Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)
Primary Purpose
Goiter
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Total Thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Goiter focused on measuring Goiter [C19.874.283], Thyroid Neoplasms [C19.874.788]
Eligibility Criteria
Inclusion Criteria:
- Patient is over 18 years old
- Patient scheduled for a non-emergency operation
- Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
Exclusion Criteria:
- Patient had a previous operation at the thyroid
- Patient is participating in another clinical trial which may affect this study's outcomes
- Patient in toxic condition (non euthyroid or hypothyroid )
- Patient receiving anticoagulation treatment for other medical condition
- Echographic evidence that the size at least one nodule is more than 4cm
Sites / Locations
- 3rd Department of Surgery, AHEPA University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
mini Video Assisted Thyroidectomy (miVAT)
Classic Total Thyroidectomy
Outcomes
Primary Outcome Measures
Comparison of the late postoperative course and complications of the patients using the two techniques
Secondary Outcome Measures
Full Information
NCT ID
NCT00693147
First Posted
June 5, 2008
Last Updated
September 29, 2012
Sponsor
Aristotle University Of Thessaloniki
Collaborators
AHEPA University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00693147
Brief Title
Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)
Official Title
Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
AHEPA University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Protocol Synopsis
Protocol title: Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)
Purpose: Comparison of the late postoperative course and complications of the patients using the two techniques
Design: Prospective, single-center randomized study
Patient Population: Male or female subjects 18 years of age or older with nodular goiter who are scheduled for total thyroidectomy (miVAT or T)
No. of Subjects: 100 patients divided into two groups, estimated up to 1 year to enroll
Duration of Treatment: During the operation
Duration of Follow-up: Follow-up will be performed by evaluation at the 3rd and 6th postoperative month ±5 days
Endpoints: To evaluate the long term safety of each technique
Detailed Description
1.0 INTRODUCTION
Classic articles by Kocher, Halsted, Lahey, Crile and Riddell have provided surgeons with principles that have significantly reduced operative morbidity and mortality from thyroidectomy. Nowadays, surgery of the thyroid gland is considered safe with practically null mortality. Morbidity, although infrequent, is still a reason for concern. The complications directly attributed to total thyroidectomy are hypoparathyroidism, recurrent laryngeal nerve injury, hemorrhage, oesophageal perforation and trachea instability and perforation. Furthermore, other complications, related to the surgical technique, such as seroma or wound infection, may also occur.
Several techniques are employed in order to resect the suffering thyroid gland. Classic thyroidectomy (T) is considered today, the golden standard of total thyroid resection for nodular goiter. One the other hand, new technologies and great experience of several surgeons gave recently birth to a new technique named mini Video Assisted Thyroidectomy (miVAT).
This protocol is designed to compare data in regards to T versus miVAT in the late postoperative period.
2.0 OBJECTIVES
To compare the late postoperative course and complications of the patients using the two techniques (T and miVAT).
3.0 DESIGN AND STUDY POPULATION
The study is designed as a prospective randomized single center study. Any patient that is scheduled for a total thyroidectomy for nodular goiter with nodules less that 4cm will be offered participation in this study.
4.0 STUDY PROCEDURE
4.1 Pre-Surgery
Procedures preformed such as routine hospital examinations, antibiotic prophylactic treatment, anticoagulant treatment and diet will be according to the standard management protocol and will be recorded for the study. The following pre-surgery information will be recorded:
Demographic information including: Date of birth (age), gender, ethnicity
Height, weight and ASA status
Behavioral history (Smoking, alcohol or drug use)
Preoperative labs (WBC, Ht, Hgb, SGOT, SGPT, LDH, Glc, Ure, Cre, K+, Na+, Ca2+,Mg2+, TP, ALB, fT3, fT4, TSH, PTH, PT, aPTT, INR)
Diagnosis including clinical observations and previous imaging results
FNA results (if any)
Medications
Current and past history of surgical and medical comorbidities
Vocal cord assessment by indirect laryngoscopy
4.2 Intra-operative
The surgeon will perform the preplanned operation. Each recurrent laryngeal nerve has to be identified and its activity has to be recorded. The following intraoperative variables will be recorded for all patients:
Surgery date
Left laryngeal nerve activity
Right laryngeal activity
Method of devascularization of right lobe
Method of devascularization of left lobe
Technical complications
Estimated blood loss
Duration of surgery
Difficulty of the operation (1=very difficult to 5=very easy)
Operation performed
Procedure related comments
Usage of drains (number and type)
Usage of haemostatic material
Length of the incision
4.3 Pathology data form
The following pathology data will be recorded for all patients:
Post-operative diagnosis including pathology report
Weight of the gland
Dimensions of the gland
4.4 Postoperative follow-up
Follow-up evaluation will be performed on the 3rd and 6th month. The following information will be recorded:
Wound infection
Average Pain score for patient resting and moving/day
Postoperative labs (WBC, Ht, Hgb, SGOT, SGPT, LDH, Glc, Ure, Cre, K+, Na+, Ca2+,Mg2+, TP, ALB, fT3, fT4, TSH, PTH, PT, aPTT, INR)
Sign of hypoparathyroidism (Chvostek and Trousseau)
Vocal alterations by patient (voice completely altered=10 to voice not altered=1)
Vocal cord assessment by indirect laryngoscopy
Comments
5.0 COMPLICATIONS AND ADVERSE EVENTS
The investigator is required to notify the coordinator of any serious adverse events. The coordinator is also required to notify the Ethics Committee according to local regulations and requirements.
Serious Adverse Events include:
Death regardless of cause
Any-life-threatening event
Any hospitalization or prolongation of existing hospitalization
Any event that results in persistent or significant disability or incapacity to the patient.
6.0 STATISTICAL ANALYSIS
The objective of this study is to compare the T with the miVAT techniques concerning the immediate postoperative course of the patients in relation to complications during and post procedure.
Statistical analysis included description of these intraoperative and postoperative outcomes, and indication of patient characteristics associated with these outcomes.
In order to efficiently compare the two techniques random allocation of the patients within two groups (Group A=T and Group B=miVAT) was employed. All patient with even number were included in group A, while all patients with odd number were included in group B.
Since the study does not have pre-specified hypotheses all statistical analyses are exploratory and interpretation of results should be within this context.
7.0 DATA MONITORING PLAN
The coordinator will monitor all data accrual. Furthermore, the coordinator will review the progress of the clinical trial including safety data and ensure as possible that it is conducted, recorded and reported in accordance with the protocol, good clinical practice and the applicable regulatory requirements.
8.0 DATA CONFIDENTIALITY
Each patient ill be identified by his/her initials and a unique patient identification number. Source data will be stored with source documents. Only personnel responsible for collecting data and transcribing it into the case report forms will have access to the data. Records will remain on site in secure areas.
10.0 ETHICS
Prior to study institution review board (IRB) approval should be obtained. Any changes in the study protocol, informed consent forms, or investigator must be re-approved by the IRB. All patients enrolled in the study will provide their consent prior to entering the study. An informed consent form shall be signed and dated by the patient. The investigator will retain the forms as part of the study records.
This study will be executed in accordance with the Declaration of Helsinki, in agreement with the guidelines for conducting a clinical investigation in accordance with the principles of ICH GCP outlined in the E6 document. By signing the present protocol, participants in the study commit themselves to carry it out in accordance with local legal requirements.
11.0 INFORMED CONSENT
All eligible patients should have the capacity to provide an informed consent. The above described inclusion and exclusion criteria were designed to ensure the entry of the appropriate population of patients to this study and will be approved by the local IRB. Screening for these criteria will be conducted by the coordinator.
Eligible patients will be educated about the research proposal by a study investigator. To determine whether the patient has understood the issues, he/she will be asked to describe what the research entails and whether they have any questions. All questions will be addressed prior to enrollment. The patient can refuse participation in the study at any time.
A written informed consent form will be generated. For each patient, a case report form (CRF) will be completed, providing general medical information and history.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Goiter
Keywords
Goiter [C19.874.283], Thyroid Neoplasms [C19.874.788]
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
mini Video Assisted Thyroidectomy (miVAT)
Arm Title
B
Arm Type
Active Comparator
Arm Description
Classic Total Thyroidectomy
Intervention Type
Procedure
Intervention Name(s)
Total Thyroidectomy
Intervention Description
Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)
Primary Outcome Measure Information:
Title
Comparison of the late postoperative course and complications of the patients using the two techniques
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is over 18 years old
Patient scheduled for a non-emergency operation
Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
Exclusion Criteria:
Patient had a previous operation at the thyroid
Patient is participating in another clinical trial which may affect this study's outcomes
Patient in toxic condition (non euthyroid or hypothyroid )
Patient receiving anticoagulation treatment for other medical condition
Echographic evidence that the size at least one nodule is more than 4cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spiros Papavramidis, Prof
Organizational Affiliation
Director of the 3rd department of surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kostantinos Sapalidis
Organizational Affiliation
Surgeon
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Theodossis S Papavramidis
Organizational Affiliation
Trainee in Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikolaos Michalopoulos
Organizational Affiliation
Trainee in Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgios Gkoutzamanis
Organizational Affiliation
Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
3rd Department of Surgery, AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
55236
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)
We'll reach out to this number within 24 hrs