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OpenTrials
Completed

NCT Number: NCT00798863

Study Of The Safety And Efficacy Video Assisted Submandibular Gland Resection Using A New 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University Hospitals

Alexandria, Alexandria Governorate, 110226, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video assisted submandibular sialadenectomy

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.

Other names: video assisted neck surgery

Primary outcomes

  1. incidence of complications after the operation

    Time frame: patients are examined for complications the next day of the operation

Secondary outcomes

  1. operative time

    Time frame: operative time is calculated at the end of the operation

  2. patient satisfaction with the cosmetic result of the operation

    Time frame: 12 weeks after the operation

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Video Assisted Submandibular Resection, Two Step Technique

Acronym: VANSsubmand

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 26, 2008
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.