Validation of Sodergren Score for Haemorrhoids in Malaysia

Completed

• Conditions: Hemorrhoids

• Registration Number: NCT02884076
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Study Start: 2017-01
• Status Verified: 2019-05
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-05-26
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Method of treatment	12 months	Surgery or ambulatory treatment of hemorrhoid

Trial Locations

Locations (1)

HRPB; 🇲🇾 Ipoh, Perak, Malaysia