HemorrhageNCT00506103
The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study
An observational study of Hemorrhage and Hypocalcemia, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemorrhage, Hypocalcemia, Vocal Cord Palsy
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2006to Jun 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with total thyroidectomy plus central neck dissection
- if primary tumor size was more than 1 cm in papillary thyroid cancer
- there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively
- patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer
Who cannot join
- patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis
- patients had clinical or laboratory indicators of coagulation disorders
- patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve
- patients with massive extracapsular extension to the surrounding soft tissues.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
Bucheon-si
About this study
To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation.
- Conditions
- Hemorrhage, Hypocalcemia, Vocal Cord Palsy
- Keywords
- Thyroidectomy, Central neck dissection, Harmonic scalpel, Perioperative complications
- Medical subject headings
- Hemorrhage, Hypocalcemia, Vocal Cord Paralysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startOct 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yoon Woo Koh, MD, Principal investigator, Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506103
- Sponsor's protocol ID
- SCHHN
- Status last verified
- Jul 2007
- First submitted
- 21 Jul 2007
- Last updated
- 26 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cordon C, Fajardo R, Ramirez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery. 2005 Mar;137(3):337-41. doi: 10.1016/j.surg.2004.09.011.
PubMed 15746789
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00506103
- Acronym / sponsor ID
- SCHHN
- Conditions
- Hemorrhage, Hypocalcemia, Vocal Cord Palsy
- Keywords
- Thyroidectomy, Central neck dissection, Harmonic scalpel, Perioperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Jul 2007 (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.
To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients with total thyroidectomy plus central neck dissection
- if primary tumor size was more than 1 cm in papillary thyroid cancer
- there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively
- patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer
Key exclusion criteria (4 listed)
- patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis
- patients had clinical or laboratory indicators of coagulation disorders
- patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve
- patients with massive extracapsular extension to the surrounding soft tissues.
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 26 Jul 2007.
- Background: PubMed 15746789Cordon C, Fajardo R, Ramirez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery. 2005 Mar;137(3):337-41. doi: 10.1016/j.surg.2004.09.011.
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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.
Yoon Woo Koh, MD principal investigator
Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
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 Hemorrhage and Hypocalcemia, run by Soonchunhyang University Hospital 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 4 inclusion and 4 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 26 Jul 2007. 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 NCT00506103, which also lists 1 linked publication.
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 26 Jul 2007.