Validation of Sodergren Score for Haemorrhoids in Malaysia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02884076

Enrollment

500

Registered

2016-08-30

Start date

2017-01-31

Completion date

2019-05-31

Last updated

2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids

Keywords

Hemorrhoids, Sodergren score, Validation

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Method of treatment	12 months	Surgery or ambulatory treatment of hemorrhoid

Countries

Malaysia

Outcome results