Oxidized Cellulose Hemostatic Agent in Thyroid Surgery: a Prospective

Status Active, not recruiting

Clinical Trial Summary

This single-blind prospective randomized study was designed to assess the efficacy and safety of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery

Clinical Trial Description

patients who require a thyroidectomy will be enrolled after informed consent will begiven. Prior to thyroidectomy, patients will be randomized to two groups: 1) use of conventional surgical procedures to achieve hemostasis,i.e., ligatures and bipolar electrocauterization alone, and 2) use of oxidized cellulose patch (Surgicel©) in addition to classical methods (ligature; bipolar electrocautery). All anticoagulants will be discontinued 10 days prior to the operation, if this will not be possible the patient will be excluded. The investigators will perform the specified procedure in accordance with accepted clinical practice standards. At the end of the thyroidectomy, a meticulous hemostasis will be achieved. Before wound closure, the sealed affiliation envelopes will be opened and 1-2×2 cm oxidized cellulose patch will be placed over the thyroid bed depending on patient randomization. Next, a suction drain will be placed. The drains will be removed when the secretion volume/day will be less than 20 cc.

All operations will be performed under general anesthesia by three head and neck surgeons who had experience in thyroid surgery. Outcome measures will include duration of operation, hemodynamic variables on emergence (blood pressure and heart rate), volume of secretion in the drain, time to removal of wound drain, length of postoperative hospital stay, and incidence of postoperative complications, i.e. hemorrhage, transient hypoparathyroidism, wound infection, seroma, and recurrent laryngeal nerve palsy. Evaluation of the postoperative course and recording of data will be done by one surgeons blinded to the intervention (MA). Follow-up for this study will be ended one month after the surgery. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01756534
Study type	Interventional
Source	Tel-Aviv Sourasky Medical Center
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 2011
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04614389` - Utility of Contrast-Enhanced Sonography and Shear Wave Elastography	N/A
Recruiting	`NCT03295955` - Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy	N/A
Completed	`NCT04647006` - Comparison of TOETVA and Conventional Thyroidectomy	N/A
Not yet recruiting	`NCT06029946` - B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules
Recruiting	`NCT05025046` - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Terminated	`NCT01320813` - Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy	N/A
Completed	`NCT00877630` - Minimal Invasiveness of Endoscopic Thyroidectomy	N/A
Completed	`NCT01964508` - microRNA in Thyroid Cancer
Completed	`NCT06306599` - Ultrasound Operator Influence on Diagnostics With AI for Thyroid Nodules - Clinial Trial	N/A
Recruiting	`NCT04730726` - In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules	N/A
Not yet recruiting	`NCT03884140` - Clinical Diagnostic Approach for Cases of Thyroid Nodules
Completed	`NCT04277455` - Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules	N/A
Recruiting	`NCT02225509` - Clinical Validation of a Molecular Signature to Detect Cancer in Thyroid Nodules With Indeterminate Cytology	N/A
Completed	`NCT00552253` - Levothyroxine Treatment in Thyroid Benign Nodular Goiter	N/A
Not yet recruiting	`NCT03700762` - Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
Enrolling by invitation	`NCT01757834` - Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules	N/A
Completed	`NCT01292044` - The Role of Elastography in the Diagnosis of Thyroid Nodules	N/A
Completed	`NCT00858104` - Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results	Phase 4
Completed	`NCT00651625` - Reciprocating Medical Devices - a Study of a New Safety Device	N/A
Completed	`NCT05132478` - The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Oxidized Cellulose Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms