Reducing the Burden of Anastomotic Leaks

Reducing the Burden of Anastomotic Leaks

Anastomotic leaks are multi-factorial and still occur in up to 8.6% of cases.1* The consequences are enormous. Leaks reduce 5-year overall survival to as little as 33.3%.2** In addition, anastomotic leaks increase direct healthcare costs in average by approx. € 35,000 per patient, compared to treatment costs for patients without anastomotic leaks.3***

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Connected Working for Tomorrow’s Care

Ethicon strives to develop the next generation of integrated treatment solutions in colorectal care to, ultimately, give patients back their tomorrows.

We connect experienced minds and the next generation of healthcare professionals, combined with the world’s colorectal institutions and our own initiatives.

Together we can establish best practices and better standards of care. What comes next starts now.

Program Details
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Colorectal Offering

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Early Screening

Early colorectal screening is critical to achieve a high 5-years survival rate.4 Johnson & Johnson has developed a non-branded educational campaign, which can be used to raise the importance of early screening. Further, we have entered into a partnership with the patient association Digestive Cancers Europe (DiCE).

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Visualization

VISIBLE PATIENT™ can use medical imaging, including CT or MRI images to create a 3D colorectal model.4†

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Patient Centered Healthcare

We offer custom designed pathway capabilities for comprehensive disease management that guide the coordination of care, standardization of key practices and engage patients from hospital to home.

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ECHELON CIRCULAR Powered Stapler

ECHELON CIRCULAR Powered Stapler

Reduced leaks at the staple line without compromising perfusion.6§ The ECHELON CIRCULAR Powered Stapler demonstrated an 85% reduction in anastomotic leaks compared with manual circular staplers (1.7% vs. 11.8%, p=0.02).7¶

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ECHELON+ Stapler with GST Reloads

ECHELON+ Stapler with GST Reloads

The ECHELON+ Stapler with GST Reloads demonstrated better staple formation8β and 4x less slippage during firing9€ compared to Medtronic Staplers with Tri-Staple Reloads.

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HARMONIC HD 1000i Shears

HARMONIC HD 1000i Shears

More tapered jaw can enable precise access to tissue planes.10\\

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ENSEAL X1 Curved Jaw

ENSEAL X1 Curved Jaw

More efficient. ENSEAL X1 Curved Jaw can enable more efficiency through capturing more tissue per bite compared to LigaSure Maryland.11¥

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ECHELON CONTOUR Curved Cutter

ECHELON CONTOUR Curved Cutter

The new ECHELON CONTOUR™ Curved Cutter. Designed to minimize leak pathways.12$

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Procedure Manager

SPI’s platform empowers surgical teams to address variability in the OR and enhance their performance, by synchronizing workflows and accessing real-time insights.

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Colorectal Education – Professional Education​

Professional Education

Educating, coaching, development, and advocacy for those on the frontlines of health-focused on advancing the appropriate use of our products and improving patient outcomes.

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Society Collaborations

We are partnering with the European Society of Coloproctology (ESCP) whereby we are joining forces in studying the causes of anastomotic leaks and co-creating educational programs to reduce the variability in surgical technique in Europe.

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Evidence & Case Studies

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ECHELON CIRCULAR Powered Stapler

Demonstrated a 1.7% anastomotic leak rate, which was an 85% reduction compared to manual circular staplers (1.7% v. 11.8%, p=0.02) 7¶

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HARMONIC Ultrasonic Device

Reduces operative time and blood and lymphatic loss, and allows satisfactory maintenance of protein storage, resulting in a lower incidence of complications and faster patient recovery following right colon surgery.13♣

CONTOUR Curved Cutter Stapler

CONTOUR Curved Cutter Stapler

Offers higher tissue preservation and lower rates of certain complications, such as pelvic contamination, compared to conventional staplers in open and laparoscopic colorectal procedures.14

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Standardisation of Surgical Procedures

To reduce risk of anastomotic leakage, reoperation, and surgical site infection in colorectal cancer surgery: a retrospective cohort study of 1,189 patients15

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The Colorectal Next Program

Is supported by evidence, find all summaries in the Evidence Portal

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Reducing the Burden of Anastomotic Leaks

Tan Arulampalam video​ eradicating anastomotic leaks

Tan Arulampalam, UK

“This is a problem we cannot ignore any longer. This is something we have to do for our patients!”

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surgeon hands using instruments in surgical procedure

Gerrit Slooter, NL

“As a surgeon, I have to stand up for my patients and we should all reduce anastomotic leakages.”

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James Kinross video​ eradicating anastomotic leaks

James Kinross, UK

“We have to develop completely new strategies and new ways of thinking if we’re really going to meaningfully solve it.”

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Dion Morton video​ eradicating anastomotic leaks

Dion Morton, UK

“Working together to minimise and even eradicate anastomotic leak is something that, as a community, we all aspire to.”

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Helpful Links

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ESCP Congress

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Colorectal Surgery

Colorectal Speciality

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References

*Including detected abdominal fluid collection
**Compared to 67.5% survival rate of patients with no anastomotic leaks
***Study costs from Swedish hospital
†or complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full indications For Use and User Manual.
‡Finite element-based computational simulations (FEA) on simulated porcine tissue measuring tissue compression after approximation and staple formation, comparing average standard deviation of 5.481 for 2D staples to 5.109 for 3D staples (n=37, p<0.05).
§Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) manual EEA2835 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices
¶Impact of the Novel Powered Circular Stapler on Risk of Anastomotic Leakage in Colorectal Anastomosis. A Propensity Score-Matched Study. [ECHELON CIRCULAR 1.7% (1/60) vs. manual circular 11.8% (14/119), p=0.022]
♣Compared to conventional haemostasis using resorbable sutures or monopolar/bipolar diathermy
β Benchtop testing in 3.3mm and 4.0mm porcine tissue comparing malformed staples between ECHELON+ Stapler with GST Reloads (GST60B, GST60T) to Medtronic Signia™ Stapler with Tri-Staple™ Reloads (EGIA60AMT, SIG60AXT) and Endo GIA™ with Tri-Staple™ Reloads (EGIA60AMT, EGIA60AXT). Percentage malformed results: 1.14% vs 4.28%, p < 0.05
€In benchtop testing in porcine stomach tissue, the ECHELON+ Stapler with GST Reloads (PSEE60A, GST60T) had less mean longitudinal change in 4.0mm thick tissue, 0.79mm vs. 4.09mm, compared to the Signia™ Stapling System (SIGPHANDLE, SIG60AXT), p-value <0.05.
\\Device measurements based on a metrology study compared to HARMONIC™ ACE+7.
¥ENSEAL X1 Curved Jaw Tissue Sealer can capture, seal and transect a longer length of tissue per single activation due to a 16% (or 3.4mm) longer jaw (p < 0.001) and a 19% (or 3.5mm) longer cut length (p < 0.001) compared to LigaSure™ Maryland (LF1937).
$Finite element-based computational simulations (FEA) on simulated porcine tissue measuring tissue compression after approximation and staple formation, comparing average standard deviation of 5.481 for 2D staples to 5.109 for 3D staples (n=37, p<0.05).

  1. 2017 European Society of Coloproctology (ESCP) Collaborating Group. The 2017 European Society of Coloproctology (ESCP) international snapshot audit of left colon, sigmoid and rectal resections - Executive Summary. Colorectal Dis. 2018;20 Suppl 6:13-14.
  2. Marra F, Steffen T, Kalak N, et al. Anastomotic leakage as a risk factor for the long-term outcome after curative resection of colon cancer. Eur J Surg Oncol. 2009;35(10):1060-1064.
  3. Zoucas E, Lydrup ML. Hospital costs associated with surgical morbidity after elective colorectal procedures: a retrospective observational cohort study in 530 patients. Patient Saf Surg. 2014;8(1):2. Published 2014 Jan 3. doi:10.1186/1754-9493-8-2.
  4. Digestive Cancers Europe. Roadmap for colorectal cancer screening. 2018. Available online: here
  5. Visible Patient Planning, 1013, v1, User Documentation, May 2020 (157193-201027 EMEA)
  6. Ethicon, PRC077848 Leak Claims Testing, October 2016, Data on File. Ethicon, PSB004557 A comparison of staple line perfusion between 29mm ECHELON CIRCULAR™ Powered Stapler (CDH29P) and 28mm DST Series™ EEA™ Circular Stapler (EEA2835), November 2016, Data on File (114092-201126 EMEA)
  7. Pla-Martí V, Martín-Arévalo J, Moro-Valdezate D, et al. Impact of the novel powered circular stapler on risk of anastomotic leakage in colorectal anastomosis: a propensity score-matched study. Tech Coloproctol. 2021;25(3):279-284. 
  8. Ethicon, PRC096858A Evaluation of Malformed Staples in Thick Tissue for Claims: Echelon Flex Powered Plus Stapler with GST vs Endo GIA and Signia with Tri-Staple Technology, Aug 2020, Data on file (158877-201112 EMEA)
  9. Ethicon, PRC097776A Evaluation of stomach tissue movement during stapler firing for claims: Cowbell vs Signia, Nov 2020, Data on file (160327-201124 EMEA)
  10. Ethicon, PRC074607A, Buccaneer Metrology Claims, March 2016, Data on File. Ethicon, SCN075090A, Scarlet Witch Physical Equivalence memo, April 2020, Data on File (118655-210507 EMEA)
  11. Ethicon, Project Floyd: Claims Metrology Report, June 2018, PRC079564B Ethicon, Floyd Relaunch Claims Metrology, June 2020, PRC095763A (145163-200630 EMEA)
  12. Ethicon, 500561940A.7 Silhouette Tissue Compression Simulation [Claims – EU], Oct 2020 Ethicon, 500632160A Design Intent for Echelon Contour Curved Cutter, Jan 2021, Data on file (170554-210315 EMEA)
  13. Sista F, Abruzzese V, Schietroma M, et al. New Harmonic scalpel versus conventional haemostasis in right colon surgery: a prospective randomised controlled clinical trial. Dig Surg. 2013;30(4-6):355-361.
  14. Lim S, Clymer JW, Roy S. Clinical Experience with the Use of the Contour Curved Cutter Stapler in Colorectal Surgical Procedures: A Systematic Literature Review. J Surg 2018: 1130. Available online: here.
  15. Eto K, Urashima M, Kosuge M, et al.  Standardisation of surgical procedures to reduce risk of anastomotic leakage, reoperation, and surgical site infection in colorectal cancer surgery: a retrospective cohort study of 1,189 patients. Int J Colorectal Dis. 2018;33(6):755-762.

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