Trials / Completed
CompletedNCT00798863
Study Of The Safety And Efficacy Video Assisted Submandibular Gland Resection Using A New Two Step Technique
Video Assisted Submandibular Resection, Two Step Technique
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Alexandria · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2008-11-26
- Last updated
- 2009-07-15
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT00798863. Inclusion in this directory is not an endorsement.