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

• Conditions: Intraoperative Parathyroid Scores System
• Interventions: Behavioral: with IPSS

• Registration Number: NCT03191344
• Lead Sponsor: Fujian Medical University

Brief 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

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 Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Study Start: 2017-07-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with IPSS record/IPSS	with IPSS	the surgoen use the IPSS in all thyroidectomy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wen-xin ZHAO; 🇨🇳 Fuzhou, Fujian, China