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Role of Methylene Blue in Parotid Surgery

Primary Purpose

Parotid Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Methylene blue dye
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parotid Tumor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All new cases presented with primary benign or malignant parotid tumors.

Exclusion Criteria:

  • Cases with secondary tumors of the gland

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

MB group

Control group

Arm Description

Mb group will undergo surgeries with methylene blue staining

Control group will undergo surgeries without methylene blue staining

Outcomes

Primary Outcome Measures

Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye.
Twenty cases presented to outpatient clinic in Assiut university hospital with benign or primary malignant parotid gland tumors will be included in the study, clinically evaluated, confirmation of diagnosis will be achieved by CT, MRI, or CT/MRI investigations , ultrasonography and fine-needle aspiration biopsy (FNAB). then Divide the selected cases into two groups randomly; group A for surgeries with MB staining and group B for surgeries without MB staining that serves as control group. type of surgery will be chosen according to CT or MRI data and fine-needle aspiration biopsy (FNAB)then Follow up facial nerve injury manifestations for the included cases for one year for comparison between 2 groups

Secondary Outcome Measures

Full Information

First Posted
April 25, 2022
Last Updated
June 1, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05401370
Brief Title
Role of Methylene Blue in Parotid Surgery
Official Title
Role of Methylene Blue Dye in Identification of Facial Nerve in Parotid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery
Detailed Description
The specific surgical morbidity remains significant in parotid gland surgery. In addition to temporary facial weakness and permanent facial nerve injury, postparotidectomy depression and Frey's syndrome (gustatory sweating) are specific for this type of surgery. To reduce the surgical morbidity, several modifications of parotidectomy have been implemented but postsurgical complications remain especially facial nerve injury . To overcome this difficulty, an identification method might be used such as preoperative intravital staining of the gland with methylene blue (MB). Although MB staining is not designed to be used as a sole technique, it can be combined with other techniques such as identification of the anatomic landmarks. MB staining is simple, inexpensive, and not time consuming technique.It is an indirect facial nerve identification technique, because there is no nerve handling,thus decreasing iatrogenic nerve impairment.After injection of the parotid gland with MB dye, fine white nerve fibers can be observed . Tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parotid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MB group
Arm Type
Active Comparator
Arm Description
Mb group will undergo surgeries with methylene blue staining
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will undergo surgeries without methylene blue staining
Intervention Type
Procedure
Intervention Name(s)
Methylene blue dye
Intervention Description
For MB group, the staining of the glandular tissue will be obtained with 3-4 mL of 1% MB that will be introduced into the gland via the salivary duct several minutes before the surgery.The trans-oral catheterization of the Stensen's duct will be performed and the solution will be injected via intravenous cannula.The glandular tissue will turn dark blue.
Primary Outcome Measure Information:
Title
Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye.
Description
Twenty cases presented to outpatient clinic in Assiut university hospital with benign or primary malignant parotid gland tumors will be included in the study, clinically evaluated, confirmation of diagnosis will be achieved by CT, MRI, or CT/MRI investigations , ultrasonography and fine-needle aspiration biopsy (FNAB). then Divide the selected cases into two groups randomly; group A for surgeries with MB staining and group B for surgeries without MB staining that serves as control group. type of surgery will be chosen according to CT or MRI data and fine-needle aspiration biopsy (FNAB)then Follow up facial nerve injury manifestations for the included cases for one year for comparison between 2 groups
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All new cases presented with primary benign or malignant parotid tumors. Exclusion Criteria: Cases with secondary tumors of the gland
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail Ali Mohamed
Phone
01124153353
Email
ismailali203040@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Ali Mohamed
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismail Ali Mohamed
Phone
01124153353
Email
ismailali203040@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Age,sex,clinical diagnosis.
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
Age,sex,clinical diagnosis.

Learn more about this trial

Role of Methylene Blue in Parotid Surgery

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