Clinical trial · Interventional
No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)
The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma
NCT04931576CI-TRIAL-00059267unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drainage | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no drainage tube applied | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Routine application of drainage tube
- description
- After TOETVA, patients will receive one drainage tube through anterior cervical area.
- type
- EXPERIMENTAL
- label
- Omission of drainage tube
- description
- After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.
- interventionNames
- Procedure: no drainage tube applied
Primary outcomes (3)
- measure
- The incidence rate of hemorrhage on week 1 after surgery
- timeFrame
- 1 week
- description
- To evaluate the incidence rate of postoperative hemorrhage (hemorrhage of surgical sites which requires reoperation)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing thyroid surgery for the first time 2. The surgical method is TOETVA 3. There is no lateral cervical lymph node metastasis assessed before surgery 4. Fine-needle aspiration revealed palpilary thyroid carcinoma 5. It meets the surgical indications and has no obvious surgical contraindications Exclusion Criteria: 1. previous history of thyroid surgery; 2. conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillary approach; 3. patients undergoing cervical lateral lymph node dissection; 4. past or current history of hyperthyroidism; 5. history of combined hypertension, diabetes, coagulation dysfunction, or other important organ dysfunction diseases.
References
Publications (3)
- BACKGROUNDSchietroma 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. PMID 28715809
- BACKGROUNDSoh 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. PMID 33022081
- BACKGROUNDFernandez 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. PMID 31951503