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Validation of Sodergren Score for Haemorrhoids in Malaysia

U

University of Malaya

Status

Completed

Conditions

Hemorrhoids

Study type

Observational

Funder types

Other

Identifiers

NCT02884076
Sodergren Validation

Details and patient eligibility

About

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

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

500 participants in 1 patient group

Symptomatic Hemorrhoid
Description:
Consecutive patients with symptomatic hemorrhoids presenting to our clinic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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