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

Intraoperative Parathyroid Scores System Clinical Trial

— IPSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191344
• Other study ID #: IPSS
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2018
• Source: Fujian Medical University
• Contact: BO WANG, MS
• Phone: 13705947900
• Email: wangbo[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraoperative Parathyroid Scores System

Intervention

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

Locations

Country	Name	City	State
China	Wen-xin ZHAO	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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