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Patients With Hemorrhoids Referred to a Surgical Specialist Department

This study is currently recruiting participants.
Verified October 2012 by Karolinska Institutet
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: October 12, 2012
Last verified: October 2012
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: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemorrhoids
Patient with hemorrhoids

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706601

Contacts
Contact: Solveig Elmér, MD +46 (8) 0 714 6422 ext 6422 solveig.elmer@erstadiakoni.se
Contact: Claes Lenander, MD, PhD +46 (8) 0 714 6213 ext 6213 claes.lenander@erstadiakoni.se

Locations
Sweden
Ersta hospital Recruiting
Stockholm, Sweden, 116 91
Contact: Solveig Elmer, MD     +46 (0) 8 714 6422     solveig.elmer@erstadiakoni.se    
Contact: Claes Lenander, MD, PhD     +46 (0) 8 714 6243     claes.lenender@erstadiakoni.se    
Sub-Investigator: Jonas Nygren, Assoc Prof            
Sponsors and Collaborators
Karolinska Institutet
Ersta Hospital, Sweden
Investigators
Principal Investigator: Solveig Elmér, MD Karolinska Institutet
  More Information

No publications provided

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: October 12, 2012
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 May 19, 2013