B9-3, Hi-Tech
Medical Device Park
Wuhan 430206
Tel: +86 27 87880126
Fax: +86 27 87880126



Effect on hemostasis of an absorbable hemostatic gelatin sponge after transrectal prostate needle biopsy

2016-05-16 / Categories:hemostatic, sponge,
The utility of the absorbable hemostatic gelatin sponge for hemostasis in anorectal surgery has been reported (1, 2). While the gelatin sponge can be expected to promote hemostasis in rectal bleeding, there are no studies evaluating its efficacy on hemostasis in transrectal ultrasound-guided prostate biopsy.


To clarify the efficacy on hemostasis of the gelatin sponge for rectal bleeding in transrectal ultrasound-guided prostate biopsy in a randomized controlled prospective study.


This prospective study was approved by the ethical committee at Hiroshima City Asa Hospital. From October 2011 to November 2012, after informed consent, a total of 278 participants were submitted to a transrectal ultrasound-guided prostate biopsy with an 18G×200mm biopsy needle under local anesthesia (chloride 1% lidocaine in the rectal membrane) by the same surgeon (K.K). For those participants taking antiplatelet agents, the medication was discontinued before the biopsy for an appropriate period until the antiplatelet drug was eliminated from the body, e.g. 14 days for clopidogrel bisulfate and 4 days for warfarin.

Before the biopsy, all the participants were randomly assigned to two groups by the envelope method; gelatin sponge (SPONGOSTANTM Anal, Ethicon, Inc., Johnson & Johnson, USA, Figure-1) insertion immediately after the biopsy (group A, n=148) and no insertion (group B, n=130). In both groups, no medical procedures, such as a digital rectal examination (DRE), were done. The patients stayed in the hospital at least one day for observation of their postsurgical course by the medical staff, and this 24 hour observation period excluded as much as possible any bias in this study. The hematological value, IPSS (International Prostate Symptom Score), QoL (Quality of Life) score, OABSS (Over Active Bladder Symptom Score), and a questionnaire that was composed of 6 items with 5 levels of response (Appendix) were evaluated in both groups. Figure-2 shows the flowchart of this study.

For both groups, when blood was observed on the underwear or in the bedpan after the biopsy, the DRE was performed to confirm the degree of bleeding. If attached blood on the DRE was marginal and the color was pink or dilute red, we decided that additional measures were unnecessary. If there was considerable attached blood or blood clots, we defined it as significant rectal bleeding. We categorized significant rectal bleeding into two grades for hemostasis management, including mild (slight or moderate bleeding) and severe (profuse bleeding that required endoscopic clipping). When the bleeding was classified as mild, we inserted the gelatin sponge into the participants in either group B or reinserted it into those participants in group A. If the bleeding could not be stopped by this approach, we additionally used index finger pressure for ten minutes or more to promote hemostasis. In the severe cases, an endoscopic clipping was performed to control the bleeding because arterial bleeding was suspected. Those severe cases were given bed rest until the next morning after the prescript hemostatic approach.