Role of Methylene Blue in Parotid Surgery

NCT ID: NCT05401370

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Parotid Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MB group

Mb group will undergo surgeries with methylene blue staining

Group Type: ACTIVE_COMPARATOR

Methylene blue dye

Intervention Type: PROCEDURE

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.

Control group

Control group will undergo surgeries without methylene blue staining

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Methylene blue dye

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Cases with secondary tumors of the gland

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ismail Ali Mohamed Ismail

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismail Ali Mohamed

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Central Contacts

Ismail Ali Mohamed

Role: CONTACT

ismailali203040@gmail.com

01124153353

Facility Contacts

Ismail Ali Mohamed

Role: primary

ismailali203040@gmail.com

01124153353

Other Identifiers

MB in parotid surgery

Identifier Type: -

Identifier Source: org_study_id