Extended Application of Intraoperative Parathyroid Scores System(IPSS) in Thyroidectomy


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Verified June 2017 by wangbo, Fujian Medical University

Sponsor:

Information provided by (Responsible Party):

wangbo, Fujian Medical University

ClinicalTrials.gov Identifier:

NCT03191344

First received: June 15, 2017

Last updated: June 15, 2017

Last verified: June 2017

after established the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy we further extented the clinical value of Intraoperative Parathyroid Scores System in Treatment decisions of calcium treatment time and improve recognition skills of parathyroid in Clinicians

Intraoperative Parathyroid Scores System Behavioral: with IPSS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extended Application of Intraoperative Parathyroid Scores System(IPSS) in Thyroidectomy

Primary Outcome Measures:

Secondary Outcome Measures:

Other Outcome Measures:

Estimated Enrollment: 300
Anticipated Study Start Date: July 1, 2017
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)
with IPSS

one group for the surgoen use the IPSS

Behavioral: with IPSS

all patient in one group use IPSS to record the parathyroid status. the other group operation as ordinary. record the parathyroid status in verbal description

without IPSS

one group for the surgoen without the IPSS

IPSS includes transplantation Parathyroid Scores and in situ Parathyroid Scores, the investigators will establish the Intraoperative Parathyroid Scores System by parathyroid size and Blood supply, and recording IPSS, according to certain rules. We expand IPSS, including the description of the location of parathyroid after postoperative.Parathyroid hormone and calcium were test in d0, d1, d14, d60 post operation. The correlation between Intraoperative Parathyroid Scores and PTH calcium were calculated, and ROC curve and logistic regression were tested for the prediction value.and after that we further evaluate the relationship Between IPSS and calcium supplement time.and Whether IPSS enhance ability of parathyroid recognition for clinical doctors.

Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

the patients with thyroid tumors and require surgery In accordance with the guidelines.

Inclusion Criteria:

  1. postoperative pathology confirmed as thyroid papillary carcinoma;
  2. for the first time to undergo thyroid surgery, no history of neck surgery and external radiotherapy;
  3. preoperative serum calcium, parathyroid hormone levels were normal;
  4. intraoperative and postoperative clinical data integrity, standardized follow-up patients;
  5. parathyroid is a tumor violation.

Exclusion Criteria:

  1. serious underlying disease;
  2. age greater than 60 years of age or combined with arteriosclerotic disease;
  3. patients with postoperative loss;
  4. patients with parathyroid disease.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT03191344

Wen-xin ZHAO
Fuzhou, Fujian, China, 350001

Fujian Medical University

Responsible Party: wangbo, MS, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03191344     History of Changes
Other Study ID Numbers: IPSS
Study First Received: June 15, 2017
Last Updated: June 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by wangbo, Fujian Medical University:

Intraoperative Parathyroid Scores System
total thyroidectomy
thyroid cancer
hypoparathyroidism
prediction

ClinicalTrials.gov processed this record on June 19, 2017