NCT02884076

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

2.3 years

First QC Date

August 22, 2016

Last Update Submit

May 26, 2019

Conditions

Hemorrhoids

Keywords

HemorrhoidsSodergren scoreValidation

Outcome Measures

Primary Outcomes (1)

  • Method of treatment

    Surgery or ambulatory treatment of hemorrhoid

    12 months

Study Arms (1)

Symptomatic Hemorrhoid

Consecutive patients with symptomatic hemorrhoids presenting to our clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients at specialist clinics

You may qualify if:

  • years of age and older
  • Male and female genders
  • Previous ambulatory treatment
  • Internal Haemorrhoids

You may not qualify if:

  • Presence of external haemorrhoids
  • Prior haemorrhoidal surgery
  • Anti-coagulant therapy
  • Anal fissure
  • Inflammatory bowel disease
  • Underlying colon-rectal malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HRPB

Ipoh, Perak, 30450, Malaysia

Location

Related 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.

    PMID: 25603811BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hon Leong Sha, MD

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 30, 2016

Study Start

January 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)