StepStep Step Clinical Abstracts 

STEP* - a new step into the abdomen.  

Results of the different studies (477.000 procedures): 

All abstracts listed bellow content the following information:

MORE DETAILS on the STEP products

 Overview of the clinical abstracts

  1. Bhoyrul, Mori, Way
    Radially Expanding Dilation: A Superior Method of Laparoscopic Trocar Access
    Surg Endosc 10: 795-798, 1996
    Surg Endosc 9:227, 1995 (abstract)
    Animal Study
    Prospective, Controlled, Randomized device insertion
    Step defects slit-like and 50% smaller than trocar defects. Less bleeding and more grip with Step cannulas.
    Step defects rarely warrant closure, may reduce incidence of incisional hernias. Radial expansion of tissues with Step reduced bleeding and slippage.
     

  2. Weiner, Wagner
    Dilatationstrokare zur Vermeidung von Trokarkomplikationen im Rahmen Laparoskopischer Hernienoperationen
    Min Inv Chirugie 2, June 1996
    Prospective, non-randomized, controlled, 523 patients: 259 Step , 264 trocars
    No abdominal wall bleeding, bowel perforation or incisional hernia w/ Step vs. 4 cases of bleeding w/trocars. No hernias w/Step , 1 Richter hernia w/trocar. 
    Significant reduction in abdominal wall bleeding and reduction in incisional hernias in the Step group. Smaller peritoneal wound size may also reduce the risk of port-site seeding.
     

  3. Rothenberg
    The Use of Radially Expandable Laparoscopic Access in Pediatric Patients
    Presented at the 5tth International Congress for Endosurgery in Children, May 1996
    Prospective, self-controlled; 50 pediatric patients; Step compared to standard disposable and reusable trocars
    Slippage for standard disposable trocars was 52%, standard re-usables 20%, Step 2% (1 incident). Wound size was dramatically smaller and wounds less painful for Short Step compared to wounds from trocars.
    Step eliminated loss of pneumo and the need for anchoring, reduced incidence of slippage, and left a smaller wound. Stepд offers significant advantages for pediatric patients with smaller abdominal cavities that tolerate less cannula slippage
     

  4. Feste, Bojahr, Turner
    Randomized Trial comparing a Radially Expandable Needle System With Cutting Trocars 
    JSLS 4(1):11-15, 2000
    Presented at AAGL , Nov.1998
    JAAGL 5(3):S12-13 (abstract)
    Prospective, Randomized, Multicenter; 87 patients: 45 Step, 42 trocars
    Step: 1 case of Veress induced abdominal wall bleeding vs. Trocars: 5 incidences of bleeding and 1 bowel perforation. Steppatients reported less pain.
    83% reduction in adverse events using Step, significantly reduced pain at 8, 12 and 24 hours post-op, and shorter OR time (mean=7 minutes). Potential of lower litigation costs using Step.
     

  5. Baggish, Lovins
    The Radial Expanding Cannula and the Conventional Cannula With Sleeve For Operative Laparoscopy
    Presented at the AAGL, Sept. 1996
    Prospective, randomized, single center, 20 patients. (10 per group, Step vs. conventional trocars)
    Pain scores significantly lower in Stepд patients at 24 and 96 hours post op. 3x more bleeding events in trocar group; Significantly higher slippage in trocar group.
    Stepд lowers the incidence of abdominal wall bleeding and reduces post-operative pain. Slippage and loss of pneumoperitoneum are significantly reduced using Step.
     

  6. Yuen, Yim
    Comparison of Radially Expanding Cannulas With Conventional Cutting Tip Cannulas
    JAAGL 5(3), S59, 1998 (abstract)
    Prospective, randomized, double-blind, self-controlled; 26 women, lateral placement only
    Significantly less post-operative pain, duration of pain, and wound induration. Inferior epigastric artery injury with 4 conventional cannulas, none with Stepд.
    REA system (Stepд) is associated with lower complication rates, less pain, and better cosmetic results than conventional trocars.
     

  7. Applegate, Galen, Steffes, Westerhout
    A Retrospective Study Comparing a Radially Expandable Laparoscopic Access Device With Conventional Trocars
    Presented at the 1996 ISGE & 1996 Pacific Coast Fertility Society Meetings.
    Retrospective, controlled, 98 patients: 136 Stepdevices, 148 conventional trocars
    No bleeding events with Step. 10 incidents of abdominal wall bleeding in the trocar group. Less than 4% of defects from 10mm or 12mm Stepdevices required closure. Surgery time was 21.5 minutes shorter in Stepgroup.
    Significant (>90%) reduction in device complications (including slippage), shorter OR time, and procedure cost savings ranging from $345-$575 using Step.
     

  8. Turner
    A New Radially Expanding Access System For Laparoscopic Procedures Versus Conventional Cannulas
    JAAGL 3:609-615,1996.
    Presented at the 1996 ISGE meeting.
    Prospective, Randomized, Self-Controlled; 19 patients
    No complications using Stepvs. 5 complications using cutting trocars (2 cases of bleeding, 3 cases of cannula slippage). Post- op incisional pain was significantly lower in Stepд group
    REA (Step) system is associated with a lower rate of complications and improved patient comfort compared to traditional cannulas/trocar systems
     

  9. Galen, Jacobsen, Weckstein, Kaplan, DeNevi
    Reduction of Cannula-Related Laparoscopic Complications Using a Radially Expanding Access Device
    JAAGL 6(1):79-84, 1999
    Presented at the AAGL Meeting, 1998;
    Prospective, Multicenter, Data Collection, Steponly; 212 patients, 541 Step cannulas
    No major abdominal wall bleeding, intestinal, bladder, ureteral or liver injuries; no post-op incisional hernia; one Veress needle injury that caused post-op mesenteric hematoma. 
    Based on a comparison to the literature, there was a significant reduction in the most common access-related laparoscopic complications compared to using trocars. This data shows improved patient outcomes that may lessen physician liability and decrease costs.
     

  10. Galen, Jacobsen, Weckstein, Kaplan, DeNevi
    Virtual Elimination of Trocar-Related Laparoscopic Complications Using Radially Expanding Access Devices
    Presented at the World Congress of Gynecologic Endoscopy, 1997.
    2 Arm study: Arm I-Retrospective, Controlled; Arm II-Prospective, Step-only; total (both Arms) 284 patients, 530 Step devices, 255 trocars
    Arm I: Statistically significant reduction in complication rates (p<0.005) and surgical time (p<0.0021) using Step. Arm II: No abdominal wall bleeding, bowel or bladder injuries, no post- op incisional hernias.
    This study offers compelling data showing reduced patient risks and complications associated with the Step System.
     

  11. Bhoyrul , Payne, Steffes, Swanstrom, Gantert, Way
    A Randomized Prospective Study of Radially Expanding Trocars
    J Gastrointest Surg June, 2000. SSAT poster presentation, 1997. Presented at the Congress of Endoscopic Surgery, 1997.
    Prospective, Randomized, Multicenter, 244 patients: 119 Step, 125 trocars
    No bleeding episodes w/Step vs. 16 bleeding episodes in 13 patients that received trocars. Hematoma formation and post-operative pain at the wound site was lower in Steppatients. 
    3% closure of Step defects.
    Intraoperative and post-operative abdominal wall bleeding is significantly lower using Step. Patients in the Stepgroup generally experienced lower pain compared to the trocar group. 
    Stepд defects did not require routine closure w/ no increase in post-op hernia.
     

  12. Davidson, Goldfarb
    Operative Laparoscopy Complicated By Factor VII Deficiency
    JAAGL Vol. 5, No.3,
    Supplement, Aug.1998
    Case report
    The Stepд access system allowed gentle displacement of vascular structures avoiding complications in this patient.
    The less traumatic access system (Step) should be considered if either primary or secondary coagulopathies may be anticipated
     

  13. Mettler, Maher
    Investigation of the Effectiveness of the Radially Expanding Needle System in Contrast to the Cutting Trocar in Enhancing Patient Recovery
    Presented at the ISGE Meeting, 1999
    100 GYN patients randomized to all Step (49 patients.) or all trocars (51 patients.)
    No bleeding events in Step group, 2 bleeding events in trocar group. Statistically lower pain scores @ 4, 8, and 12 hours post-op (p=0.05) in Step patients.
    Compared to the cutting trocar, Step provides statistically improved patient postoperative comfort.
     

  14. Rothenberg, DeCou, Downey, Lelli, Raschbaum
    A Clinical Evaluation of the Use of Radially Expandable Laparoscopic Access Devices in the Pediatric Population
    Presented at the IPEG Meeting, 1999
    Retrospective, Step only; 1021 pediatric patients, 3480 Step devices inserted.
    No major vascular or visceral injuries, rate of slippage. 0.17%, port site bleeding <0.1%; one incisional hernia in 6 mo. old infant (<0.03% of defects), >75% of fascial defects not closed.
    Step allows for safe access even in small neonates, nearly eliminates cannula slippage, and diminishes the risk of trocar injury and trocar site complications.
     

  15. Turner 
    Radially Expanding Access System Is Setting New Standards For Safety, Efficiency, Diminished Pain, and Hernia Formation
    Presented at the AAGL 1998 and the ISGE 1999 Meetings.
    Retrospective review of over 4000 Step cases and all published studies regarding Step used alone or in control trials with conventional trocars.
    Significant decrease in complications when compared to the expected incidence or in direct comparison with trocars. An adverse event for trocar group was 10 times that of Step group
    The Step system provides far safer access compared to conventional trocars. Studies show that operative time and immediate post-operative discomfort are reduced with the Step system.

     

  16. Turner, Feste, Steege, Bojhar
    An Alternative Entry Technique In High-Risk Patients
    Presented at the AAGL 1997, ISGE 1999 and SLS/Endo Expo 1999 Meetings.
    100 patients at high risk for laparoscopy. Left upper quadrant insertion of scope through Step sleeve.
    57% of patients would have been at high or moderate risk of injury to the bowel or vessels with an umbilical entry of a trocar.
    MiniStep sleeve insertion at the LUQ provided easy access. All patients would have otherwise been candidates for Hasson entry due to high risk of umbilical trocar entry.
     

  17. Turner, Galen
    The Radially Expanding Access System
    Presented at the Middlesbrough Consensus Meeting on Laparoscopic Entry Techniques, 1999.
    Data on Step (3012 procedures, 40 centers, 4 years) was compared to the published literature on trocar injuries.
    Trocars have a relative risk of causing serious injury ranging from 4.0-13.1 when compared to Step. Pooled controlled studies showed a 10:1 risk for trocar injury compared to Step.
    Safety and efficacy information on more than 3000 cases showed that Step provides safer access, lower OR time, and reduced post op discomfort.
     

  18. Safadi, Gantert, Duh, Way
    A New Method For Initial Trocar Placement For Laparoscopy Using the Step Device.
    Presented at the EAES Meeting, 1999.
    Technique paper describing umblical insertion of the Step sleeve as an alternative to the Hasson technique.
    2mm incision in peritoneum with expandable sleeve insertion created smaller defect, secure placement, and eliminated use of the Veress needle.
    This technique is as safe as the Hasson technique and has added advantage of smaller port site with no slippage or leakage of pneumoperitoneum. 
     

  19. Less Painful Surgery Still Risky Detroit Free Press, Page 3A, March 27, 1999. Lay article describing laparoscopic complications and the potential for reduction using Step 22 deaths (1994-1997) during laparoscopic surgery were associated with trocars. No equipment replaces proper technique, but better equipment helps to lower rate of injuries during laparoscopy. InnerDyne received additional FDA safety claims for the Step system.
     

  20. Schulam, Hedican, Docimo
    Radially Dilating Trocar System 
    Urology 54: 727-729, 1999 
    14 pediatric patients undergoing laparoscopic procedures using Step Laparoscopic access quick and without complication using Step sleeve & drop in technique. 
    Preferred method of "open" access over Hasson approach. Minimal incisions, superior fascial sealing, easy "up-sizing", safe and rapid access.
     

  21. Reik, Bachman, Galselman, Fischer, Raestrup, Buess, Bartzke
    Veress needle With Optical Protective Shield and Step System: A New Safety Concept In Minimally Invasive Surgery 
    Min Invas Ther & Allied Technol 8(4):245-254, 1999. 
    Animal study: Technique paper describing the use of the Step sleeve in combination with the optical needle. Diagnostic access with the optical veress needle and Step sleeve was less time consuming and made it unnecessary to use classical trocar systems. Diagnostic inspection during insufflation saved time. The effective use of instrumentation in this manner was more cost-effective. Risks were reduced to a minimum since radial dilation was used. Traditional trocar systems no longer required using this method.
     

  22. Daniell, Lalonde, Poblete
    Laparoscopic Use of 12mm Radially Expanding Access Devices To Reduce Abdominal Wall Bleeding Events Presented at the ISGE Meeting, 1995 
    Retrospective; 100 patients: 80 - 12mm trocar controls, 20 - 12mm Step patients; all devices placed lateral to midline 6 minor and 3 major intraoperative bleeding episodes, 2 post op abdominal wall hematomas in 80 patients who received trocars (12%); No abdominal wall bleeding or hematomas in Step patients. Step requires significantly less insertion force and puts the patient at less risk of injury than trocars. Step creates less trauma to the abdominal wall and radial dilation creates a smaller wound, thereby lowering the risk of incisional hernia. 
     

  23. Turner
    Controlled Studies Comparing Radially Expanding Access Devices with Conventional Cannulas for Laparoscopic Entry Presented at the AAGL Meeting, 1999. Published in JAAGL 6(3):S58 Overview of results of 10 controlled studies comparing sharp trocars with Step involving 1269 cases in 20 centers Abdominal wall bleeding in trocar group occurred 7.24% of the time vs. 0.31% in the Step group. 
    1 Richter's hernia and 1 bowel perforation in trocar group, none in Step group Risk of injury using trocars is approximately 10 times greater using trocars than when using Step . Compared to conventional trocars, the Step system results in less post operative pain and fewer complications.
     

  24. Turner
    Making the Case for the Radially Expanding Access System 
    Gynaecological Endoscopy 8(6):391-395, 1999 
    Narrative of personal and industry-wide evidence-based on outcome data on trocar injuries compared to safety of the Step system. Statistically significant reduction in injuries, pain and operative time using Step instead of trocars. Results of 15,000 insertions showed extremely low rate of complications Author urges surgeons to put aside personal preferences, look at the data available, and reach a consensus on how to diminish the incidence of laparoscopic complications. 
     

  25. Galen
    Clinical Outcome From Over 15,000 Cannula Placements During Laparoscopic Surgery Presented at the AAGL Meeting, 1999. 
    Review of database of over 8000 patients and 25,000 insertions (Step and control devices) Risk of complications with trocars is 2.3-4.2 times more likely to occur than with Step . Overall risk of injury using trocars 10:1 Overwhelming clinical evidence that the Step system provides far safer access than trocars.
     

  26. Turner
    The Importance of Entry Technique Presented at the ESGE Meeting, 1999. 
    Review of literature on trocar injuries, comparison to Step data. Safety and efficacy data on over 11 controlled studies involving 2878 patients. Step system provides far safer access (10x) in contrast to the conventional trocar. OR time is shorter and post-op pain is reduced. Clinical data supported FDA cleared expanded safety claims for Step, including lower prevalence of injury, lower pain, and reduced OR time.
     

  27. Donohue
    Radially Expanding Needles Safer Than Trocars 
    Ob-Gyn New 2/1/2000 Review of Galen presentation at AAGL (see abstract #25). 
    Results of a 5 year multicenter study involving 25,850 cannula insertions. Risk of complications with trocars is 2.3-4.2 times more likely to occur than with Step. Overall risk of an adverse event with a trocar is 10 times more likely to occur. Clinical evidence shows that the Step system increases safety, reduces OR time and reduces post-operative pain.
     

  28. Scarbeck
    Radially Expandable Device Cuts Bleeding 
    Ob-Gyn New 6/1/96 
    Description of the Step System and results of the retrospective study. (See abstract # 7) Mean OR time was 76 mins for Step group, 101 mins for the trocar group. Average cost savings for the Step group ranged from $345 to $515 per patient.
     

  29. Rothenberg, Georgeson, DeCou, Downey, Lelli, Raschbaum, Moores
    A Clinical Evaluation of the Use of Radially Expandable Laparoscopic Access Devices in the Pediatric Population Pediatric Endosurgery and Innovative Techniques 4(1): 7-11, 2000. Presented at the SLS/Endo Expo, 1999. Review of 2157 pediatric laparoscopic and thoracoscopic cases involving insertion of 7117 Stepд cannulas. No major vascular or visceral injuries. Three cases of abdominal/chest wall bleeding (1.4/1000), one incisional hernia in infant (0.46/1000) with 83% of defects left open. Overall incidence of injury significantly reduced compared to literature. Incidence of injury significantly lower when compared to the literature on the incidence of injury using trocars (p<0.0001). Authors conclude that the Step system is safe and effective for laparoscopic and thoracoscopic procedures in the pediatric patient, including small neonates.
     

  30. Техника введения троакараWeiner, Wagner, Blanco-Enger, Bockhorm
    Creation of Pneumoperitoneum in Obese and Super-Obese Patients by Means of Step Devices Presented at the SAGES Meeting, 2000. 
    698 obese patients (greater than 35 kg/m2) comparing 348 Hasson incisions vs. 350 Step devices placed in the left upper quadrant as the primary method of access. 15 cases of lost pneumo in Hasson group, 0 cases in Step group. Median time was 25 mins longer in Hasson group. 4 incisional hernias in Hasson group, 0 in Step group. The Step system is safe to use in obese and super-obese patients, saves time, lowers the risk of injuries, and creates a secure pneumoperitoneum with no loss of gas.
     

  31. FDA Acknowledges Safety of the Step Radially Expanding Needle Access System Scope, Society of American Gastrointestinal Endoscopic Surgeons (SAGES) 00(1): Winter, 2000 
    Discussion of the FDA clearance of enhanced Step safety claims Multiple clinical studies show that Step reduces operative complications, post-op pain, OR time, slippage, need for closure Clearance of safety claims by the FDA is rare. Clearance included statement that Step is not a cutting trocar.
     

  32. Children Reap Benefits of Radially Expanding Dilator 
    Laparoscopic Surgery Update, March: 32-33, 2000. 
    Review of a study by pediatric surgeons involving 2157 laparoscopic and thoracoscopic patients, all Step insertions. (see also abstract #29) No major vascular or visceral injuries, slippage below 1%, abdominal wall bleeding in only 0.14%, incisional hernia in 0.05%. Over 80% of the fascial defects were not closed. Compared to conventional trocars, Step significantly reduces the risk of entry-related injuries, slippage, and loss of pneumo. It is safe and effective for laparoscopic and thoracoscopic use in children.
     

  33. Galen
    Trocar Complications and Evidenced-Based Medicine Presented at the American College of Osteopathic Obstetricians and Gynecologists (ACOOG) Meeting, 2000. 
    Review and analysis of available injury data on trocar complications from the FDA and literature; comparison of 30,354 insertions of Step to 6294 control device insertions. 677 trocar injuries, 5% resulted in death, 33% were visceral, 80% associated w/safety shield, 16% associated with direct-view trocars. Mean settlement for visceral injury from trocar was $437,000. Trocars 3.3 times more likely to require closure. Injuries with trocars continue to occur. Shields and optical trocars have not prevented injury or death. Risk calculation using clinical database shows a risk ratio for abdominal wall injury of 9.7 to 1 (trocars: Step ). Evidence-based clinical outcomes support the statement that Step is safer than trocars.
     

Trocars can cause serious, sometimes fatal complications!

Standard of care: are these injuries preventable?  Yes - New Acsess Technology STEP*

Please, see MORE DETAILS on the STEP* products.


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