Patients With Hemorrhoids Referred to a Surgical Specialist Department

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Ersta Hospital, Sweden

Information provided by (Responsible Party):

Solveig Elmér, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT01706601

First received: October 11, 2012

Last updated: March 9, 2015

Last verified: March 2015

History of Changes

Purpose

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.

Condition
Hemorrhoids


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Patients With Hemorrhoids Referred to a Surgical Specialist Department

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

Correct diagnosis? [ Time Frame: patients visiting Ersta Hospital between 2007-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

treatment of hemorrhoids [ Time Frame: patients visiting Ersta Hospital between 2007-2009 ] [ Designated as safety issue: No ]
Surgical or conservative treatment, results and number of patients in the groups

Other Outcome Measures:

Examination/treatment [ Time Frame: Before visiting Ersta hospital ] [ Designated as safety issue: No ]
Examination and treatment given by general practitioner
Operation/complication [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
Which operations were performed, complications?, reinterventions?
genus [ Time Frame: between 2007-2009 ] [ Designated as safety issue: No ]
Did men and women got the same treatment
Treated elsewhere [ Time Frame: after compleated treatment at Ersta hospital ] [ Designated as safety issue: No ]


Estimated Enrollment:	800
Study Start Date:	February 2011
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
Hemorrhoids Patient with hemorrhoids

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients whith hemorrhoids

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706601

Locations


Sweden
Ersta hospital
Stockholm, Sweden, 116 91

Sponsors and Collaborators

Karolinska Institutet

Ersta Hospital, Sweden

Investigators


Principal Investigator:	Solveig Elmér, MD	Karolinska Institutet

More Information


Responsible Party:	Solveig Elmér, MD, Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT01706601 History of Changes
Other Study ID Numbers:	2010/1108-31/1
Study First Received:	October 11, 2012
Last Updated:	March 9, 2015
Health Authority:	Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:


Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases	Digestive System Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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