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OpenTrials
Completed

NCT Number: NCT02884076

Validation of Sodergren Score for Haemorrhoids in Malaysia

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HRPB

Ipoh, Perak, 30450, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Method of treatment

    Time frame: 12 months

    Surgery or ambulatory treatment of hemorrhoid

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Validating the Ability of the Sodergren Score to Guide Management of Symptomatic Haemorrhoids in a Malaysian Population

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2016
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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