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

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

Study Overview

• Status: Unknown
• Conditions: Intraoperative Parathyroid Scores System
• Intervention / Treatment: Behavioral: with IPSS

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: BO WANG, MS; Phone Number: 13705947900; Email: wangbo@fjmu.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Wen-xin ZHAO
      • Contact: Bo WANG, MS; Phone Number: 8613705947900; Email: wangbo@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
with IPSS record/IPSS; the surgoen use the IPSS in all thyroidectomy	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
Traditionaldescription Group/TD; the surgoen without the IPSS，use Traditional description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences of parathyroid records between IPSS and TD	The percentage of recorded integrity of the parathyroid gland and the number of recognizable parathyroids were compared between the two groups.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of IPSS on the level of parathyroid recognition of surgeons	Comparison of the number of parathyroid gland found in the pathology and the number of postoperative hypoparathyroidism between the two groups	1 year
differences of the number of parathyroid glands found in the pathology betwen IPSS and TD	differences of the number of parathyroid glands found in the pathology betwen IPSS and TD	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Predictive Value of IPSS for Intravenous and Oral Calcium duration	Comparison of the correlation between IPSS values and intravenous calcium supplementation and oral calcium supplementation time.	1 year

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (ACTUAL): June 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: thyroid cancer; prediction; hypoparathyroidism; total thyroidectomy; Intraoperative Parathyroid Scores System
• Other Study ID Numbers: IPSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No