SMG Resection in Comparison to Endoscopic SMG Resection
Conditions
Keywords
submandibular gland, robotic, endoscopic, face lift, hairline
Brief summary
Traditional transcervical incision of the upper neck is a safe and effective approach for resection of the submandibular gland (SMG). However, external scar at the highly visible area may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted' and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes since the scar was hidden by the auricle and hair. In our previous feasibility study of robot-assisted SMG resection, the investigators proposed that robot-assisted technique may overcome the limitations of endoscopic instruments with rigid and straight nature without articulation and surgical view of two-dimension. In addition, the ergonomically designed operating system was more convenient for the surgeon considering the frequent collision of the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery. However, clinical trial comparing the surgical outcomes of the two techniques has not been reported in the literature. In this study, the investigators made a prospective comparative study of robot-assisted versus endoscope-assisted SMG resection to determine whether robot-assisted technique has benefits regarding early surgical outcomes.
Interventions
DEVICERobotic SMG resection
The surgical procedure and the considerations for surrounding neurovascular structures were similar to that of the endoscope-assisted SMG resection. The da Vinci surgical system (Intuitive Surgical Inc., Sunnyvale, CA) including a 30° dual channel endoscopic arm and two instrument arms was introduced. The SMG was retracted using the 5-mm Maryland forceps on the left and the dissection was conducted using a 5-mm spatula monopolar cautery or a Harmonic curved shears on the right. A Yankauer suction handled by a bed-side assistant could be used for counter traction of the gland which facilitated the dissection procedure.
DEVICEEndoscopic SMG resection
An assistant held a 10-mm 30° rigid endoscope allowing the operating surgeon to use both hands. Surgical resection tools such as dissector and Harmonic scalpel (Harmonic Ace 23E®; Johnson & Johnson Medical, Cincinnati, OH, USA) was held in the right hand and a Yankauer suction or a Debakey forcep was held on the left for traction of the SMG. The dissection plane between the capsule of the SMG was conducted under magnified endoscopic view using the the blade of the Harmonic scalpel and the endoscopic dissector. Routine identification of the marginal mandibular branch of the facial nerve was unnecessary in SMG resection, since the dissection plane was always deep to the middle layer of the deep cervical fascia which includes the fascia of the gland. The Wharton's duct, facial artery and vein were ligated using the Harmonic scalpel or vascular clip.
Sponsors
Yonsei University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB)
Exclusion criteria
* Past history of neck surgery or radiation * Possible malignancy expected from FNAB or image study * Gland with severe adhesion to surrounding tissue on preoperative physical examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of incision | expected average opeartion time : 60~90 minutes | length of incision is measure by a surgical ruler after before skin incision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| amount and duration of drainage | on the day of discharge from hospital (expected average period : postoperative 3 days) | duration of drainage, hospital stay and complications are measured on the day of discharge by the charge doctor |
| hospital stay | on the day of discharge from hospital (expected average period : postoperative 3 days) | — |
| complications | on the day of discharge from hospital (expected average period : postoperative 3 days) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| size of the tumor and SMG | expected average time : 1 week after surgery | size of the tumor and SMG is measure by the pathologist |
| cosmetic satisfaction score | 2 months after surgery | cosmetic satisfaction score is evaluated at the out-patient department during follow up using the questionnaire with scale of 1 (extremely dissatisfied) to 5 (extremely satisfied) |
Countries
South Korea
Outcome results
None listed