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

University of Alexandria

Status: Completed

Conditions: Submandibular Gland Resection

Treatments: Procedure: video assisted submandibular sialadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00798863

VASS

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

operative group

Experimental group

Description:

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

Treatment:

Procedure: video assisted submandibular sialadenectomy