Intraoperative Mitomycin C in Lacrimal Sac Mucocele

June 1, 2017 updated by: Mohamed Farag Khalil Ibrahiem, Minia University

Evaluation of Intraoperative Mitomycin C in Surgical Management of Lacrimal Sac Mucocele

30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lacrimal sac mucocele

Exclusion Criteria:

  • Paediatric patients (less than 16 years old).
  • Previous lacrimal passage procedure.
  • Neoplasms as secondary causes of obstruction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Chronic dacryocystitis patients
Procedure: Canaliculo- Dacryocystorhinostomy
Bypass lacrimal passage obstruction by opening a shunt between the lacrimal sac and the nasal mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disappearance of lacrimal sac swelling
Time Frame: 1 month
No evident swelling in the medial side of the eye
1 month
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
Time Frame: 1 month
Patency of the lacrimal passage
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2011

Primary Completion (ACTUAL)

January 7, 2012

Study Completion (ACTUAL)

January 7, 2013

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (ACTUAL)

June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minia Hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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