Clinical trial NCT00798863: Study Of The Safety And Efficacy Video Assisted Submandibular Gland Resection Using A New Two Step Technique
Official title: Video Assisted Submandibular Resection, Two Step Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Submandibular Gland Resection
Keywords: submandibular gland
video assisted neck surgery
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: incidence of complications after the operation
timeFrame: patients are examined for complications the next day of the operation
Secondary outcomes:
measure: operative time
timeFrame: operative time is calculated at the end of the operation
measure: patient satisfaction with the cosmetic result of the operation
timeFrame: 12 weeks after the operation
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Hospitals
Study officials:
affiliation: University of Alexandria
name: Yasser Hamza, A professor
role: PRINCIPAL_INVESTIGATOR
References: