Study Of The Safety And Efficacy Video Assisted Submandibular Gland Resection Using A New Two Step Technique

NCT ID: NCT00798863

Last Updated: 2009-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-05-31

Brief Summary

The study addresses a problem that face surgeons who perform key-hole surgery to resect the submandibular salivary gland. The problem is the narrow space available around that gland. This does not allow for a safe operation. The study aims to evaluate a new, two step resection technique, that should overcome this difficulty.

Detailed Description

The study included twelve adult patients suffering from chronic submandibular sialadenitis and indicated for sialadenectomy. The following exclusion criteria were adopted: Previous history of surgery or irradiation to the neck; History of abscess formation in the region; Patients having large, hard or fixed submandibular gland and where there was suspicion of malignancy. Laboratory work-up and ultrasound of the neck were obtained.All patients had video assisted submandibular sialadenectomy, using a "two step resection" technique as follows:Step 1: A 15 to 20 mm skin incision was performedThe edges of the wound are protected using a rubber cuff. The dissection is done using the harmonic scalpel in one hand and the suction spatula in the other hand. The anterior part of the gland is then dissected off the mylohyoid muscle. The plane of the dissected anterior pole of the gland is used as a guide. This plane is followed all around the gland until the whole superficial part of the gland is dissected free. Step 2: The retractors are adjusted to elevate the roof of the cavity created by removing the superficial part pf the gland. The scope is inserted into the wound to view the deeper part of the operative field. All nearby important structures are now identified and protected. The deep part of the gland is dissected and removed

Conditions

Submandibular Gland Resection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

operative group

The patients of the group will have the operation of two step video assisted submandibular sialadenectomy.

Group Type: EXPERIMENTAL

video assisted submandibular sialadenectomy

Intervention Type: PROCEDURE

Step 1: A 15 to 20 mm skin incision is performed. The anterior part of the gland is then dissected off the mylohyoid muscle. The superficial part of the gland is dissected free. Now, the free superficial part of the gland is resected .Step 2: The scope is inserted into the wound to view the deeper part of the gland. The latter is dissected and removed after identifying the tendon of the digastric muscle, the hypoglossal nerve, the lingual nerve and the submandibular duct. The lingual nerve is released from its attachment to the gland. The submandibular duct is ligated using 3/0 vicryl. The deep part of the gland is extracted through the wound. Hemostasis is secured.

Interventions

video assisted submandibular sialadenectomy

Step 1: A 15 to 20 mm skin incision is performed. The anterior part of the gland is then dissected off the mylohyoid muscle. The superficial part of the gland is dissected free. Now, the free superficial part of the gland is resected .Step 2: The scope is inserted into the wound to view the deeper part of the gland. The latter is dissected and removed after identifying the tendon of the digastric muscle, the hypoglossal nerve, the lingual nerve and the submandibular duct. The lingual nerve is released from its attachment to the gland. The submandibular duct is ligated using 3/0 vicryl. The deep part of the gland is extracted through the wound. Hemostasis is secured.

Intervention Type: PROCEDURE

Other Intervention Names

video assisted neck surgery

Eligibility Criteria

Inclusion Criteria

• Adult patient
• Has submandibular sialadenitis

Exclusion Criteria

• Previous history of surgery or irradiation to the neck
• History of abscess formation in the region
• Patients having large, hard or fixed submandibular gland
• If there was suspicion of malignant submandibular tumour

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alexandria

OTHER

Sponsor Role: lead

Responsible Party

UAlexandria

Principal Investigators

Yasser Hamza, A professor

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

Alexandria University Hospitals

Alexandria, Alexandria Governorate, Egypt

Countries

Egypt

Other Identifiers

VASS

Identifier Type: -

Identifier Source: org_study_id