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Validation of Sodergren Score for Haemorrhoids in Malaysia

This study is currently recruiting participants.
Verified January 2017 by Galen Sha, University of Malaya
Sponsor:
ClinicalTrials.gov Identifier:
NCT02884076
First Posted: August 30, 2016
Last Update Posted: January 18, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Galen Sha, University of Malaya
  Purpose
To validate the ability of the Sodergren score in guiding the management of symptomatic haemorrhoids in a Malaysian population.

Condition
Hemorrhoids

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Galen Sha, University of Malaya:

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


Estimated Enrollment: 500
Study Start Date: January 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Symptomatic Hemorrhoid
Consecutive patients with symptomatic hemorrhoids presenting to our clinic

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Hon Leong Sha, MD +60123073618 gal3nsha@gmail.com

Locations
Malaysia
HRPB Recruiting
Ipoh, Perak, Malaysia, 30450
Contact: Hon Leong Sha, MD    +60123073618    gal3nsha@gmail.com   
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: Hon Leong Sha, MD University of Malaya
  More Information

Publications:
Responsible Party: Galen Sha, Dr, University of Malaya
ClinicalTrials.gov Identifier: NCT02884076     History of Changes
Other Study ID Numbers: Sodergren Validation
First Submitted: August 22, 2016
First Posted: August 30, 2016
Last Update Posted: January 18, 2017
Last Verified: January 2017
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:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases