Pilot studies on the effect of fibrin glue on the amount of drainage after thyroidectomy
- Conditions
- Neoplasms
- Registration Number
- KCT0006352
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Between February and December 2020, 72 patients were eligible for inclusion. Of these 72 patients, 31 patients declined to participate or were excluded during the stratified randomization process. The remaining 41 patients were randomly allocated to each group. During the process of stratified randomization, 41 patients were included; 21 in control group and 20 in experimental group. No patients were excluded in the follow-up and data analyses stages. The mean age was 48.9 years with the male/female ratio of 1:3. The random variables (sex, thyroiditis, and BMI) were not statistically different between the two groups. There were also no significant differences between the two groups in terms of tumor/lymph node (LN) stage, numbers of metastatic LNs, number of retrieved LNs, and weight of thyroid (all P > 0.05, respectively). . The primary outcomes, namely total drain volumes and rate of flow of drain fluid in the 12 hours after surgery were both significantly different between the two groups. In the experimental group, the total drain volume and flow rate during the 12 hours were both significantly lower than those in the control group (65.0 mL vs. 47.6 mL p = 0.008; and 2.7 mL/hr vs. 1.8 mL/hr, p = 0.002, respectively). Although the flow rate of drain fluid during the 24 hours after surgery was lower in the experimental group, it did not show a statistical significance (1.6 mL/hr vs. 2.1 mL/hr, P = 0.06). As for the secondary outcomes, symptomatic seroma developed in three patients in the control group and in none of the patients in the experimental group; the difference was not statistically significant (P = 0.232). Three of these patients had greater flow rate during the 24 hours after surgery than others (1.6 mL/hr vs. 2.1 mL/hr, P = 0.013). The volume of aspirate was < 5 mL in all three patients. There was no hematoma formation during hospitalization or at the follow-up visits. Symptomatic seroma at outpatient clinic was related to the amount of drain during the postoperative 12 hours (p = 0.004). In three patients, the amount of drain was 11 mL more than those who did not develop seroma (29.5 vs. 40.6). Among three patients, one was discharged on postoperative day 1 and the others on postoperative day 2. The duration of hospital stay was not statistically different between the two groups (P = 0.414).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 41
1) patients who were scheduled to undergo total thyroidectomy with central compartment neck dissection (CCND); 2) patients older than 20 years; 3) malignancy on fine-needle aspiration cytology or core needle biopsies; 4) normal platelet count = 100,000/mL; and 5) availability of informed consent.
1) age < 20 years or > 65 years; 2) uncontrolled diabetes; 3) on anticoagulation medication; 4) previous thyroid surgery; 5) advanced hepatic or renal disease; 6) cardiovascular disease; 7) on steroid medication; and 8) declination of informed consent.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the drain volume and rate of flow of drain fluid
- Secondary Outcome Measures
Name Time Method symptomatic seroma formation and the duration of hospital stay