Validation of Sodergren Score for Haemorrhoids in Malaysia

NCT ID: NCT02884076

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hemorrhoids

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic Hemorrhoid

Consecutive patients with symptomatic hemorrhoids presenting to our clinic

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Galen Sha

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hon Leong Sha, MD

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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HRPB

Ipoh, Perak, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 25603811 (View on PubMed)

Other Identifiers

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Sodergren Validation

Identifier Type: -

Identifier Source: org_study_id

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