DrainageNCT04931576
No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)
A study testing no drainage tube applied in people with Drainage and Thyroid Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study evaluates the viability and safety of no drainage tube placement during transoral endoscopic thyroidectomy vestibular approach in treatment of patients with papillary thyroid carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Drainage, Thyroid Cancer
- What is being tested?
- no drainage tube applied
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Oct 2023
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing thyroid surgery for the first time
- The surgical method is TOETVA
- There is no lateral cervical lymph node metastasis assessed before surgery
- Fine-needle aspiration revealed palpilary thyroid carcinoma
- It meets the surgical indications and has no obvious surgical contraindications
Who cannot join
- previous history of thyroid surgery;
- conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillary approach;
- patients undergoing cervical lateral lymph node dissection;
- past or current history of hyperthyroidism;
- history of combined hypertension, diabetes, coagulation dysfunction, or other important organ dysfunction diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang
Zhiyu Li, zrlizy@zju.edu.cn
About this study
Official title: The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma
This study evaluates the viability and safety of no drainage tube placement during transoral endoscopic thyroidectomy vestibular approach in treatment of patients with papillary thyroid carcinoma.
Read the detailed description
Transoral endoscopic thyroidectomy vestibular approach (TOETVA) is widely used due to its excellent cosmetic effect without scars on the body surface. In prevention of postoperative hemorrhage, a postoperative drainage tube is routinely placed in the surgical area. However, current opinion suggest that under the circumstance of strict and effective intraoperative hemostasis, routine application of drainage tube is unnecessary in conventional open thyroidectomy(COT). The research about drainage placement decision during endoscopic thyroidectomy is scarce currently. This study evaluates the viability and safety of no drainage tube placement during TOETVA on papillary thyroid carcinoma.
Patients allocated to the intervention group will implace no drainage tube during TOETVA and those allocated in control group will implace one drainage tube routinely.
The incidence of postoperative complications will be evaluated. The time of postoperative hospital-stay and operation time will be evaluated as well. At the same time, blood test results like WBC and CRP will be evaluated 1 day after surgery.
- Conditions
- Drainage, Thyroid Cancer
- Being tested
- no drainage tube applied
- Keywords
- Drainage, TOETVA, Palpilary Thyroid Carcinoma, complications
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no drainage tube appliedProcedure or surgery
No drainage tube implacement after TOETVA
| Study group | Role | What they receive |
|---|---|---|
| Routine application of drainage tube | No intervention | After TOETVA, patients will receive one drainage tube through anterior cervical area. |
| Omission of drainage tube | Experimental | After TOETVA, patients will receive complete omission of drianage tube and directly close the incision. Receives: Procedure: no drainage tube applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of hemorrhage on week 1 after surgery
To evaluate the incidence rate of postoperative hemorrhage (hemorrhage of surgical sites which requires reoperation)
Measured: 1 week
The incidence rate of infections on week 2 after surgery
To evaluate the incidence rate of infections of surgical sites
Measured: 2 week
The incidence rate of postoperative hematoma or seroma on week 2 after surgery
To evaluate the incidence rate of postoperative hematoma or seroma
Measured: 2 week
Secondary outcomes (5)
Pain score on day 1 after surgery
To evaluate the pain score via numerical rating scale on day 1 after surgery. An 11-point numeric scale (NRS 11) with 0 representing no pain and 10 representing worst pain imaginable.
Measured: 1 day
Body temperature on day 1 after surgery
To evaluate the body temperature on day 1 after surgery.
Measured: 1 day
WBC on day 1 after surgery
To evaluate the white blood count on day 1 after surgery.
Measured: 1 day
CRP on day 1 after surgery
To evaluate the C-reaction protein on day 1 after surgery.
Measured: 1 week
Length of post-operative hospital stay
To evaluate the length of post-operative hospital stay.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DrainageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931576
- Sponsor's protocol ID
- 2021-0316
- Status last verified
- May 2022
- First submitted
- 14 Jun 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schietroma M, Pessia B, Bianchi Z, De Vita F, Carlei F, Guadagni S, Amicucci G, Clementi M. Thyroid Surgery: To Drain or Not to Drain, That Is the Problem - A Randomized Clinical Trial. ORL J Otorhinolaryngol Relat Spec. 2017;79(4):202-211. doi: 10.1159/000464137. Epub 2017 Jul 15.
PubMed 28715809Soh TCF, Ong QJ, Yip HM. Complications of Neck Drains in Thyroidectomies: A Systematic Review and Meta-Analysis. Laryngoscope. 2021 Mar;131(3):690-700. doi: 10.1002/lary.29077. Epub 2020 Oct 6.
PubMed 33022081Fernandez Ranvier G, Meknat A, Guevara DE, Llorente PM, Vidal Fortuny J, Sneider M, Chen YH, Inabnet W 3rd. International Multi-institutional Experience with the Transoral Endoscopic Thyroidectomy Vestibular Approach. J Laparoendosc Adv Surg Tech A. 2020 Mar;30(3):278-283. doi: 10.1089/lap.2019.0645. Epub 2020 Jan 17.
PubMed 31951503
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT04931576
- Acronym / sponsor ID
- 2021-0316
- Conditions
- Drainage, Thyroid Cancer
- Keywords
- Drainage, TOETVA, Palpilary Thyroid Carcinoma, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- 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.
This study evaluates the viability and safety of no drainage tube placement during transoral endoscopic thyroidectomy vestibular approach in treatment of patients with papillary thyroid carcinoma.
Detailed description
Transoral endoscopic thyroidectomy vestibular approach (TOETVA) is widely used due to its excellent cosmetic effect without scars on the body surface. In prevention of postoperative hemorrhage, a postoperative drainage tube is routinely placed in the surgical area. However, current opinion suggest that under the circumstance of strict and effective intraoperative hemostasis, routine application of drainage tube is unnecessary in conventional open thyroidectomy(COT). The research about drainage placement decision during endoscopic thyroidectomy is scarce currently. This study evaluates the viability and safety of no drainage tube placement during TOETVA on papillary thyroid carcinoma.
Patients allocated to the intervention group will implace no drainage tube during TOETVA and those allocated in control group will implace one drainage tube routinely.
The incidence of postoperative complications will be evaluated. The time of postoperative hospital-stay and operation time will be evaluated as well. At the same time, blood test results like WBC and CRP will be evaluated 1 day after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine application of drainage tube | No intervention | –After TOETVA, patients will receive one drainage tube through anterior cervical area. |
| Omission of drainage tube | Experimental | Procedure: no drainage tube appliedAfter TOETVA, patients will receive complete omission of drianage tube and directly close the incision. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients undergoing thyroid surgery for the first time
- The surgical method is TOETVA
- There is no lateral cervical lymph node metastasis assessed before surgery
- Fine-needle aspiration revealed palpilary thyroid carcinoma
- It meets the surgical indications and has no obvious surgical contraindications
Key exclusion criteria (5 listed)
- previous history of thyroid surgery;
- conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillary approach;
- patients undergoing cervical lateral lymph node dissection;
- past or current history of hyperthyroidism;
- history of combined hypertension, diabetes, coagulation dysfunction, or other important organ dysfunction diseases.
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 |
|---|---|---|
| no drainage tube appliedNo drainage tube implacement after TOETVA | Procedure or surgery | Omission of drainage tube |
Primary outcome
The incidence rate of hemorrhage on week 1 after surgery
Time frame: 1 week
To evaluate the incidence rate of postoperative hemorrhage (hemorrhage of surgical sites which requires reoperation)
The incidence rate of infections on week 2 after surgery
Time frame: 2 week
To evaluate the incidence rate of infections of surgical sites
The incidence rate of postoperative hematoma or seroma on week 2 after surgery
Time frame: 2 week
To evaluate the incidence rate of postoperative hematoma or seroma
5 secondary outcomes
Pain score on day 1 after surgery
Time frame: 1 day
Body temperature on day 1 after surgery
Time frame: 1 day
WBC on day 1 after surgery
Time frame: 1 day
CRP on day 1 after surgery
Time frame: 1 week
Length of post-operative hospital stay
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Background: PubMed 28715809Schietroma M, Pessia B, Bianchi Z, De Vita F, Carlei F, Guadagni S, Amicucci G, Clementi M. Thyroid Surgery: To Drain or Not to Drain, That Is the Problem - A Randomized Clinical Trial. ORL J Otorhinolaryngol Relat Spec. 2017;79(4):202-211. doi: 10.1159/000464137. Epub 2017 Jul 15.
- Background: PubMed 33022081Soh TCF, Ong QJ, Yip HM. Complications of Neck Drains in Thyroidectomies: A Systematic Review and Meta-Analysis. Laryngoscope. 2021 Mar;131(3):690-700. doi: 10.1002/lary.29077. Epub 2020 Oct 6.
- Background: PubMed 31951503Fernandez Ranvier G, Meknat A, Guevara DE, Llorente PM, Vidal Fortuny J, Sneider M, Chen YH, Inabnet W 3rd. International Multi-institutional Experience with the Transoral Endoscopic Thyroidectomy Vestibular Approach. J Laparoendosc Adv Surg Tech A. 2020 Mar;30(3):278-283. doi: 10.1089/lap.2019.0645. Epub 2020 Jan 17.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no drainage tube applied in people with Drainage and Thyroid Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 5 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 23 Jun 2022. 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 China. 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?
Contact Li Zhiyu, Ph.D (+86-13858169479, drlizy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of hemorrhage on week 1 after surgery (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04931576, which also lists 3 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 23 Jun 2022.