NCT04255667

Brief Summary

Surgery involves eyelid margin asscocited with intraoperative bleeding. Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

February 3, 2020

Last Update Submit

January 26, 2021

Conditions

Eyelid Diseases

Keywords

eyelid marginhemostasis

Outcome Measures

Primary Outcomes (1)

  • amount of intraoperative bleeding

    bleeding is recorded by photography

    intraoperative

Secondary Outcomes (1)

  • time of operation

    intraoperative

Study Arms (2)

Study group

Eyelid surgery involving eyelid margin is done after eyelid margin crushing with hemostat at start of surgery

Procedure: Eyelid margin crush

Control group

Eyelid surgery involving eyelid margin is done after eyelid margin crushing without hemostat

Procedure: Eyelid margin crush

Interventions

Eyelid margin crushPROCEDURE

after marking eyelid , hemostat is used for eyelid margin incision crush . Then eyelid surgery is done

Control groupStudy group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 patient with marginal eyelid diseases surgeries will undergo surgeries

You may qualify if:

  • All surgeries involving eyelid margin

You may not qualify if:

  • bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, 46266, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Eyelid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • TAREK R ELHAMAKY, MD

    Benha university faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TAREK R ELHAMAKY, MD

CONTACT

+971503207889dr_thamakyy@yahoo.com

TAREK R ELHAMAKY

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

January 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 15, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)