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      Colorectal area

      Endo-SPONGE®

      Minimally invasive method for the treatment of anastomotic leakage in the colorectal area.

      Product image of Endo-SPONGE®

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      Vacuum therapy to treat colorectal leakages complication

      After a colorectal surgery, up to 19% of the patients are diagnosed with an anastomotic leakage. [1] These leakages are associated with high morbidity and mortality. [2] There is a wide range of risk factors that must be considered. [3] The Association of Coloproctology Great Britain and Ireland states that despite the gravity of the complication and potential sequelae, data regarding risk factors and optimal perioperative management of anastomotic leakages (ALs) are relatively poor. The treatment for patients without clinical signs of peritonitis has traditionally been antibiotics and transrectal rinsing and drainage, and if sepsis is not controlled, then major surgery with debridement and permanent stoma creation. [2]

      But there is another available option for treatment when the leakage is localised in the lower pelvic area (extra peritoneal position) and there are signs of localised peritonitis of the lower abdomen. [4] It consists in vacuum-assisted closure and functions with an applied suction via open-cell foam. It's a foam sponge placed into the wound which applies a controlled pressure [5] helping removal of fluid and edema from the wound. This also increases local blood flow, reduces the bacterial load and stimulates growth of granulation tissue. [6]

      Male patient in a hospital with a male doctor laughing together

      Indication

      A solution to treat colorectal leakage – Endo-SPONGE® is indicated for patients with anastomotic insufficiencies following colorectal surgery in the lower pelvic area (extra peritoneal position) and signs of localised peritonitis of the lower abdomen.

      Decision tree

      Treatment algorithm for anastomotic leakage. [4]

      Chart of the Endo-SPONGE® indication decision tree

      How it works

      The basic principle of Endo-SPONGE® vacuum therapy consists of inserting an open-pored sponge into the leakage cavity using a flexible endoscope. A drainage tube connected to the sponge is routed through the anus and connected to a low vacuum wound drainage system. Through the application of suction, effective continuous drainage is achieved and a buildup of secretion in the cavity is avoided. The sponge in the leakage cavity induces a removal of fibrin coatings as well as shrinking and cleaning the cavity. The system is connected to the drainage bottle Redyrob® Trans Plus.

      Product picture of the Endo-SPONGE® kit

      How to use

      The sponge is introduced into the leakage cavity by flexible endoscopy. The cavity is drained thanks to the vacuum created when connecting the Endo-SPONGE® to the collecting bottle.

      Animation about Endo-SPONGE® endoluminal vacuum therapy in the colorectal area

      The treatment is performed with the patient lying on the left side. Light sedation and analgesia may be required. To begin the procedure, the application system (the overtube) is pushed into the endoscope, and the endoscope is brought up to the end of the leakage cavity. The sponge is compressed and pushed into the overtube. After the sponge has been fully unfolded, the application system is removed. The free end of the Endo-SPONGE® drainage tube is connected to the Redyrob® Trans Plus bottle. Once the sponge is in the correct position, it is checked endoscopically and the vacuum is applied.

      Real case 1

      Patient with rectal carcinoma, treated with anterior and total mesorectal resection excision and J pouch, developed a postsurgical anastomosis leakage of 20 cm depth.

      Dr. Rolf Weidenhagen, Germany

      Real case 2

      Patient male, 76 years old, a T1N0 sessile lesion excised by TransAnal endoscopic surgery. Readmitted 2 weeks later with an anastomotic leakage.

      Prof. Alberto Arezzo

      Clinical evidence

      Many years of experience treating anastomotic leakages with Endo-SPONGE® have obtained good results supported by clinical data.

      The endoluminal vacuum therapy (EVT) for rectal anastomotic leakage treatment was firstly described by Weidenhagen in 2008. Since then various retrospective and prospective cohort studies have been published using Endo-SPONGE® to treat lower Gastrointestinal (GI) defects. Up to present 40 publications have showed their outcomes and conclusions.

       

      Endo-SPONGE® treatment benefits:

      • Continuous drainage of the infected wound fluid from the cavity [5]
      • Trend to shorter treatment time compared to irrigation [7]
      • Treatment median duration is of 20-50 days [1], [5], [8]
      • Anastomotic leakage closure is achieved between 67-100 % [1], [7-12] 
      • The treatment works better the sooner it is applied after AL diagnosis [11], [13]
      • Ambulatory treatment possible [1], [5], [7], [11], [12]
      • Good patient acceptance [1], [11], [12]
      • Reduces hospital stay [1], [14]
      • Trend to reduce permanent stomas (increase stomas closure rate) [10], [14]
      • There is trend to reduce the number of re-operations [10], [15]
      • Could potentially reduce cost of AL treatments [11]

      Patient benefits

      Anastomotic leakage is particularly unpleasant for patients, since infected secretion builds up at the sphincter. This normally causes a considerable odour nuisance for themselves and also for the people around. For the patients, this represents an enormous psychological strain, the loss of their social contacts and an almost unimaginable deterioration in their quality of life. With Endo-SPONGE®, unpleasant odours disappear almost completely, the patients quality of life improves significantly, and they can once more participate in social activities practically without restriction. [4], [16], [17]

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      Ambulatory treatment 

      Endo-SPONGE® reduces the time spent in intensive care and allows an earlier discharge of patients into out-patient care, helping them to get back to normal life as soon as possible. [4], [5], [16]

       

      Good patient acceptance

      Endo-SPONGE® treatment for leakage is well tolerated by the majority of the patients with respect to pain and alteration in daily life activity. It is important to explain to them about the procedure and its maintenance at home, in order to get them prepared and increase acceptance. [4], [16], [17]

       

      Reduce the trend of re-intervention

      Endo-SPONGE® has the potential to decrease the number of re-interventions and thus reduce morbidity and mortality among patients. [6]

      Are you interested in learning more about Endo-SPONGE® endoluminal vacuum therapy?

      Endoluminal Vacuum Therapy contact form

      [1] Riss S, Stift A, Meier M, Haiden E, Grünberger T, Bergmann M. Endo-SPONGE® assisted treatment of anatomotic leakage following colorectal surgery. Colorectal Dis. 2010 Jul;12 (7 Online):e104-8. more on Pubmed

      [2] Mees ST, Palmes D, Mennigen R, Senninger N, Haier J, Bruewer M. Endo-vacuum assisted closure treatment for rectal anastomotic insufficiency. Diseases Colon Rectum. 2008 Apr;51(4):404-10. more on Pubmed

      [3] Frasson M, Flor-Lorente B, Ramos Rodrıguez JL et al., ANACO study Group.Risk factors for anastomotic leak after colon resection for cancer: ultivariate analysis and nomogram from a multicentric, prospective, national study with 3193 patients. Ann Surg 2015; 262: 321-30. more on Pubmed

      [4] Kuehn F, Janisch F, Schwandner F, Alsfasser G, Schiffnann L, Gock M, Klar E., Endoscopic Vacuum Therapy in Colorectal Surgery. J Gastrointest Surg. 2016 Feb;20(2):328-34. more on Pubmed

      [5] Weidenhagen R, Gruetzner KU, Wiecken T, Spelsberg F, Jauch KW. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: a new method. Surg Endosc. 2008 Aug;22(8):1818-25. more on Pubmed

      [6] Argenta LC, Morykwas MJ (1997), Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg 38:563-576. more on Pubmed

      [7] Nerup N, Johansen JL, Alkhefagie GA, Maina P, Jensen KH, Promising results after endoscopic vacuum treatment of anastomotic leakage following resection of rectal cancer with ileostomy. Dan Med J. 2013 Apr;60(4):A4604. more on Pubmed

      [8] Riss S, Stift A, Kienbacher C, Dauser B, Haunold I, Kriwanek S, Radlsboek W, Bergmann M. Recurrent abscess after primary successful endo-sponge treatment of anastomotic leakage following rectal surgery. World J Gastroenterol. 2010;16(36):4570-4.

      [9] Strangio G, Zullo A, Ferrara EC, Anderloni A, Carlino A, Jovani M, Ciscato C, Hassan C, Repici A. Endo-SPONGE® therapy for management of anastomotic leakages after colorectal surgery: A case series and review of the literature. Dig Liver Dis. 2015 Jun;47(6):465-9. more on Pubmed

      [10] Shalaby M, Emile S, Elfeki H, Sakr A, Wexner SD, Sileri P. Systematic review of endoluminal vacuum-assisted therapy as salvage treatment for rectal anastomotic leakage. BJS open. 2018;3(2):153-60.

      [11] Jimenez-Rodriguez RM, Araujo-Miguez A, Sobrino-Rodriguez S, Heller F, Díaz-Pavon JM, Bozada-García JM, de la Portilla F. A new perspective on vacuum-assisted closure for the treatment of anastomotic leak following low anterior resection for rectal cancer, is it worthy? Surg Innov. 2018;25(4):350-6.

      [12] Arezzo A, Verra M, Passera R, Bullano A, Rapetti L, Morino M., Long-term efficacy of endoscopic vacuum therapy for the treatment of colorectal anastomotic leaks. Dig Liver Dis. 2015 Apr;47(4):342-5. more on Pubmed

      [13] Borstlap WAA, Musters GD, Stassen LPS, van Westreenen HL, Hess D, van Dieren S, Festen S, van der Zaag, Tanis PJ, Bemelman WA. Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: the CLEAN study. Surg Endosc. 2018;32(1):315-27.

      [14] Milito G, Lisi G. Endoluminal Vacuum Therapy as treatment for anastomotic colorrectal leakage. Surg Technol Int. 2017;10(30):125-30.

      [15] Weidenhagen R, Gruetzner KU, Wiecken T, Spelsberg F, Jauch KW. Endoluminal vacuum therapy for the treatment of anastomotic leakage after anterior rectal resection. Rozhl Chir. 2008 Aug;87(8):397-402. more on Pubmed

      [16] McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winder DC. Systematic review of perioperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79.Willis S, Stumpf M. Chirurg 2004, 75:1071-78. more on Pubmed

      [17] Schintler MV. Negative pressure therapy: theory and practice. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:72-7. more on Pubmed

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