Hemorrhoids

Interventions

Not provided

Countries

Sweden

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Oct 11, 2012

First Submission Date that Met QC Criteria

Oct 12, 2012

First Posted Date

Oct 15, 2012Estimated

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

Mar 9, 2015

Last Update Posted Date

Mar 10, 2015Estimated

Name	Class
Ersta Hospital, Sweden	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

Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population. This means that many patients are referred to surgical specialist reception with diagnosis hemorrhoidal disease. The aim of this study is to describe population of patients with hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what treatment they are given at a general practitioner as well as in colorectal unit.

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

800Estimated

Label	Type	Description	Intervention Names
Hemorrhoids		Patient with hemorrhoids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correct diagnosis?		patients visiting Ersta Hospital between 2007-2009

Secondary Outcomes

Measure	Description	Time Frame
treatment of hemorrhoids	Surgical or conservative treatment, results and number of patients in the groups	patients visiting Ersta Hospital between 2007-2009

Other Outcomes

Measure	Description	Time Frame
Examination/treatment	Examination and treatment given by general practitioner	Before visiting Ersta hospital
Operation/complication	Which operations were performed, complications?, reinterventions?

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with diagnosis hemorrhoidal disease that are referred to a surgical specialist department

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients whith hemorrhoids

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Solveig Elmér, MD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ersta hospital		Stockholm		116 91	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided