Validation of Sodergren Score for Haemorrhoids in Malaysia

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884076
• Other study ID #: Sodergren Validation
• Status: Completed
• Start date: January 2017
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Locations

Country	Name	City	State
Malaysia	HRPB	Ipoh	Perak

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Method of treatment	Surgery or ambulatory treatment of hemorrhoid	12 months