Diagnostic Outcomes of Patients Presenting With Per Recta... | NCT03594942

Studies
Diagnostic Outcomes of Patients Presenting With Per Rectal Bleed in Surgical Departments of Services Hospital Lahore

NCT03594942

Sponsor

Services Hospital, Lahore

Status

Unknown status

Last Update Posted

Jul 20, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Rectal Bleeding

Interventions

procto sigmoidoscopy and biopsy if required

Countries

Pakistan

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Aug 1, 2018Estimated

Completion Date

Aug 1, 2018Estimated

First Submitted Date

Jul 8, 2018

First Submission Date that Met QC Criteria

Jul 19, 2018

First Posted Date

Jul 20, 2018Actual

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

Jul 19, 2018

Last Update Posted Date

Jul 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. SamiUllah, Principle investigator, Services Hospital, LahorePrincipal Investigator

Lead Sponsor

Services Hospital, LahoreOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

It is a cross sectional study in which investigators will be recruiting patients of any sex above 12 years of age who will present to surgical outdoor with per rectal bleed. Investigators will then follow them through investigations to reach a certain diagnosis. Then investigators will be able to compile the data of diseases and their frequency, which are presenting with rectal bleed in their setup.

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
procto sigmoidoscopy and biopsy if required	Diagnostic Test	procto sigmoidoscopy of patients presenting with per rectal bleed will be carried out to locate the source of bleeding and biopsy if required.		colonoscopy, puch biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of diseases in patients with rectal bleed	outcome of this study is to discover the frequency of diseases which are presenting with rectal bleed in our setup like hemorrhoids, anal fissure or rectal carcinoma	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient of any sex above 12 years old
patients with rectal bleed in OPD

Exclusion Criteria:

Patient with acute rectal bleeding due to infection like dysentry
Acute proctitis
Acute colitis

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patintes will be from lahore city and adjacent areas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shabbar h changazi, mbbs, fcps	Contact	+9203129700111		shabbarchangazi246@gmail.com

Overall Officials

Name	Affiliation	Role
Mahmmood Ayyaz, mbbs, fcps	Services Hospital, Lahore	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Services hospital	Recruiting	Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006471	Gastrointestinal Hemorrhage

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003113	Colonoscopy

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided