Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01756534
Brief 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
Detailed 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:
NCT01756534
Study Brief:
Protocol Section:
NCT01756534