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

July 14, 2009 updated by: University of Alexandria

Video Assisted Submandibular Resection, Two Step Technique

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 110226
        • Alexandria University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: operative group
The patients of the group will have the operation of two step video assisted submandibular sialadenectomy.
Procedure: 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.
Other Names:
  • video assisted neck surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of complications after the operation
Time Frame: patients are examined for complications the next day of the operation
patients are examined for complications the next day of the operation

Secondary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: operative time is calculated at the end of the operation
operative time is calculated at the end of the operation
patient satisfaction with the cosmetic result of the operation
Time Frame: 12 weeks after the operation
12 weeks after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Investigators

  • Principal Investigator: Yasser Hamza, A professor, University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VASS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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