Combined Hemostasis and Adhesion Prevention with the Novel Agent 4DryField® PH—Initial Observations
Author(s)
Matthias Korell
ABSTRACT
Large size peritoneal trauma from extended surgery for high-grade expansive uterus pathology or endometriosis might result in severe diffuse bleeding and peritoneal adhesion formation with objectionable sequelae. This paper introduces 4DryField® PH polysaccharide powder certified for two indications: 1) given as powder 4DryField® PH provides hemostasis; 2) transformed into gel, 4DryField® PH forms an adhesion prevention barrier. Twenty-one women with expanded uterus pathology and/or deep infiltrating endometriosis had surgery including repair of intestine lesions (n = 8), ureterolysis/repair of bladder, including retrograde ureteric stents (n = 5). Subjective impression of hemostatic effect, drain loss and infection parameters were recorded. Six women had scheduled second look laparoscopy. 4DryField® PH applied as powder showed an immediate significant hemostatic effect in all instances, especially in profound diffuse bleeding. Mean drain loss was 497 ± 339 mL, moderate considering the extent of disease. Dripped with saline solution, 4DryField® PH immediately formed a viscous gel acting as a barrier for adhesion prevention. Second look laparoscopy revealed only one patient with significant adhesions. No adverse events were observed; discharge was at Day 6.2 ± 1.4. In this cohort with extended gynecological laparoscopic surgery 4DryField® PH was very effective for hemostasis. The results of second look laparoscopies showed mainly no or minor adhesions. This can be considered very favorable regarding the extent of disease in these patients. Considering the twofold effect in hemostasis and adhesion prevention, 4DryField® PH is a very helpful tool especially in extensive and complicated surgeries. Prospective randomized studies are necessary to prove these promising results in larger series.
Large size peritoneal trauma from extended surgery for high-grade expansive uterus pathology or endometriosis might result in severe diffuse bleeding and peritoneal adhesion formation with objectionable sequelae. This paper introduces 4DryField® PH polysaccharide powder certified for two indications: 1) given as powder 4DryField® PH provides hemostasis; 2) transformed into gel, 4DryField® PH forms an adhesion prevention barrier. Twenty-one women with expanded uterus pathology and/or deep infiltrating endometriosis had surgery including repair of intestine lesions (n = 8), ureterolysis/repair of bladder, including retrograde ureteric stents (n = 5). Subjective impression of hemostatic effect, drain loss and infection parameters were recorded. Six women had scheduled second look laparoscopy. 4DryField® PH applied as powder showed an immediate significant hemostatic effect in all instances, especially in profound diffuse bleeding. Mean drain loss was 497 ± 339 mL, moderate considering the extent of disease. Dripped with saline solution, 4DryField® PH immediately formed a viscous gel acting as a barrier for adhesion prevention. Second look laparoscopy revealed only one patient with significant adhesions. No adverse events were observed; discharge was at Day 6.2 ± 1.4. In this cohort with extended gynecological laparoscopic surgery 4DryField® PH was very effective for hemostasis. The results of second look laparoscopies showed mainly no or minor adhesions. This can be considered very favorable regarding the extent of disease in these patients. Considering the twofold effect in hemostasis and adhesion prevention, 4DryField® PH is a very helpful tool especially in extensive and complicated surgeries. Prospective randomized studies are necessary to prove these promising results in larger series.
Cite this paper
Korell, M. (2014) Combined Hemostasis and Adhesion Prevention with the Novel Agent 4DryField® PH—Initial Observations. Surgical Science, 5, 533-539. doi: 10.4236/ss.2014.512081.
Korell, M. (2014) Combined Hemostasis and Adhesion Prevention with the Novel Agent 4DryField® PH—Initial Observations. Surgical Science, 5, 533-539. doi: 10.4236/ss.2014.512081.
References
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http://dx.doi.org/10.1007/s00404-014-3312-7 [7] Menzies, D. and Ellis, H. (1990) Intestinal Obstruction from Adhesions—How Big Is the Problem? Annals of the Royal College of Surgeons of England, 72, 60-63. [8] Di Zerega, G.S. (2000) Peritoneum, Peritoneal Healing, and Adhesion Formation. In: Di Zerega, G.S., Ed., Peritoneal Surgery, Springer New York, New York, 3-37. http://dx.doi.org/10.1007/978-1-4612-1194-5_1 [9] Di Zerega, G.S., Roth, R. and Johns, D.B. (2003) Quantitation of Peritoneal Adhesions and Correlation with Clinical Outcomes. Infertility and Reproductive Medicine Clinics of North America, 14, 431-456. [10] Hanke, A.A., Flaricke, F., Sieg, L., Johanning, K. and Rahe-Meyer, N. (2011) Effects of a New Microporous Polysaccharide Powder on Viscoelastic Characteristics of Clot Formation. American Society of Anesthesiologists Annual Meeting 2011. Anesthesiology. [11] Poehnert, D., Abbas, M., Kreipe, H., Klempnauer, J. and Winny, M. (2014) Marked Reduction of Peritoneal Adhesion Formation in Rat Model of Cecal Abrasion by a Novel Anti-Adhesive Agent, 4DryField® PH: 131st Congress of the German Society for Surgery. Langenbeck’s Archives of Surgery, 399, 371-413. [12] Donnez, J., Squifflet, J. and Donnez, O. (2009) Have the Safety Concerns about Laparoscopic Hysterectomy Been Fully Addressed? BJOG: An International Journal of Obstetrics & Gynaecology, 116, 1272-1273. http://dx.doi.org/10.1111/j.1471-0528.2009.02253.x [13] Kavic, S.M. and Kavic, S.M. (2002) Adhesions and Adhesiolysis: The Role of Laparoscopy. JSLS Journal of the Society of Laparoendoscopic Surgeons/Society of Laparoendoscopic Surgeons, 6, 99-109. [14] Ray, N. (1998) Abdominal Adhesiolysis: Inpatient Care and Expenditures in the United States in 1994. Journal of the American College of Surgeons, 186, 1-9.
http://dx.doi.org/10.1016/S1072-7515(97)00127-0 [15] Tingstedt, B., Isaksson, J. and Andersson, R. (2007) Long-Term Follow-Up and Cost Analysis Following Surgery for Small Bowel Obstruction Caused by Intra-Abdominal Adhesions. British Journal of Surgery, 94, 743-748. http://dx.doi.org/10.1002/bjs.5634 [16] Lower, A.M., Hawthorn, R.J.S., Clark, D., et al. (2004) Adhesion-Related Readmissions Following Gynaecological Laparoscopy or Laparotomy in Scotland: An Epidemiological Study of 24,046 Patients. Human Reproduction (Oxford, England), 19, 1877-1885. http://dx.doi.org/10.1093/humrep/deh321 [17] ten Broek, R.P.G., Issa, Y., van Santbrink, E.J.P., et al. (2013) Burden of Adhesions in Abdominal and Pelvic Surgery: Systematic Review and Met-Analysis. BMJ, 347, f5588.
http://dx.doi.org/10.1136/bmj.f5588
[1] Chelmow, D., Aronson, M.P., Wosu, U., DeCherney, A.H., Goodwin, T.M. and Laufer, N. (2007) Intraoperative and Postoperative Complications of Gynecologic Surgery. Current Diagnosis & Treatment: Obstetrics & Gynecology. 10th Edition, McGraw-Hill Medical, New York. [2] Makinen, J. (2001) Morbidity of 10 110 Hysterectomies by Type of Approach. Human Reproduction, 16, 1473-1478. http://dx.doi.org/10.1093/humrep/16.7.1473 [3] Makinen, J., Brummer, T., Jalkanen, J., et al. (2013) Ten Years of Progress-Improved Hysterectomy Outcomes in Finland 1996-2006: A Longitudinal Observation Study. BMJ Open, 3, Article ID: e003169. http://dx.doi.org/10.1136/bmjopen-2013-003169 [4] Stang, A., Merrill, R.M. and Kuss, O. (2011) Nationwide Rates of Conversion from Laparoscopic or Vaginal Hysterectomy to Open Abdominal Hysterectomy in Germany. European Journal of Epidemiology, 26, 125-133. http://dx.doi.org/10.1007/s10654-010-9543-4 [5] Hirschelmann, A., Tchartchian, G., Wallwiener, M., Hackethal, A. and de Wilde, R.L. (2012) A Review of the Problematic Adhesion Prophylaxis in Gynaecological Surgery. Archives of Gynecology and Obstetrics, 285, 1089-1097. http://dx.doi.org/10.1007/s00404-011-2097-1 [6] de Wilde, R.L., Bakkum, E.A., Brolmann, H., et al. (2014) Consensus Recommendations on Adhesions (Version 2014) for the ESGE Adhesions Research Working Group (European Society for Gynecological Endoscopy): An Expert Opinion. Archives of Gynecology and Obstetrics, 290, 581-582.
http://dx.doi.org/10.1007/s00404-014-3312-7 [7] Menzies, D. and Ellis, H. (1990) Intestinal Obstruction from Adhesions—How Big Is the Problem? Annals of the Royal College of Surgeons of England, 72, 60-63. [8] Di Zerega, G.S. (2000) Peritoneum, Peritoneal Healing, and Adhesion Formation. In: Di Zerega, G.S., Ed., Peritoneal Surgery, Springer New York, New York, 3-37. http://dx.doi.org/10.1007/978-1-4612-1194-5_1 [9] Di Zerega, G.S., Roth, R. and Johns, D.B. (2003) Quantitation of Peritoneal Adhesions and Correlation with Clinical Outcomes. Infertility and Reproductive Medicine Clinics of North America, 14, 431-456. [10] Hanke, A.A., Flaricke, F., Sieg, L., Johanning, K. and Rahe-Meyer, N. (2011) Effects of a New Microporous Polysaccharide Powder on Viscoelastic Characteristics of Clot Formation. American Society of Anesthesiologists Annual Meeting 2011. Anesthesiology. [11] Poehnert, D., Abbas, M., Kreipe, H., Klempnauer, J. and Winny, M. (2014) Marked Reduction of Peritoneal Adhesion Formation in Rat Model of Cecal Abrasion by a Novel Anti-Adhesive Agent, 4DryField® PH: 131st Congress of the German Society for Surgery. Langenbeck’s Archives of Surgery, 399, 371-413. [12] Donnez, J., Squifflet, J. and Donnez, O. (2009) Have the Safety Concerns about Laparoscopic Hysterectomy Been Fully Addressed? BJOG: An International Journal of Obstetrics & Gynaecology, 116, 1272-1273. http://dx.doi.org/10.1111/j.1471-0528.2009.02253.x [13] Kavic, S.M. and Kavic, S.M. (2002) Adhesions and Adhesiolysis: The Role of Laparoscopy. JSLS Journal of the Society of Laparoendoscopic Surgeons/Society of Laparoendoscopic Surgeons, 6, 99-109. [14] Ray, N. (1998) Abdominal Adhesiolysis: Inpatient Care and Expenditures in the United States in 1994. Journal of the American College of Surgeons, 186, 1-9.
http://dx.doi.org/10.1016/S1072-7515(97)00127-0 [15] Tingstedt, B., Isaksson, J. and Andersson, R. (2007) Long-Term Follow-Up and Cost Analysis Following Surgery for Small Bowel Obstruction Caused by Intra-Abdominal Adhesions. British Journal of Surgery, 94, 743-748. http://dx.doi.org/10.1002/bjs.5634 [16] Lower, A.M., Hawthorn, R.J.S., Clark, D., et al. (2004) Adhesion-Related Readmissions Following Gynaecological Laparoscopy or Laparotomy in Scotland: An Epidemiological Study of 24,046 Patients. Human Reproduction (Oxford, England), 19, 1877-1885. http://dx.doi.org/10.1093/humrep/deh321 [17] ten Broek, R.P.G., Issa, Y., van Santbrink, E.J.P., et al. (2013) Burden of Adhesions in Abdominal and Pelvic Surgery: Systematic Review and Met-Analysis. BMJ, 347, f5588.
http://dx.doi.org/10.1136/bmj.f5588