Validation of Sodergren Score for Haemorrhoids in Malaysia | NCT02884076

Studies
Validation of Sodergren Score for Haemorrhoids in Malaysia

NCT02884076

Sponsor

University of Malaya

Status

Completed

Last Update Posted

May 29, 2019Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Hemorrhoids

Interventions

Not provided

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

May 2019Actual

Completion Date

May 2019Actual

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Aug 25, 2016

First Posted Date

Aug 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2019

Last Update Posted Date

May 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symptomatic Hemorrhoid		Consecutive patients with symptomatic hemorrhoids presenting to our clinic

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Method of treatment	Surgery or ambulatory treatment of hemorrhoid	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients at specialist clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hon Leong Sha, MD	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HRPB		Ipoh	Perak	30450	Malaysia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25603811	Background	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.

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases