Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy

NCT03411187 | Unknown

• 1 other identifier: exhaust
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic thyroidectomy developed rapidly in recent years, and the most popular surgical approach was endoscopic thyroidectomy by bilateral areola approach, but some operative steps was required optimization. One of the most annoying problem was the smog blurring endoscopic lens during surgery. The researcher summarized a set of convenient foot-control exhaust method and carried out this prospective study.

Conditions

Thyroid Cancer; Papillary Thyroid Carcinoma; Thyroidectomy; Endoscopy

Keywords

Endoscopy; Thyroidectomy; Thyroid Cancer

Outcome Measures

Primary Outcomes (3)

• Flap separation time

  Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.

  1 day after surgery

• Glandular excision time

  Glandular excision time was defined from incising cervical white line to removing Berry ligament.

  1 day after surgery

• Central lymph node dissection time

  Central lymph node dissection time: was from separating central lymph node to the specimen removed.

  1 day after surgery

Secondary Outcomes (6)

• Times of wiping lens

  1 day after surgery

• Volume of intraoperative blood loss

  1 day after surgery

• Volume of Postoperative drainage

  1 day，2 day，3 day after surgery

• The number of identifying parathyroid glands

  1 day after surgery

• Blood PTH level

  preoperative, first day after operation, one week after surgery, two months after surgery.

Study Arms (2)

foot-control exhaust group

ACTIVE COMPARATOR

The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust

Device: used of the Pressure adjustable foot-control method

direct exhaust group

PLACEBO COMPARATOR

direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method

Device: direct exhaust

Interventions

used of the Pressure adjustable foot-control method DEVICE

Whether The Pressure adjustable foot-control method is used.

foot-control exhaust group

direct exhaust DEVICE

direct exhaust through the trocar.

direct exhaust group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with maximum tumor diameter ≤1 cm;
• patients without lateral neck lymph node metastases;
• patients without distant metastases;
• patients who only needed unilateral surgery following the guidelines;
• patients with strong cosmetic requirement.

You may not qualify if:

• Patients with maximum tumor diameter \>1 cm;
• patients who needed complement total thyroidectomy according to the guidelines, including tumor extrathyroidal extension as well as large amount of neck lymph node metastases and distant metastases;
• patients without cosmetic requirements.

Sponsors & Collaborators

• Bo Wang,MD: lead

Study Sites (1)

Wen-xin ZHAO

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Wen-xin ZHAO, MD

CONTACT

8613365910359; zhaowx@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This study is a prospective randomized controlled study to select a continuous case of thyroid surgery in the fujian medical university union hospital from January 2017 to June 2017.

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 26, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: December 30, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)