Papillary Thyroid CarcinomaNCT01311089
A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy
An observational study of Papillary Thyroid Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Papillary Thyroid Carcinoma
- How many people
- 169 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Sep 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 patients with papillary thyroid carcinoma who underwent thyroidectomy at Yonsei University Health System were enrolled. 60patients were conventional open thyroidectomy group and 60 patients were robotic thyroidectomy group. All of these patients was over 20 years old.
Who may be able to join
- Patients with papillary thyroid carcinoma who underwent thyroidectomy
- Age was over 20 years old
Who cannot join
- Keloid
- Previous neck or anterior chest operation history
- The patients who underwent combined radical neck dissection
- The patient with postoperative wound problem
- The patient with underlying systemic disease which can make influences on the wound healing process
- The patient who can not read and understand the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy : Postoperative Body Image Change and Cosmetic Satisfaction
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction.
Read the detailed description
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. In this study, we designed a prospective study comparing the cosmetic satisfaction and the postoperative body image change which associated with patient self-esteem between robotic thyroidectomy and conventional open thyroidectomy group.
- Conditions
- Papillary Thyroid Carcinoma
- Medical subject headings
- Thyroid Cancer, Papillary
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 |
|---|---|---|
| Robotic thyroidectomy group | Robotic thyroidectomy group is the patient group who underwent robot-assisted endoscopic thyroid surgery using a gasless, trans-axillary approach. | |
| conventional open thyroidectomy group | Conventional open thyroidectomy group is th patient group who underwent thyroid surgery via neck incision. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid CarcinomaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 169 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
- NCT01311089
- Sponsor's protocol ID
- 1-2010-0055
- Status last verified
- Jan 2015
- First submitted
- 8 Mar 2011
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tan CT, Cheah WK, Delbridge L. "Scarless" (in the neck) endoscopic thyroidectomy (SET): an evidence-based review of published techniques. World J Surg. 2008 Jul;32(7):1349-57. doi: 10.1007/s00268-008-9555-3.
PubMed 18360737Kang SW, Lee SC, Lee SH, Lee KY, Jeong JJ, Lee YS, Nam KH, Chang HS, Chung WY, Park CS. Robotic thyroid surgery using a gasless, transaxillary approach and the da Vinci S system: the operative outcomes of 338 consecutive patients. Surgery. 2009 Dec;146(6):1048-55. doi: 10.1016/j.surg.2009.09.007. Epub 2009 Oct 30.
PubMed 19879615Jeong JJ, Kang SW, Yun JS, Sung TY, Lee SC, Lee YS, Nam KH, Chang HS, Chung WY, Park CS. Comparative study of endoscopic thyroidectomy versus conventional open thyroidectomy in papillary thyroid microcarcinoma (PTMC) patients. J Surg Oncol. 2009 Nov 1;100(6):477-80. doi: 10.1002/jso.21367.
PubMed 19653245Kang SW, Jeong JJ, Nam KH, Chang HS, Chung WY, Park CS. Robot-assisted endoscopic thyroidectomy for thyroid malignancies using a gasless transaxillary approach. J Am Coll Surg. 2009 Aug;209(2):e1-7. doi: 10.1016/j.jamcollsurg.2009.05.003. Epub 2009 Jun 12. No abstract available.
PubMed 19632588Chung YS, Choe JH, Kang KH, Kim SW, Chung KW, Park KS, Han W, Noh DY, Oh SK, Youn YK. Endoscopic thyroidectomy for thyroid malignancies: comparison with conventional open thyroidectomy. World J Surg. 2007 Dec;31(12):2302-6; discussion 2307-8. doi: 10.1007/s00268-007-9117-0.
PubMed 17566819Yoon JH, Park CH, Chung WY. Gasless endoscopic thyroidectomy via an axillary approach: experience of 30 cases. Surg Laparosc Endosc Percutan Tech. 2006 Aug;16(4):226-31. doi: 10.1097/00129689-200608000-00006.
PubMed 16921301Inukai M, Usui Y. Clinical evaluation of gasless endoscopic thyroid surgery. Surg Today. 2005;35(3):199-204. doi: 10.1007/s00595-004-2929-8.
PubMed 15772789Ohgami M, Ishii S, Arisawa Y, Ohmori T, Noga K, Furukawa T, Kitajima M. Scarless endoscopic thyroidectomy: breast approach for better cosmesis. Surg Laparosc Endosc Percutan Tech. 2000 Feb;10(1):1-4.
PubMed 10872517Ikeda Y, Takami H, Sasaki Y, Takayama J, Niimi M, Kan S. Comparative study of thyroidectomies. Endoscopic surgery versus conventional open surgery. Surg Endosc. 2002 Dec;16(12):1741-5. doi: 10.1007/s00464-002-8830-x. Epub 2002 Jul 29.
PubMed 12140635Lee J, Nah KY, Kim RM, Ahn YH, Soh EY, Chung WY. Differences in postoperative outcomes, function, and cosmesis: open versus robotic thyroidectomy. Surg Endosc. 2010 Dec;24(12):3186-94. doi: 10.1007/s00464-010-1113-z. Epub 2010 May 19.
PubMed 20490558
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy : Postoperative Body Image Change and Cosmetic Satisfaction
- ClinicalTrials.gov ID
- NCT01311089
- Acronym / sponsor ID
- 1-2010-0055
- Conditions
- Papillary Thyroid Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Mar 2011 (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.
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction.
Detailed description
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. In this study, we designed a prospective study comparing the cosmetic satisfaction and the postoperative body image change which associated with patient self-esteem between robotic thyroidectomy and conventional open thyroidectomy group.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic thyroidectomy group | – | –Robotic thyroidectomy group is the patient group who underwent robot-assisted endoscopic thyroid surgery using a gasless, trans-axillary approach. |
| conventional open thyroidectomy group | – | –Conventional open thyroidectomy group is th patient group who underwent thyroid surgery via neck incision. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 patients with papillary thyroid carcinoma who underwent thyroidectomy at Yonsei University Health System were enrolled. 60patients were conventional open thyroidectomy group and 60 patients were robotic thyroidectomy group. All of these patients was over 20 years old.
Key inclusion criteria (2 listed)
- Patients with papillary thyroid carcinoma who underwent thyroidectomy
- Age was over 20 years old
Key exclusion criteria (6 listed)
- Keloid
- Previous neck or anterior chest operation history
- The patients who underwent combined radical neck dissection
- The patient with postoperative wound problem
- The patient with underlying systemic disease which can make influences on the wound healing process
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Background: PubMed 18360737Tan CT, Cheah WK, Delbridge L. "Scarless" (in the neck) endoscopic thyroidectomy (SET): an evidence-based review of published techniques. World J Surg. 2008 Jul;32(7):1349-57. doi: 10.1007/s00268-008-9555-3.
- Background: PubMed 19879615Kang SW, Lee SC, Lee SH, Lee KY, Jeong JJ, Lee YS, Nam KH, Chang HS, Chung WY, Park CS. Robotic thyroid surgery using a gasless, transaxillary approach and the da Vinci S system: the operative outcomes of 338 consecutive patients. Surgery. 2009 Dec;146(6):1048-55. doi: 10.1016/j.surg.2009.09.007. Epub 2009 Oct 30.
- Background: PubMed 19653245Jeong JJ, Kang SW, Yun JS, Sung TY, Lee SC, Lee YS, Nam KH, Chang HS, Chung WY, Park CS. Comparative study of endoscopic thyroidectomy versus conventional open thyroidectomy in papillary thyroid microcarcinoma (PTMC) patients. J Surg Oncol. 2009 Nov 1;100(6):477-80. doi: 10.1002/jso.21367.
- Background: PubMed 19632588Kang SW, Jeong JJ, Nam KH, Chang HS, Chung WY, Park CS. Robot-assisted endoscopic thyroidectomy for thyroid malignancies using a gasless transaxillary approach. J Am Coll Surg. 2009 Aug;209(2):e1-7. doi: 10.1016/j.jamcollsurg.2009.05.003. Epub 2009 Jun 12. No abstract available.
- Background: PubMed 17566819Chung YS, Choe JH, Kang KH, Kim SW, Chung KW, Park KS, Han W, Noh DY, Oh SK, Youn YK. Endoscopic thyroidectomy for thyroid malignancies: comparison with conventional open thyroidectomy. World J Surg. 2007 Dec;31(12):2302-6; discussion 2307-8. doi: 10.1007/s00268-007-9117-0.
- Background: PubMed 16921301Yoon JH, Park CH, Chung WY. Gasless endoscopic thyroidectomy via an axillary approach: experience of 30 cases. Surg Laparosc Endosc Percutan Tech. 2006 Aug;16(4):226-31. doi: 10.1097/00129689-200608000-00006.
- Background: PubMed 15772789Inukai M, Usui Y. Clinical evaluation of gasless endoscopic thyroid surgery. Surg Today. 2005;35(3):199-204. doi: 10.1007/s00595-004-2929-8.
- Background: PubMed 10872517Ohgami M, Ishii S, Arisawa Y, Ohmori T, Noga K, Furukawa T, Kitajima M. Scarless endoscopic thyroidectomy: breast approach for better cosmesis. Surg Laparosc Endosc Percutan Tech. 2000 Feb;10(1):1-4.
- Background: PubMed 12140635Ikeda Y, Takami H, Sasaki Y, Takayama J, Niimi M, Kan S. Comparative study of thyroidectomies. Endoscopic surgery versus conventional open surgery. Surg Endosc. 2002 Dec;16(12):1741-5. doi: 10.1007/s00464-002-8830-x. Epub 2002 Jul 29.
- Background: PubMed 20490558Lee J, Nah KY, Kim RM, Ahn YH, Soh EY, Chung WY. Differences in postoperative outcomes, function, and cosmesis: open versus robotic thyroidectomy. Surg Endosc. 2010 Dec;24(12):3186-94. doi: 10.1007/s00464-010-1113-z. Epub 2010 May 19.
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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.
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?
An observational study of Papillary Thyroid Carcinoma, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jan 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311089, which also lists 10 linked publications.
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 27 Jan 2015.