Gallbladder Removal Performed With New Covidien SILS™ Procedure - Fact Sheet

About Gallstones and Gallbladder Surgery

• Approximately 500,000 gallbladder surgeries or cholecystectomies are performed each year in the United States.[i] <#_edn1>
• Cholecystectomies are performed to address gallbladder pain, gallbladder dysfunction, gallbladder infection and gallbladder tumors.
• The most common reason for cholecystectomies is the removal of gallstones that cause gallbladder pain or biliary colic – blockage of the cystic or bile duct.[ii] <#_edn2>
• Approximately 20 million adults in the U.S. have gallstones.[iii] <#_edn3>
• An estimated one million people are newly diagnosed with gallstones each year.3
• Gallstones are twice as likely to occur in women.[iv] <#_edn4>
• Overweight people, older adults, Native Americans and Mexican Americans are also at greater risk.[v] <#_edn5>
• Symptomatic gallstones may cause severe problems, from biliary pain to potentially life-threatening complications like acute cholecystitis and pancreatitis, or in rare cases gallbladder cancer.3
• Approximately 80 percent of people with gallstones go 20 years or longer without symptoms.3
• Once gallstone symptoms appear, they recur in the majority of patients. Symptomatic patients are 25 percent more likely to develop complications within 10 to 20 years.3
• Gallstones are the most common and most costly digestive disease, with an annual estimated overall cost of more than $5 billion.3
• Performing early laparoscopic cholecystectomy for acute cholecystitis may help to reduce costs by preventing recurrent emergency admissions in these patients.[vi] <#_edn6>
• Hospitalization after cholecystectomy, or gallbladder surgery, is due to the wound caused by the incision, instead of the removal of the gallbladder itself.[vii] <#_edn7>
  

 

General Laparoscopic Surgery

• The first laparoscopic cholecystectomy was performed in 1987.3
• More than 80 percent of all cholecystectomies performed in the U.S. are done laparoscopically.3
• Open cholecystectomies involve a 6-inch long incision vs. four ½-inch or smaller incisions for laparoscopic surgeries.2,3
• In many cases a patient can go home the same day as their surgery, whereas a 3 to 7 day stay is typical with open surgery.3
• Pain and discomfort are more severe in open surgery and mild or minimal in laparoscopic procedures.3
• Major complications are rare (2.1 percent) and conversions to an open procedure are also rare (4.5 percent).[viii] <#_edn8>
• Laparoscopic procedures generally result in better quality-of-life outcomes than open surgery.[ix] <#_edn9>
• Most general laparoscopic cholecystectomy procedures average 90 minutes or less.14
  
  
  

 
The SILS™ Procedure –
Laparoscopic Surgery Using a Single Incision

• SILS™ cholecystectomy was first described in 1997 with favorable outcomes.[x] <#_edn10>
• The SILS™ surgery represents a feasible advanced laparoscopic procedure.  The procedure has the added benefit of a single scar which may be concealed in the umbilicus.[xi] <#_edn11> ,[xii] <#_edn12> ,[xiii] <#_edn13>
• The SILS™ surgery involves a single 20mm incision through the umbilicus (or belly button) compared to the four ½-inch or smaller incisions typically associated with general laparoscopic procedures, minimizing the scars and wound pain that may accompany additional points of entry.
• The SILS™ procedure can be utilized in a wide variety of surgeries including bariatric, urologic and gynecologic.[xiv] <#_edn14> ,[xv] <#_edn15> ,[xvi] <#_edn16> ,[xvii] <#_edn17>
  
  

Postop SILS Cholecystectomy Patient (Gallbladder Removal)

 

[i] <#_ednref> National Digestive Diseases Information Clearinghouse. Digestive Diseases Statistics; NIH Publication No. 06–3873, December 2005. Accessed January 16, 2009.
http://digestive.niddk.nih.gov/statistics/statistics.htm

[ii] <#_ednref> American College of Surgeons Division of Education. Cholecystectomy: Surgical Removal of the Gallbladder. Revised October 6, 2008. Accessed January 16, 2009.
http:// www.facs.org/public_info/operation/cholesys.pdf

[iii] <#_ednref> National Institute of Health. Gallstones and Laparoscopic Cholecystectomy.                                
NIH Consensus Statement, 1992.

[iv] <#_ednref> National Digestive Diseases Information Clearinghouse. Gallstones; NIH Publication No. 07–2897, July 2007. Accessed January 16, 2009.
http://digestive.niddk.nih.gov/ddiseases/pubs/gallstones/index.htm

[v] <#_ednref> National Institute of Diabetes and Digestive and Kidney Diseases. Gallstones; NIH: Medline Plus. Accessed January 16, 2009.
http://www.nlm.nih.gov/medlineplus/gallstones.html

[vi] <#_ednref> Somasekar, K. Costs of Waiting for Gallbladder Surgery. Postgraduate Medical Journal, November 2002.

[vii] <#_ednref> Mack, M. Minimally Invasive and Robotic Surgery. JAMA, 2001.                              
http://jama.ama-assn.org/cgi/content/full/285/5/568

[viii] <#_ednref> Larson, G. et al. Multipractice Analysis of Laparoscopic Cholecystectomy in 1,983 Patients. Am J Surg, 1992.  

[ix] <#_ednref> Velanovich, V. Laparoscopic vs. Open Surgery. Surgical Endoscopy, January 2000.

[x] <#_ednref> Navarra, G. et al. Short Note: One Wound Laparoscopic Cholecystectomy. Br J Surg, 1997.

[xi] <#_ednref> Tacchino, R. et al. Single-incision Laparoscopic Cholecystectomy: Surgery without a Visible Scar. Surg Endosc, September 2008.

[xii] <#_ednref> Goldsmith, M. Future Surgery: Minimal Invasion. JAMA, 1990.

[xiii] <#_ednref> Soper, N. et al. Comparison of Early Postoperative Results for Laparoscopic versus Standard Open Cholecystectomy. Surg Gynecol Obstet, 1992.

[xiv] <#_ednref> Raman, J. et al. Single-Incision, Umbilical Laparoscopic versus Conventional Laparoscopic Nephrectomy: A Comparison of Perioperative Outcomes and Short-Term Measures of Convalescence. European Association of Urology, August 2008.  

[xv] <#_ednref> Saber, A. et al. Single Incision Laparoscopic Sleeve Gastrectomy (SILS): A Novel Technique. Obesity Surgery, 2008.

[xvi] <#_ednref> Raman, J. et al. Single-incision Laparoscopic Surgery: Initial Urological Experience and Comparison with Natural-orifice Transluminal Endoscopic Surgery. BJU International, 2008.

[xvii] <#_ednref> Kaouk, J. et al. Single-port Laparoscopic Surgery in Urology: Initial Experience. Urology, January 2008.