News Release

Laparoscopic surgery does not reduce adhesions in gynaecological procedures

Infertility risk maintained

Peer-Reviewed Publication

Resolute Communications

New 24,000 patient epidemiological study explodes myth that 'keyhole' surgery is less likely to cause adhesions than open surgery

Madrid, Spain - 01 July 2003 - New epidemiological research involving more than 24,000 patients in Scotland* has found that women undergoing common gynaecological procedures involving laparoscopic (keyhole) surgery are just as likely to be re-admitted for treatment of surgery-related adhesions as those treated using standard open surgical techniques.1 93% of people undergoing abdominal surgery develop adhesions2, which are implicated in up to 20% of cases of secondary infertility3. The aim of the research was not only to compare the rates of adhesion-related readmissions for laparoscopic and open surgery, but to assess what impact advances in surgery have had on adhesion-related outcomes since 1986.

The SCAR2 feasibility study, presented today at the Annual Meeting of the European Society of Human Reproduction and Embryology was designed to follow in the footsteps of the groundbreaking SCAR study4, which examined the burden of adhesion-related readmissions over ten years following gynaecological and lower abdominal laparotomies (open surgery) in 1986. At the time of that original research, laparoscopic surgery was in its relative infancy and adhesion-related admission data for this type of procedure were not included. For the new study, researchers identified all gynaecological surgeries (laparotomies and laparoscopies) carried out over a twelve-month period (April 1996 - March 1997) and then tracked all readmissions in the subsequent four years.

"Many surgeons and gynaecologists hoped that less invasive surgery using laparoscopic techniques could reduce the risk of adhesions and their complications, something which is particularly important for women, given the associated risk of infertility", said Mr Adrian Lower, principal investigator and consultant gynaecologist based at the London Clinic.

"What our research shows, however, is that adhesion prevention strategies must be adopted even during laparoscopic procedures since in many gynaecological procedures re-admission due to adhesion-related complications was just as common as with open surgery," continued Mr Lower.

In total, 15,197 women undergoing laparascopic procedures and 8,849 women undergoing laparotomy procedures were identified. The researchers found that for laparoscopic sterilisation procedures the risk of an adhesion-related readmission was very low. However, for other laparoscopic procedures - which make up over 40% of gynaecological laparoscopies undertaken in Scotland and were undergone by 6, 276 women in this study - the risks of adhesion related readmissions are significant.

Laparoscopic (keyhole) surgery
Type of Surgery Definite Readmission Risk
Adhesiolysis or adhesion-related procedure within 1 year of laparoscopy
Possible Readmission Risk
Possibly due to adhesions within 1 year of laparoscopy
Low Risk
Fallopian tube / sterilisation procedures
1 in 500 1 in 40
Medium / High Risk
Therapeutic/diagnostic procedures & adhesiolysis
1 in 70 / 1 in 80 1 in 10 / 1 in 7

As far as traditional laparotomy surgery is concerned, the new research confirmed the findings of the original SCAR study, in that the burden of adhesion-related readmissions remains a significant problem, with operations on the ovary and Fallopian tubes carrying the highest risk of readmission.

Laparotomy (open) surgery
Type of Surgery Definite Readmission Risk
Adhesiolysis or adhesion-related procedure within 1 year of laparoscopy
Possible Readmission Risk
Possibly due to adhesions within 1 year of laparoscopy
Uterine surgery 1 in 170 1 in 20
Fallopian tube surgery and ovarian surgery 1 in 120 / 1 in 50 1 in 7 / 1 in 6

"As surgeons, we know that using adhesion reduction strategies can reduce the risk of post-operative complications. Given the scale of the problem and the impact we know that adhesions can have upon our patients' lives, we must continue to do everything we possibly can to prevent adhesions as part of good surgical technique. For surgical procedures with a known risk of adhesion-related problems this means we should be considering routine use of adhesion-prevention therapies," concluded Mr Lower.

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For further information please contact Resolute Communications:

Onsite: Anna Korving: 44-7710-420-523 or Julia Clough: 44-7967-738-257
In London: Sarah Pracey or Monica Shuman: 44-207-357-8187

Notes to Editors

Preventing adhesions: A number of physical barriers have been developed for use during surgery to help prevent adhesions. However, these have had limited uptake in open surgery and are generally difficult to use in laparoscopic surgery. One key challenge is that these physical barriers (gels, sprays or film-like sheets placed between neighbouring organs in the peritoneal cavity) may reduce adhesions where they are placed, but do not prevent adhesions developing elsewhere in the abdomen. The ideal adhesion-reduction agent should be easy to use in all types of surgical procedure and capable of reducing adhesion formation at the operating site and throughout the peritoneum. Ongoing research suggests that Adept® (icodextrin 4%) may be closest to this ideal profile. A non-viscous liquid, Adept can be used for both open and laparoscopic surgery, and is compatible with a wide range of antibiotics used during and after surgery. Adept is simple to use, being instilled slowly at the end of surgical procedures and used during surgery as an irrigant. A 1.5 litre bag of Adept (enabling 500ml to be used during procedures with 1000ml remaining for instillation at the end of surgery) costs £44.00.

*The Scottish morbidity record system was used as the basis for both the SCAR2-feasibility study and the original SCAR study in 1986. It was selected because it is a robust system to track the progress of patients through the health service.

Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international emerging pharmaceutical company with a strategic focus on four therapeutic areas - central nervous system disorders (CNS), gastrointestinal (GI), oncology, and anti-infectives. Shire also has three platform technologies: advanced drug delivery, lead optimisation for small molecules and Biologics. Shire's core strategy is based on research and development combined with in-licensing and a focus on key pharmaceutical markets. For further information on Shire, please visit the company's website: www.shire.com

References:
1. Adhesion-related readmissions following gynaecological laparoscopy or gynaecological laparotomy in Scotland. An epidemiological study of 24,046 patients. A Lower, R Hawthorn, D Clark, A Knight and A Crowe on behalf of the SCAR panel. Presented at the 19th Annual Meeting of the European Society of Human Reproduction and Embryology, Madrid, Spain, 1 July 2003.
2. Menzies D, Ellis H. Intestinal obstruction from adhesions - how big is the problem? Ann R Coll Surg Engl 1990; 72:60-3
3. Hershlag A, Diamond MP, DeCherney AH. Adhesiolysis. Clin Obstet Gynecol 1991; 34: 395-402
4. Lower AM, Hawthorn RJS, Ellis H et al. The impact of adhesions on hospital readmissions over ten years after 8489 open gynaecological operations: an assessment from the Surgical and Clinical Adhesions Research Study. Br J Obstet Gynaecol. 2000; 1071.(7): 855-862.


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