CClinicalTrials.gg
Status unknownNCT03411187Updated Sep 18, 2018

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

An interventional study of used of the Pressure adjustable foot-control method and direct exhaust in Thyroid Cancer, Papillary Thyroid Carcinoma and Thyroidectomy, sponsored by Bo Wang,MD. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by Bo Wang,MD · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

The patients with papillary thyroid microcarcinoma were included according to the inclusive criteria and randomly divided them into two groups (foot-control exhaust group and direct exhaust group). The foot-control exhaust group used the foot-control exhaust method by the way of adjustable Pressure to intermittent exhaust, while direct exhaust group exhaust through the Trocar hole. Comparison of operation time, times of wiping the endoscopic lens, volume of postoperative drainage, and number of identified parathyroid gland between two groups.

02

Conditions studied

  • Thyroid Cancer
  • Papillary Thyroid Carcinoma
  • Thyroidectomy
  • Endoscopy

Keywords

  • Endoscopy
  • Thyroidectomy
  • Thyroid Cancer
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  1. Patients with maximum tumor diameter >1 cm;
  2. 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;
  3. patients without cosmetic requirements.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    foot-control exhaust group

    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

  • Placebo comparator
    direct exhaust group

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

    Device: direct exhaust

Interventions

  • Deviceused of the Pressure adjustable foot-control method

    Whether The Pressure adjustable foot-control method is used.

  • Devicedirect exhaust

    direct exhaust through the trocar.

05

What researchers measure

Primary outcomes

  1. Flap separation time

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

    Time frame: 1 day after surgery

  2. Glandular excision time

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

    Time frame: 1 day after surgery

  3. Central lymph node dissection time

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

    Time frame: 1 day after surgery

Secondary outcomes

  1. Times of wiping lens

    Times of wiping lens calculated from endoscopic video after operation was defined the times of wiping lens from endoscopy into the body to central lymph node removed.

    Time frame: 1 day after surgery

  2. Volume of intraoperative blood loss

    Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.

    Time frame: 1 day after surgery

  3. Volume of Postoperative drainage

    Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.

    Time frame: 1 day,2 day,3 day after surgery

  4. The number of identifying parathyroid glands

    The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.

    Time frame: 1 day after surgery

  5. Blood PTH level

    measurement of PTH level in blood

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

  6. Blood calcium level

    to measure the blood calcium level in the blood

    Time frame: before surgery, the first day after surgery, one week after surgery, two months after surgery.

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03411187
Lead sponsor
Bo Wang,MD
Responsible party
Bo Wang,MD (Clinical Professor, Fujian Medical University) — Sponsor-investigator
First posted
Jan 26, 2018
Start date
Jan 1, 2018
Primary completion
Jun 30, 2018
Completion
Dec 30, 2018 (estimated)
Last update
Sep 18, 2018

Study contacts

Wen-xin ZHAO, MD
Contact
zhaowx@fjmu.edu.cn
8613365910359

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion