PD Dr. Matthias Korell
Gynaecology Head of the department: PD Dr. Matthias Korell Fone: 0049 203 733 2200 Fax: 0049 203 733 2202 eMail: m.korell@t-online.de
Significant Clinical Result in the Treatment of Adhesions with the SprayGel Adhesion Barrier
http://www.spraygel.com/spraygel/significant.htm
German Case Provides Freedom from Pain for the First Time in 22 Years for a Canadian Woman
Waltham, MA (USA), April 24, 2002: Confluent Surgical, Inc. announced today that the SprayGel Adhesion Barrier, their flagship product, exceeded the clinical expectations of a leading German gynecologic surgeon in the treatment of a patient suffering from adhesion-related pain for twenty-two years.
Matthias Korell, MD, Privat Dozent of Gynecological Surgery, Duisburg, Germany, is recognized for his expertise in preventing and reducing adhesions in the abdomen and pelvis that result from previous open or laparoscopic surgical intervention. "The SprayGel Adhesion Barrier exceeded my expectations in reducing adhesions and represents a big step forward in treating patients with adhesion-related pain," says Dr. Korell. "We could see a complete adhesion-free abdominal wall one week after performing adhesiolysis." Adhesiolysis is the surgical removal of adhesions. "Having treated this patient since July 2000 for adhesion-related pain, this is the first and only time that significant improvement from pain has been recognized."
The patient, a Registered Nurse and mother of six from Calgary, Alberta (Canada), has had over twenty abdominopelvic surgeries in the last twenty-two years. As a direct result of these surgeries, she had developed adhesions. These adhesions severely impacted her lifestyle as evidenced by her inability to lie down or raise her arms above her head without pain. "The pain controlled my life, resulting in the loss of my job and dramatic feelings of isolation. Other products for adhesion reduction have been used during my past surgeries, but the pain would return in two to three days," said the patient. Eight days after Dr. Korell's use of the SprayGel Adhesion Barrier, she refers to her case as "a miracle - I feel very good with an overall sense of wellness and, for the first time in years I have complete mobility without pain."
Dr. Korell further stated, "there is no risk of the development of severe adhesions unless she has another traumatic surgery. While this case is of an extreme nature, the performance of the SprayGel Adhesion Barrier supports the benefits of the prevention and reduction of adhesions in routine gynecological surgery that may result in adhesion formation."
Adhesions and fibrous bands of tissue between adjacent organs of the body are typically caused by surgery and are directly related to pain. Adhesions can start to form within three hours after surgery and will cease forming when the sites of surgery heal, typically within seven days following surgery. It is estimated that adhesions affect over five million women and men worldwide and that the global market potential for total abdominopelvic adhesion management is estimated at approximately $2.6 billion (US).
Evidence of adhesion prevention and reduction is discovered when a surgeon takes a second look at the surgical site through a laparoscope, an instrument used to perform less-invasive surgery.
Amar S. Sawhney, Ph.D., founder, President and CEO of Confluent Surgical, Inc., said, "we are very pleased with our clinical results in Europe to date and believe that cases such as Professor Korell's represent additional evidence that differentiates the SprayGel Adhesion Barrier from all other adhesion barrier products on the market today."
The SprayGel Adhesion Barrier received CE mark in November 2001, and has been introduced in major markets in Europe. Based on a European clinical study, the patented and proprietary synthetic material of the SprayGel Adhesion Barrier has been shown to reduce or eliminate adhesion formation following abdominopelvic surgery. The SprayGel Adhesion Barrier is not commercially available in the United States.
Confluent Surgical, Inc. is a privately held company developing products based on its platform of in-situ polymerized biomaterials and associated delivery systems. For more information please contact Roberta Sawyer at rsawyer@confluentsurgical.com or visit the Confluent Surgical website at www.confluentsurgical.com.
Abstract No: 78
ADHESION PREVENTION IN ENDOSCOPIC SURGERY WITH SPRAYGELM. Korell
Dept. of OB/GYN Klinikum Duisburg Zu Den Rehwiesen, Germany
http://www.comtecmed.com/cogi/cogi3/abstracts/78.doc
Introduction: Adhesions are very common after nearly every type of intraabdominal surgery and can lead to severe problems like sterility, pain or even life threatening bowel obstruction. Many different agents for adhesion prevention are studied, but failed to show efficacy in clinical routine. Recently a new product SprayGel - based on polyethylene glycol (PEG) - is available for endoscopic use. We have investigated the results of SprayGel in patients with high risk for postoperative adhesions. Method: 37 patients with extensive adhesions (n=17), severe endometriosis (n=16) and/or uterine myomas (n=14) underwent endoscopic surgery in our departement. At the end of the intervention SprayGel was placed on the area of serosal defect respectively arround the suture. The results were examined during second look laparoscopy 1-4 weeks postoperatively. The findings were scored in no, mild or severe adhesions. Results: There were no side effects or complication of the SprayGel use. Until now, we could perform second look laparoscopies in 34 patients. In 14 cases, no adhesions were found. In 13 respectively 7 patients we have seen mild respectively severe adhesions. Conclusion: In respect to the severity of the treated cases the results of SprayGel are very promising. The specific advantages over the currently available barrier methods are a site specific effect, the lack of drug reaction and the ease of use. Prospective randomized trials to clarify the efficacy of SprayGel are planned.
Experimental animal model for readhesion formation study.J Invest Surg. 1994 Sep-Oct;7(5):409-15. PMID: 7841162 [PubMed - indexed for MEDLINE]
Korell M, Scheidel P, Hepp H.
Photodynamic therapy of vulvar lichen sclerosus with 5-aminolevulinic acid.Obstet Gynecol. 1999 Jan;93(1):71-4. PMID: 9916959 [PubMed - indexed for MEDLINE]
Hillemanns P, Untch M, Prove F, Baumgartner R, Hillemanns M, Korell M
Detection and mapping of intraabdominal adhesions by using functional cine MR imaging: preliminary results.Radiology. 2000 Nov;217(2):421-5. PMID: 11058638 [PubMed - indexed for MEDLINE]
Lienemann A, Sprenger D, Steitz HO, Korell M, Reiser M.
Clinical evaluation of a viscoelastic gel for reduction of adhesions following gynaecological surgery by laparoscopy in Europe.Hum Reprod. 2005 Feb;20(2):514-20. Epub 2004 Dec 9. PMID: 15591082 [PubMed - indexed for MEDLINE]
Lundorff P, Donnez J, Korell M, Audebert AJ, Block K, diZerega GS.
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