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Validation of Sodergren Score for Haemorrhoids in Malaysia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02884076
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Galen Sha, University of Malaya

Brief Summary:
To validate the ability of the Sodergren score in guiding the management of symptomatic haemorrhoids in a Malaysian population.

Condition or disease
Hemorrhoids

Detailed Description:
All participating, consented subjects will be scored with the Sodergren score prior to receiving a standardized ambulatory treatment regime. The questionnaire will be self-administered by the subjects. Subjects whom are not able to self-administer the questionnaire will be assisted by the investigator or research assistant. The nature and severity of the subject's haemorrhoidal symptoms are considered as the pre-treatment baseline. A follow up period of 12 months will be carried out post treatment for failure or success of treatment. The data collected will be compared to pre-treatment scores and analyzed statistically.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validating the Ability of the Sodergren Score to Guide Management of Symptomatic Haemorrhoids in a Malaysian Population
Actual Study Start Date : January 2017
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Group/Cohort
Symptomatic Hemorrhoid
Consecutive patients with symptomatic hemorrhoids presenting to our clinic



Primary Outcome Measures :
  1. Method of treatment [ Time Frame: 12 months ]
    Surgery or ambulatory treatment of hemorrhoid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients at specialist clinics
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Male and female genders
  • Previous ambulatory treatment
  • Internal Haemorrhoids

Exclusion Criteria:

  • Presence of external haemorrhoids
  • Prior haemorrhoidal surgery
  • Anti-coagulant therapy
  • Anal fissure
  • Inflammatory bowel disease
  • Underlying colon-rectal malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884076


Locations
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Malaysia
HRPB
Ipoh, Perak, Malaysia, 30450
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Hon Leong Sha, MD University of Malaya

Publications:
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Responsible Party: Galen Sha, Dr, University of Malaya
ClinicalTrials.gov Identifier: NCT02884076    
Other Study ID Numbers: Sodergren Validation
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galen Sha, University of Malaya:
Hemorrhoids
Sodergren score
Validation
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases