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

Not Applicable

Completed

• Conditions: Submandibular Gland Resection
• Interventions: Procedure: video assisted submandibular sialadenectomy

• Registration Number: NCT00798863
• Lead Sponsor: University of Alexandria

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

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
operative group	video assisted submandibular sialadenectomy	The patients of the group will have the operation of two step video assisted submandibular sialadenectomy.

Primary Outcome Measures

Name	Time	Method
incidence of complications after the operation	patients are examined for complications the next day of the operation

Secondary Outcome Measures

Name	Time	Method
operative time	operative time is calculated at the end of the operation
patient satisfaction with the cosmetic result of the operation	12 weeks after the operation

Trial Locations

Locations (1)

Alexandria University Hospitals; 🇪🇬 Alexandria, Egypt