Contents 1. Anastomotic leak – basic problem of colon cancer treatment. 2. Miasmas of large intestine. 3. Palpatory intestinal trauma. 4. Base of Adequate method of single-moment large intestine resection. 5. Possibilities of Intestinal intubator with drain and irrigator (IIDI). 6. IIDI. Securing of atraumatic intubation. 7. IIDI. Managing of intubation. 8. IIDI. Antegrade desinfecting system "Flow". 9. IIDI. Emptying system "Drain with Irrigator" (DI). 10. IIDI. Algorithm of operational application. 11. Clinical estimation of the Method. 12. Conclusion. 13. Sources of information. © Reference on is obligatorywww.coloncancer.lv S.A. Matasov Adequate method of single-moment large intestine resection - Aseptics? - Ignored horror of coloproctology! From the conversation in operation room

1. Anastomotic leak – basic problem of colon cancer treatment S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 1 Mortality rate at operative CRC treatment is very high and varies widely. According to German data of 2013, during 30 days after primary anastomosis died 12% of patients, after Hartmann operation - 25% [1]; in the article from UK the last figure is higher - 30% [2]. Mortality rate in most cases: 6-39% [3], 6-22% [4], 25% [5] is associated with anastomotic leakage.[1] [2][3][4][5] Inflammation-suppuration of operational wound by frequency is close to anastomotic leakage, the last years figures are as follows: 13,7% [11], 12.5% [12], 23.5% [13].[11][12][13] Anastomotic leakage takes place in average in 11%; this figure is increasing the closer anastomosis approaches to the anal verge, after rectal resections could reach even 50% [6]. Here are other figures: 10-20% [7], 15% [8], 2,5-20% [9], 10-19% [10]. [6][7] [8][9][10]

Nearness of the rates of anastomotic leakage and inflammation-suppuration of operational wound are explained by their common reasons: infection and traumacity of tissues. That is, leakage an suppuration are the result of non- compliance of basic requirements of general surgery: 2. Miasmas of large intestine. Aseptics and antiseptics are more than 150 years old, however there are no technologies that could ensure large intestine’s disinfection; systems like Coloclean [14], [11] and Retrowash [15] could not ensure even quality lavage. This is confirmed by opacity and yellow colour of final portions of lavage liquid. Inevitability of infections of intestinal sections and anastomosis sutures could be seen from data of colonoscopes reprocessing [16]:[14][11][15][16] 1. After colonoscopy contamination approaches to 9 units (lg CFU/ml). 2. Colonoscope’s washing by water reduces contamination by 20%. 3. High-level desinfection (HLD) approaches contamination to 0. Ensuring of compliance of these requirements minimizes anastomotic leakage risk! The risk of inflammation and suppuration of anastomosis is explained not only by the lack of aseptics - measures that reduce the amount of microbes in large bowel after operation and risk of their penetration into anastomosis. S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 2 aseptics and antiseptics, atraumatic manipulations. Aseptics is a method of surgery, providing the prevention of getting of microbes in operational wound [17] Antiseptics is a system of measures aimed on decreasing amount of microbes in the wound, reduction of risk of their penetration in the wound and their development therein [17]

3. Palpatory intestinal trauma Intubational trauma: stratification of mucosal and muscular layers Intubational trauma: hematoma of muscular layer Surgeons are well acquanted with sensitivity of intestinal wall; experiments showed the status of its structures after palpatory intubation [20]. Intubational trauma and the neuro- reflex response on it, resulting in vascular spasm, ischemia, necrosis – is the second cause of inflammation, suppuration and unhermetization of anastomosis. Colon lavage, decompression, emptying [18] are realised by its milking and palpatory intubation. Refusal from these on-table manipulations in favour of unloading ostomy is usually proved by their traumacity, corking of tubular drains, threat of contact bedsores [19].[18][19] S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 3

4. Base of Adequatemethod of single-moment large intestine resection The novation is devoted to memory of my grandfather, Sarkis Abramyanc from Van, who died after surgery on sigmoid colon Solution of anastomosis leak problem requires technologies which ensure compliance of aseptic and antiseptic methods of surgical work, exclude intestinal injury. The technical mean for realization of the Method become the complex Intestinal intubator with drain and irrigator (further -IIDI) [21]. S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv Realization of the Method proposed begins during operation and continues after it. The operation includes 2 transanal large intestine intubations: the 1 st provides disinfection of intestine before making of anastomosis, the 2 nd - disinfection and decompression of anastomosis in post-operational period, as well as roentgenological control of its hermecity. 4

During operation: 1. Intubation inquiry of intestine Absent 2. The length of transanal intubation Up to 160 cm 3. Intubation is controled by Operating surgeon 4. Temp of intubation Step by step 5. Intubation in case of intestinal obstruction Provided 6. Direction of disinfectant's flow Antegrade 7. Speed and pressure of disinfectant Up to 10 l/min; cm H2O 8. Emptying of intestine after disinfection Provided 9. Pressure for emptying of intestine Minimal After operation: 10. Desinfection and emptying of intestine Provided 11. Evacuation of contents, coming from small intestineProvided 12. Roentgenological control of anastomosis’ hermecityProvided 5. Possibilities of Intestinal intubator with drain and irrigator (IIDI) S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 5

Large intestine Intubation is realised by 2 forces acting according the "push-and-pull" principle. The force "pull" is created by invaginator evertable like a finger of surgical glove; together with drain enclosed therein, it is rolled on mucosa. The source of "push" force is feeder; during the intubation process it pushes invaginator with drain and then intractor into the everted inflated part of invaginator. 6. IIDI. Securing of atraumatic intubation. S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 6

Intestinal intubation (see video) is carried out by surgeon by periodic pressing the feeder pedal; by hand he controls the direction of invaginator's evertion. Step of intubation – 5-10 cm, total duration - about 1 minute. 7. IIDI. Managing of intubation To watch the video click on photo S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 7

System is completed by everted invaginator opened at the final point of intubation (see on slide 6). Its diameter - 18 mm - provides a flow of disinfectant with speed up to 10 l/min. After filling, for example, caecum and ascending intestine, liquid starts an antegrade movement along colon, carrying contents with it. Disinfection require dozens of liquid liters, its level over the intestine should be about 5-10 cm. 8. IIDI. Antegrade disinfection system "Flow" S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 8

DI system comprises irrigator in the shape of slleve with punctures, enclosed in the spiral- mesh drain [22]. Feedinng of disinfectant into irrigator squeezes content of drain, washes the mesh, irrigates intestines with the speed of 2 l/min; feeding of roentgenocontrast ensures check of hermecity of anastomosis. DI system guarantees 100% emptying of intestine before making of anastomosis and after operation, evacuation pressure at that should be about 30 cm H2O. For removal of chimus, which comes after operation into the final point of intubation from the small intestine, the tube Intractor is used (see on slide 6, right). 9. IIDI. Emptying system "Drain with Irrigator" (DI) S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 9

10. IIDI. Algorithm of operational application. Variants of 1-moment operation [23] at obturation and without it should include following actions: The sleeve also suppose also estimation and grinding of intestinal content. Transparent elastic sleeve connects Truncated sections during disinfection 1. Resection of tumour. 2. Temporary connection of truncated intestines by elastic sleeve. 3. Intubation, disinfection, emptying of truncated intestines. 4. Extubation, removal of sleeve, making of anastomosis, final intubation. S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 10

By the request of prof. E.A.Babayan, chairman of the Committee on New Technologies of the USSR Ministry of Health, the Department of Hospital Surgery of 2nd MMI realized the clinical estimation of the Method. On February 23, 1983, A.A.Grinberg has given the following report: "This method has given a good clinical effect and could be recommended for the treatment of patients suffering from acute intestinal obstruction, peritonitis, to protect anastomosis during operations on colon tumors". Method was approved and supported also by RAMS prof. V.D.Fedorov Clinical estimation of the Method USSR Author certificates, Countries of patenting, S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 11

Partnership Interpetation of I.Surovtsev sketch Anastomotic leak is the result not only of the pathological processes in large intestine prior to surgery, but also of the non-compliance of aseptics at making of anastomosis and antiseptics during its maintenance, as well as of the palpatory trauma. 12. Conclusion Intestinal intubator with drain and irrigator ensure atraumatic intubation and disinfection of intestine before making of anastomosis and after operation. Taking into account complications and high mortality after surgical treatment of CRC, the project requires state and international support. Aim of this report - search of partners for wide clinical trials of the Method S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv 1212

13. Sources of information S.A. Matasov. Adequate method of single-moment resection of large intestine © Reference on is obligatorywww.coloncancer.lv Primary anastomosis with a defunctioning stoma versus Hartmann’s procedure for perforated diverticulitis – a comparison of stoma reversal rates. Alizai PH et al., International Journal of Colorectal Diseases, Dr._Foster’s_report_with_CR_POSSUMDr._Foster’s_report_with_CR_POSSUM Mortality following Hartmann’s procedure – correlation of Dr. Foster’s report with CR-POSUM. Neeraj Lal et al., Research Gate, United Kingdom, June Reducing Anastomotic Leakage in Oncologic Colorectal Surgery: An Evidence-Based Review. Mark A. et al., Anticancer Research, February Anastomotic Leak After Low Anterior Resection. Hannah Caulfield et al., JAMA Surgery, Management and outcome of anastomotic leakage after colonic surgery. A. Rickert et al., Colorectal Disease. Vol.12, Issue 10, October Do we really know why colorectal anastomoses leak? Benjamin D.Shogan et al., Journal of Gastrointestinal Surgery, May Complications in Colorectal Surgery. David W. Dietz, MD, American Society of Colon and Rectal Surgeons, Anastomotic leak after low anterior resection: a spectrum of clinical entities. Caulfield H, Hyman NH. JAMA Surgery, February doi/10.11codi.12167/full Late anastomotic leakage in colorectal surgery: a significant problem. A.N. Morks et al., Colorectal Disease, Vol.12, Issue 5, April doi/10.11codi.12167/full 10. Promising results after endoscopic vacuum treatment of anastomotic leakage following resection of rectal cancer with ileostomy. N. Nerup et al., Danish Medical Journal, 60(4), Хирургическое лечение кишечной непроходимости у больных обтурирующим раком левых отделов толстой кишки, Д.Е.Попов и др., Вестник Санкт-Петербургского Университета, Сер. 11, Вып.2, Risk factors associated with surgical site infection after ileal pouch-anal anastomosis in ulcerative colitis. Tomita N. et al., Diseases of Colon and Rectum, 53(2), February Association between incisional surgical site infection and the type of skin closure after stoma closure. Kobayashi S. et al., Surgery Today, 41(7), July 2011www.ncbi.nlm.nih.gov/pubmed/ Cелькoва Е.П. Гренкова Т.А., Проблемы инфекционной безопасности в гибкой эндоскопии, Стручков В.И. Общая хирургия, «Медицина», Москва, Декомпрессия межкишечного анастомоза в профилактике его недостаточности. «Осложнённый рак толстой кишки». Г.А. Ефимов, Ю.М. Ушаков Противопоказания к интубации кишечника. Ретроградная интубация кишечника Матасов С.А., Ильинский И.М. Морфологические изменения кишечника при его интубации в эксперименте. Хирургия, 1982,10, с Матасов С.А. Одноразовый интубатор колон с дренажом и ирригатором, Евразийский патент № , Европейский патент № ЕР , Матасов С.А., Кишечный дренаж, авторское свидетельство СССР № , Бюллетень Матасов С.А. Асептический способ одномоментной резекции опухоли толстой кишки и устройство для его осуществления. Патентная заявка ЛР Р-12-66, Матасов С.А. Проблемы и перспективы интубации кишечника, www.coloncancer.lv/kniga_engl.pps