Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111616347833 Date of Approval: 29/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Predictors for post thyroidectomy hypocalcemia
Official scientific title Indocyanine Green Angiography of Parathyroid Glands Versus Intraoperative Parathyroid Hormone Assay as a Reliable Predictor for Post Thyroidectomy Transient Hypocalcemia
Brief summary describing the background and objectives of the trial Indocyanine Green (ICG) angiography of parathyroid glands is a feasible method to detect the perfusion of parathyroid glands and so predicting the postoperative hypocalcemia. Our aim was to compare between the ICG angiography score and intraoperative intact parathyroid hormone (PTH) level assay in prediction of postoperative transient hypocalcemia.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/04/2018
Actual trial start date 07/04/2018
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date 17/03/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ICG angiography All cases underwent ICG angiography which was detected by endoscope within minutes Intraoperative IV injection of ICG to score the viability of each parathyroid gland in thyroidectomy 90
Control Group Intraoperative parathyroid hormone assay All cases underwent intraoperative parathyroid hormone assay 10 minutes after thyroidectomy and needs at least 20 minutes to be obtained Peripheral vein sample was taken 10 minutes after thyroidectomy to measure the intraoperative parathyroid hormone assay 90 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients candidate for total thyroidectomy were included in the study All 4 PTGs were identified intraoperatively. The range of age of included cases was from 18 to 65 years old The patients accepted to share in the study. The patients comleted the follow up duration Cases of hemi thyroidectomy Completion thyroidectomy Recurrent thyroidectomy Cervical lymph node dissection . Preoperative hypocalcemia or hypoparathyroidism Previous parathyroid surgery or parathyroid pathology Cases with less than 4 PTGs identified intraoperatively were excluded. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/04/2018 General surgery department ethical committe
Ethics Committee Address
Street address City Postal code Country
Ramsis street cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The diagnostic accuracy between ICG angiography and intraoperative parathyroid hormone level to predict postoperative hypocalcemia Postoperatively we correlate between the presence of postoperative hypocalcemia ,clinical and day 1 serum calcium, and the results of ICG score and intraoperative parathyroid hormone level
Secondary Outcome Duration of procedure, the complication of procedure Intraoperative detection of duration of ICG angiography and intraoperative parathyroid hormone assay and the complication of ICG
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Endocrine surgery unite at Ain shams university hospials 318 Ramsis St., Abbasia, Cairo, Egypt. Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hossam Sobhy Abdelrahim Ramses street Cairo 002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The authors of the study were the only sponsors with no external sponsoring Ramsis street Cairo 002 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam Sobhy Abdelrahim Hosam_l_n@yahoo.com 00201110540267 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Ahmed Fouad Amer dr.ahmedfouad@med.asu.edu.eg 00201006208888 Ramsis street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of general surgery faculty of medicine Ain Shams University Hospitals
Role Name Email Phone Street address
Scientific Enquiries Ramy Mikhael Ramy_mikha@med.asu.edu.eg 00201227923350 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Assistant professor of general surgery faculty of medicine Ain Shams University Hospitals.
Role Name Email Phone Street address
Public Enquiries Mohammed Hisham Goda drmohamedhisham@yahoo.com 00201116729398 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery faculty of medicine Ain Shams University Hospitals.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Hosam_l_n@yahoo.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information