No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-10-01

Brief Summary

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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.

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Detailed Description

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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

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Drainage Thyroid Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Routine application of drainage tube

After TOETVA, patients will receive one drainage tube through anterior cervical area.

Group Type NO_INTERVENTION

No interventions assigned to this group

Omission of drainage tube

After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.

Group Type EXPERIMENTAL

no drainage tube applied

Intervention Type PROCEDURE

No drainage tube implacement after TOETVA

Interventions

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no drainage tube applied

No drainage tube implacement after TOETVA

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No