ThyroidectomyRobot1NCT01075269
Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy
An observational study of Thyroidectomy and Distress, run by Korean Association of Endocrine Surgeons at 1 site in South Korea.
Trial summary
Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroidectomy, Distress, Surgery
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to May 2010
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with differentiated thyroid carcinoma who were scheduled to underwent thyroidectomy in Ajou University Medical center (Tertial oncologic center).
Who may be able to join
- (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or
- (b) a papillary thyroid carcinoma ≤2 cm in diameter.
Who cannot join
- (a) previous neck operations;
- (b) age <21 or >65 years;
- (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy;
- (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or
- (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou University Medical Center, Department of Surgery
Suwon, 443-721
About this study
Official title: Does Robotic Assistance Significantly Reduce Postoperative Distress and Patient Complaints About Cosmetic Outcomes After Thyroid Surgery? A Preliminary Report.
Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed to the conventional anterior, perspective. The wrist action of a surgical robot also provides a greater degree of movement than afforded by the use of simple endoscopic instruments, and tremor is eliminated.
Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of robotic with conventional open thyroidectomy have been described. We therefore designed a prospective trial comparing outcomes, including postoperative distress and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.
Read the detailed description
Patient assessment A prospective study addressing perioperative outcomes and postoperative patient discomfort after thyroidectomy was commenced in April 2009 and is currently continuing. All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. The study protocol was approved by our Institutional Review Board.
Patients were included if they had (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or (b) a papillary thyroid carcinoma ≤2 cm in diameter. Exclusion criteria included (a) previous neck operations; (b) age <21 or >65 years; (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy; (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN). The extent of thyroid resection was determined for each patient using American Thyroid Association guidelines. All patients underwent prophylactic ipsilateral central compartment node dissection (CCND; pretracheal, prelaryngeal, and paraesophageal).
Surgical outcomes Surgical outcomes included operating time, intraoperative blood loss, number of retrieved central lymph nodes, length of hospital stay, and postoperative complications. We also assessed the incidence of postoperative seromas and hematomas for at least 3 weeks postoperatively. Operating time was defined as the interval from skin incision to closure. The drainage extent was measured over 24 h, and a drain was removed if drainage was <30 mL in this interval. Study patients were discharged the day after drain removal.
Mobility of the vocal cords was assessed by videostrobolaryngoscopic examination, performed both preoperatively and 1 week and 3 months postoperatively. Vocal cord palsy was defined as permanent when there was no evidence of recovery within 6 months.
Postoperative pain and cosmetic outcomes To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery.
At 1 week and 3 months after surgery, patients were asked (by questionnaire) to evaluate the presence of hyperesthesia and paresthesia in the neck and anterior chest, as well as shoulder discomfort. All patients answered and returned completed questionnaires.
Cosmetic results, including wound appearance and complaints, were evaluated by patients 3 months after surgery using a verbal response scale with five possible responses: extremely satisfied, excellent, acceptable, dissatisfied, and extremely dissatisfied.
Subjective voice and swallowing evaluation We used the Voice Handicap Index-10 (VHI-10), a validated, reliable self-assessment tool that measures patient assessment of voice quality and the effect of voice on quality-of-life, to determine the frequency of voice abnormalities. The VHI-10 consists of 10 questions, responses to each of which are scaled from a minimum of 0 (no voice alteration) to a maximum of 40 (highest voice impairment).
Swallowing difficulties were assessed using the Swallowing Impairment Index (SIS-6), a self-administered, six-item assessment of symptoms related to dysphagia that has been validated for diagnosis of impairment. The scoring of each item on the SIS-6 ranges from a minimum of 0 (no swallowing alteration) to a maximum of 24 (highest swallowing impairment). The SIS-6 score is also excellent for assessing non-voice throat symptoms, including cough, choking, and throat-clearing, all of which occur after thyroidectomy. All patients enrolled in this study completed the VHI-10 and SIS-6 questionnaires before surgery and at 1 week and 3 months after surgery.
- Conditions
- Thyroidectomy, Distress, Surgery
- Keywords
- robotic thyroidectomy, comparative study, cosmetic result, postoperative neck discomfort, swallowing symptom, Robotic thyroidectomy, cosmetic effect, postoperative distress, surgical outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional open thyroidectomy group | All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. | |
| Robotic thyroidectomy group | All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical outcomes, postoperative pain and cosmetic outcomes
Surgical outcomes included operating time, intraoperative blood loss, length of hospital stay, and postoperative complications.
To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery.
Cosmetic results, including wound appearance and complaints, were evaluated by patients 3 months after surgery using a verbal response scale with five possible responses.
Measured: Postopeative pain: 24 hours after surgery, Cosmetic outcomes: 3 months after surgery
Secondary outcomes (1)
Subjective voice and swallowing evaluation
We used the Voice Handicap Index-10 (VHI-10), a validated, reliable self-assessment tool that measures patient assessment of voice quality and the effect of voice on quality-of-life, to determine the frequency of voice abnormalities.
Swallowing difficulties were assessed using the Swallowing Impairment Index (SIS-6), a self-administered, six-item assessment of symptoms related to dysphagia that has been validated for diagnosis of impairment.
Measured: before surgery and at 1 week and 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Association of Endocrine Surgeons
- Sponsor type
- Research network
- Investigators
- Jandee Lee, MD, Principal investigator, Korean Association of Endocrine Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075269
- Sponsor's protocol ID
- KoreanAES001
- Acronym
- Robot1
- Status last verified
- Feb 2010
- First submitted
- 23 Feb 2010
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Robotic Assistance Significantly Reduce Postoperative Distress and Patient Complaints About Cosmetic Outcomes After Thyroid Surgery? A Preliminary Report.
- ClinicalTrials.gov ID
- NCT01075269
- Acronym / sponsor ID
- Robot1 / KoreanAES001
- Conditions
- Thyroidectomy, Distress, Surgery
- Keywords
- robotic thyroidectomy, comparative study, cosmetic result, postoperative neck discomfort, swallowing symptom, Robotic thyroidectomy, cosmetic effect, postoperative distress, surgical outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Korean Association of Endocrine SurgeonsResearch network
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (estimated)
- First posted
- 25 Feb 2010 (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.
Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed to the conventional anterior, perspective. The wrist action of a surgical robot also provides a greater degree of movement than afforded by the use of simple endoscopic instruments, and tremor is eliminated.
Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of robotic with conventional open thyroidectomy have been described. We therefore designed a prospective trial comparing outcomes, including postoperative distress and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.
Detailed description
Patient assessment A prospective study addressing perioperative outcomes and postoperative patient discomfort after thyroidectomy was commenced in April 2009 and is currently continuing. All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. The study protocol was approved by our Institutional Review Board.
Patients were included if they had (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or (b) a papillary thyroid carcinoma ≤2 cm in diameter. Exclusion criteria included (a) previous neck operations; (b) age <21 or >65 years; (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy; (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN). The extent of thyroid resection was determined for each patient using American Thyroid Association guidelines. All patients underwent prophylactic ipsilateral central compartment node dissection (CCND; pretracheal, prelaryngeal, and paraesophageal).
Surgical outcomes Surgical outcomes included operating time, intraoperative blood loss, number of retrieved central lymph nodes, length of hospital stay, and postoperative complications. We also assessed the incidence of postoperative seromas and hematomas for at least 3 weeks postoperatively. Operating time was defined as the interval from skin incision to closure. The drainage extent was measured over 24 h, and a drain was removed if drainage was <30 mL in this interval. Study patients were discharged the day after drain removal.
Mobility of the vocal cords was assessed by videostrobolaryngoscopic examination, performed both preoperatively and 1 week and 3 months postoperatively. Vocal cord palsy was defined as permanent when there was no evidence of recovery within 6 months.
Postoperative pain and cosmetic outcomes To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery.
At 1 week and 3 months after surgery, patients were asked (by questionnaire) to evaluate the presence of hyperesthesia and paresthesia in the neck and anterior chest, as well as shoulder discomfort. All patients answered and returned completed questionnaires.
Cosmetic results, including wound appearance and complaints, were evaluated by patients 3 months after surgery using a verbal response scale with five possible responses: extremely satisfied, excellent, acceptable, dissatisfied, and extremely dissatisfied.
Subjective voice and swallowing evaluation We used the Voice Handicap Index-10 (VHI-10), a validated, reliable self-assessment tool that measures patient assessment of voice quality and the effect of voice on quality-of-life, to determine the frequency of voice abnormalities. The VHI-10 consists of 10 questions, responses to each of which are scaled from a minimum of 0 (no voice alteration) to a maximum of 40 (highest voice impairment).
Swallowing difficulties were assessed using the Swallowing Impairment Index (SIS-6), a self-administered, six-item assessment of symptoms related to dysphagia that has been validated for diagnosis of impairment. The scoring of each item on the SIS-6 ranges from a minimum of 0 (no swallowing alteration) to a maximum of 24 (highest swallowing impairment). The SIS-6 score is also excellent for assessing non-voice throat symptoms, including cough, choking, and throat-clearing, all of which occur after thyroidectomy. All patients enrolled in this study completed the VHI-10 and SIS-6 questionnaires before surgery and at 1 week and 3 months after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional open thyroidectomy group | – | –All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. |
| Robotic thyroidectomy group | – | –All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with differentiated thyroid carcinoma who were scheduled to underwent thyroidectomy in Ajou University Medical center (Tertial oncologic center).
Key inclusion criteria (2 listed)
- (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or
- (b) a papillary thyroid carcinoma ≤2 cm in diameter.
Key exclusion criteria (5 listed)
- (a) previous neck operations;
- (b) age <21 or >65 years;
- (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy;
- (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or
- (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical outcomes, postoperative pain and cosmetic outcomes
Time frame: Postopeative pain: 24 hours after surgery, Cosmetic outcomes: 3 months after surgery
Surgical outcomes included operating time, intraoperative blood loss, length of hospital stay, and postoperative complications. To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery. Cosmetic results, including wound appearance and complaints, were evaluated by patients 3 months after surgery using a verbal response scale with five possible responses.
1 secondary outcome
Subjective voice and swallowing evaluation
Time frame: before surgery and at 1 week and 3 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
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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.
Jandee Lee, MD principal investigator
Korean Association of Endocrine Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroidectomy and Distress, run by Korean Association of Endocrine Surgeons 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Feb 2010. 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?
Results are not available in the source record.
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?
Surgical outcomes, postoperative pain and cosmetic outcomes (time frame: Postopeative pain: 24 hours after surgery, Cosmetic outcomes: 3 months after surgery). 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 25 Feb 2010.