Table 2.
Summary of Key Information from Included Studies Categorized by Type of Topical Hemostatic Agent
| Type of Product | Type of Study | Number of Patients | Type of Procedure | Major Findings (p value) | Quality |
|---|---|---|---|---|---|
| Fibrin Sealant | Case-Control (Angioli et al., 2012) | N = 30 | Laparoscopic myomectomy | Reduction in blood loss with fibrin sealant (Tisseel®) was significant (p < .05) | Fair Potential confounders not addressed |
| Less decrease in post-operative hemoglobin with fibrin sealant (Tisseel®) was significant (p < .05) | Specific inclusion criteria stated | ||||
| Decreased time to hemostasis with fibrin sealant (Tisseel®) was significant (p < .0005) | Good follow-up | ||||
| Reduction in operative time with fibrin sealant (Tisseel®) was significant (p < .0005) | |||||
| Prospective Cohort* (Kang et al., 2015) | N = 129 | Laparoscopic ovarian cystectomy | Significantly less decline in AMH with use of fibrin sealant (TachoSil®) or thrombin/gelatin matrix (Floseal®) vs. bipolar energy (p = .003) | Fair | |
| No significant differences in AMH when comparing fibrin sealant(TachoSil®) vs.thrombin/gelatin matrix (Floseal®) (p = .962) | Good sample size No sample size calculation No discussion of how patients were divided among treatment arms |
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| Thrombin Gelatin Matrix | Prospective Cohort (Angioli et al., 2009) | N = 20 | Laparoscopic excision of ovarian endometrioma | Time of hemostasis in thrombin/gelatin matrix (Floseal®) group was shorter but not statistically significant when compared with bipolar energy (p = .19) | Fair |
| Average blood loss in thrombin/gelatin matrix group was less but not statistically significant (p = .373) | Small sample size | ||||
| Operating time was not significantly longer in thrombin/gelatin matrix group (p = .334) No post-operative transfusions needed |
Potential confounders not addressed | ||||
| Prospective Cohort* (Kang et al., 2015) | N = 129 | Laparoscopic ovarian cystectomy | Less decline in AMH with use of thrombin/gelatin matrix (Floseal®) or fibrin sealant (TachoSil®) vs. bipolar energy was significant (p = .003) | Fair | |
| No significant differences in AMH when comparing fibrin sealant(TachoSil®) vs.thrombin/gelatin matrix (Floseal®) (p = .962) | Good sample size No sample size calculation No discussion of how patients were divided among treatment arms |
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| Prospective Cohort (Song et al., 2014) | N = 20 | Laparoscopic salpingotomy for tubal pregnancy | Achievement of hemostasis in 95% of cases | Poor No sample size calculation Single surgeon experience Concomitant use of vasopressin for hemostasis One case excluded with conversion to salpingectomy Lack of fertility follow-up Lack of comparison/control group |
|
| Randomized Control Trial (Song et al., 2014) | N = 100 | Laparoscopic ovarian cystectomy via single-site approach | Significantly less decline in AMH with use of thrombin/gelatin matrix (FloSeal®) vs. bipolar energy (p = .004) | Good Appropriate Randomization Outcomes assessed reliably Good sample size Multicenter study Standardized surgical approach (SS) Good follow-up |
|
| Prospective Randomized, Pilot Study (Sonmezer et al., 2013) | N = 30 | Laparoscopic excision of ovarian endometrioma | The mean serum AMH in the thrombin/gelatin matrix group after one month was higher than in the bipolar energy group (2.72 ± 1.49 vs. 1.64 ± 0.93 ng/mL) | Good | |
| Percentage changes in serum AMH b/w pre-operative and post-operative month 1 higher in bipolar energy group compared to thrombin/gelatin matrix (p = .001) | Appropriate randomization | ||||
| Percent changes between preoperative and post-operative month 3 serum AMH was not significantly different among the two groups (p = .467) | Outcomes assessed reliably Good follow-up Addressed other studies investigating AMH levels and ovarian damage |
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| Oxidized Regenerated Cellulose | Prospective Cohort (Sharma et al., 2003) | N = 28 | Laparoscopic sterilization | Achievement of hemostasis in 92.8% of patients | Poor Small sample size Potential confounders not addressed Lack of control/ comparison group |
| Prospective Cohort (Sharma et al., 2003) | N = 30 | Surgical termination of pregnancy and laparoscopic sterilization | Achievement of hemostasis in 93.3% of patients | Fair Small sample size Lack of control/ comparison group No follow-up for potential complications associated with HA |
*
Same study, but included more than one hemostatic agent. N = sample size; AMH = anti-Mullerian hormone.