SMG Resection in Comparison to Endoscopic SMG ResectionNCT01726907
A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach
A study testing Robotic SMG resection and Endoscopic SMG resection in people with SMG Resection in Comparison to Endoscopic SMG Resection, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- SMG Resection in Comparison to Endoscopic SMG Resection
- What is being tested?
- Robotic SMG resection and Endoscopic SMG resection
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
epartment of Otorhinolaryngology, Yonsei University College of Medicine
Seoul, 120-752
About this study
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.
- Being tested
- Robotic SMG resection, Endoscopic SMG resection
- Keywords
- submandibular gland, robotic, endoscopic, face lift, hairline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic SMG resectionDevice
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.
Endoscopic SMG resectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic SMG resection | Experimental | Robot-assisted SMG resection Receives: Device: Robotic SMG resection |
| Endoscopic SMG resection | Active comparator | Endoscope-assisted SMG resection Receives: Device: Endoscopic SMG resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of incision
length of incision is measure by a surgical ruler after before skin incision
Measured: expected average opeartion time : 60~90 minutes
Secondary outcomes (3)
amount and duration of drainage
duration of drainage, hospital stay and complications are measured on the day of discharge by the charge doctor
Measured: on the day of discharge from hospital (expected average period : postoperative 3 days)
hospital stay
Measured: on the day of discharge from hospital (expected average period : postoperative 3 days)
complications
Measured: on the day of discharge from hospital (expected average period : postoperative 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Why it stopped: Stopped due to failure to recruit appropriate target patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SMG Resection in Comparison to Endoscopic SMG ResectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726907
- Sponsor's protocol ID
- 4-2011-0819
- Status last verified
- May 2021
- First submitted
- 7 Nov 2012
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach
- ClinicalTrials.gov ID
- NCT01726907
- Acronym / sponsor ID
- 4-2011-0819
- Keywords
- submandibular gland, robotic, endoscopic, face lift, hairline
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped due to failure to recruit appropriate target patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic SMG resection | Experimental | Device: Robotic SMG resectionRobot-assisted SMG resection |
| Endoscopic SMG resection | Active comparator | Device: Endoscopic SMG resectionEndoscope-assisted SMG resection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic SMG resectionThe 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. | Device | Robotic SMG resection |
| Endoscopic SMG resectionAn 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. | Device | Endoscopic SMG resection |
Primary outcome
length of incision
Time frame: expected average opeartion time : 60~90 minutes
length of incision is measure by a surgical ruler after before skin incision
3 secondary outcomes
amount and duration of drainage
Time frame: on the day of discharge from hospital (expected average period : postoperative 3 days)
hospital stay
Time frame: on the day of discharge from hospital (expected average period : postoperative 3 days)
complications
Time frame: on the day of discharge from hospital (expected average period : postoperative 3 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic SMG resection and Endoscopic SMG resection in people with SMG Resection in Comparison to Endoscopic SMG Resection, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of incision (time frame: expected average opeartion time : 60~90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.