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CR Terms, Anatomy and Procedures
- 1. Agenda Review strategicgoals and tasks Terms, Anatomy, Procedures, Staplers and Diseases Review COST, MITT & Cima studies Q & A
- 2. Why We’re HereMission: double the HALS market (40mm > 80mm) in 3 years while maintaining at least 80% market share. Strategic Goal ≈ 64mm in GP revenue by 3Q2011 Challenge: Converted most of Lap Disc & Dextrous business Ethicon Endosurgery isn’t going to develop HALS market like they did in the past due to poor ROI, we have to do it. Strategy: Convert “pure” lap and open surgeon to HALS for their complex (left, sigmoid & LARs) CR procedures. Tactics: Develop a national sales force comprised of subject matter experts on HALS for complex CR procedures Provide leadership, tools and motivation to convert 5 surgeons per territory per year
- 3. Turning Strategy intoTactics (how we’re gonna do it) ID surgical problem Applied + HALS solves Lap surgeon Conversion rate OR time Mobilizing splenic flexure Mobilizing sigmoid Accept more pts in, refer fewer pts out Open surgeon Accept more pts in, refer fewer pts out Climbing the learning curve Mastering medial-to-lateral mobilization Same problems Lap surgeon has while converting to HALS
- 4. Turning Strategy intoTactics (how we’re gonna do it, cont.) Become subject matter expert on solving those problems Focus on 2 diseases Adenocarcinoma diverticulitis Focus on 3 procedures left hemicolectomy sigmoidectomy low anterior resection Focus on mobilization step splenic flexure descending colon sigmoid colon
- 5. Direction and OrientationLateral Medial Distal Proximal Caudal Cephalad Left Right
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- 7. Extra, Intra &Retro Structures Extraperitoneal Anus Distal portion of rectum Intra Proximal 1/5 th of duodenum Jejunum Ileum Gallbladder Liver Spleen Stomach Rectum (mostly) Sigmoid colon Transverse colon Retro (HALS) Abdominal aorta Appendix Ascending colon Bladder Descending colon Distal 4/5 th of duodenum Hepatic flexure Pancreas Sigmoid flexure Splenic flexure Ureters
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- 21. HALS Value PropositionMobilize the splenic flexure to gain enough bowel for left hemicolectomies, sigmoidectomies and LARs. Mobilize structures adhered due to advanced diverticulitis and cancer
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- 23. Adenocarcinoma = Malignantgrowth of glandular tissue The colon is lined with smooth glands that secrete fluids to aid in forming stool. Polyps can form from these glands and can be precursors to cancer. All colon cancers grow from the inside out. Staging is based in part on how far the cancer has spread from it’s initial location. Once the cancer has perforated the exterior bowel wall the body will attempt to isolate the insult by encapsulating it in fibrous tissue. It is this same immuno-response, the walling off of the cancer, that we know as adhesions. An basic principal of oncological surgery is to minimize the handling of diseased tissue. It is very difficult to both mobilize diseased and adhered tissue, and at the same time minimize manipulation. HALS allows the surgeon to feel the disease, gently and precisely handle the tissue and potentially minimize tissue trauma. It also allows for more precise and atraumatic mobilization.
- 24. Review Procedures Lefthemicolectomy Sigmoidectomy Low Anterior Resection (LAR)
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- 26. Did we coverall the terms – review the list What questions do you have?
- 27. COST, MITT &Cima COST = Lap ok for cancer MITT = HALS is better than Lap Cima = HALS is better than Lap
- 28. COST & MITTHALS is slower than open & faster than lap HALS incision is smaller than open and comparable to LAP No difference in hospital stay between any of the three approaches 5.2 days 6 days Lap 5.7 days not reported HAL not reported 6 days Open Hospital Stay (median) 6.1 cm 6 cm Lap assisted 8.2 cm not reported HAL not reported 18 cm Open Incision Size (median) 208 mins 150 mins Lap assisted colectomy 175 mins not reported HAL colectomy not reported 95 mins Open colectomy OR Times (median) MITT Study COST Study
- 29. Comparison of LaparoscopicallyAssisted and Open Colectomy for Cancer (COST) 2004 NEJM Why? July 1994 Lancet presented a study reporting a 21% port site recurrence rate during lap colectomy. (3-14) Effectively ended lap colon work. COST Study Open Lap No statistical difference incisional site seeding <.01 <.01 No statistical difference in recurrence rates .18 .16 No statistical difference in 3 yr survival rate .85 .86 No statistical difference in time to recurrence from baseline stage Length of stay was shorter for lap than open 6 days 5 days Duration of pain management was shorter for lap parenteral narcotics 4 days 3 days oral analgesics 2 days 1 day The rates of intraoperative complications, 30-day postoperative mortality, complications at discharge and 60 days, hospital readmission, and reoperation were very similar between groups. “ Conclusions In this multi-institutional study, the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy, suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer. “ Result: Lifted the moratorium on lap colon for cancer Design; prospective, randomized, multi-center. 872 randomized, 863 operations, 90 conversions
- 30. Comparison of LaparoscopicallyAssisted and Open Colectomy for Cancer (COST) 2004 NEJM Initiated & began accepting pts in 1994, same year as Lancet article. Completed all procedures by August 2001. Published May 2004, 10 years after 21% port site recurrence rate was reported. Open or “pure” lap with exteriorization for anastomosis, only. HALS was not used. Median incision sizes were different; open = 18cm, lap = 6cm. Is there a clinical significance between a 6 cm (lap) incision and an 8 cm (HALS) incision? 90 patients were converted to open = 21% conversion rate. Experienced surgeons who passed screening (videos required) converted 1:5. How does that compare to our “pure lap” surgeons?
- 31. Hand Access vs.“Pure” Laparoscopic Colectomy: A Multicenter, Prospective, Randomized Trial Diseases of the Colon & Rectum (2008) Referred to as the “MITT” study. M inimally I nvasive T herapeutic T rial (MITT) Group Why? Resolve debate within C\R community. Address criticism of previous studies. Incorporate improved hand access technology – GP. Stated purpose: “…compare short-term outcomes after hand-assisted laparoscopic vs. straight laparoscopic colorectal surgery” Primary end-point: OR time HA LAP sigmoid & left colectomy = skin-to-skin 163 mins 208 mins (total colectomy = skin-to-colectomy 127 mins 184 mins(+57) Secondary end-points: HALS colectomy resulted in fewer conversion 2%(1) vs 12.5%(6) Average extraction incision was smaller in lap (6.1cm) than HA (8.2cm). HALS colectomy maintained the same clinical outcomes as straight laparoscopy; LOS, return of bowel function, post-op pain and analgesic usage & post-op complications
- 32. Experience with 969Minimal Access Colectomies: The Role of Hand-Assisted Laparoscopy in Expanding Minimally Invasive Surgery for Complex Colectomies (aka “Cima” study) Cima Study. Dr. Robert Cima PI. C\R surgeon @ Mayo. Presented Dec 2007. Published 2008. Small percentage of all colectomies in US done MIS; 3-5%. Large # of pts missing benefits of laparoscopy. Lap C\R work is technically difficult. Steep learning curve requiring more cases that most GS & C\R surgeons perform in a year. “ HALS effectively bridges the complexity divide between minimal access and open procedures.” Substantial growth in HALS with no drop in LAP during the study period. (see chart) Similar post-op findings as in MITT study. Shorter OR times w\equal post-op results. Criticism Mayo has superb surgical assistants compared to community based facilities Response = Applied HALS training course can mitigate the issue Higher leak rate; HALS = 6 of 316 (<1%), LAC = 0 of 241 Response = All anastomoses were performed extra-corporeally Higher wound infection rate; HALS = 14 of 316 (4%), LAC =5 of 241(2%) Response = higher % of riskier patients in HALS group (IBD & totals)
- 33. Growth of complex(left, sig, LAR, subtotal & total w\wo IPAA) MIS colon cases during CIMA study
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Editor's Notes
- #7 The red line is the peritoneum and mesentery. The peritoneum and mesentery are both made of a single sheet of thin, semi-transparent tissue. This “cellophane” lines the entire abdominal cavity and all viscera. In embryo all organs were grown from an area “behind” the peritoneum...a space between the peritoneum and the abdominal wall. Some organs, like the small intestine, needed additional room in which to develop. Since the small intestine eventually grows to over 20’ in length, there isn’t enough room on the surface of abdominal wall to grow, so it and other organs grow into the abdominal cavity. Along the way they pull the peritoneum, which grows as the organ grows. Within this growing peritoneum are all the vessels and nerves needed to support the organ. Eventually the peritoneum extends inward so far that it folds back on itself and forms a thicker tissue - which we refer to as mesentery. Some of the organs never develop a mesentery as they don’t need additional room to grow. They stay in close proximity to the abdominal wall “behind” the peritoneum. We refer to these organs as retroperitoneal. The organs that did need to grow and moved away from the abdominal wall (and therefore have a mesentery) are called intraperitoneal. Since retroperitoneal organs don’t have a mesentery, and they are “stuck” against the abdominal wall behind the peritoneum, they tend to be more difficult to mobilize. Therefore, HALS is an excellent tool to use when surgeons are mobilizing retroperitoneal organs.
- #9 This is the primary slide we use to teach C\\R terms and anatomy. Included in the training packet is an excel file that cross-references each number with a definition. The numbering has changed since we met in Chicago because Haustra was listed twice and the rectosigmoid junction (19) wasn’t listed at all. It is important for us to model mastery of these terms if we expect TMs to be confident in their own knowledge so please take some time to review them before the presentation. In order to get audience involvement consider having them read off the definitions sequentially 1-20. Ensure adequate understanding of all terms with special focus on the difficulty in mobilizing the splenic flexure (14) and the sigmoid colon (17) when treating advanced diverticulitis and carcinoma. Both diseases are highly localized to the sigmoid colon and the rectum, making mobilization of those structures difficult. In the vast majority of left hemicolectomies, sigmoidectomies and LARs the splenic flexure must be mobilized in order to gain adequate bowel length for a tension-free anastomosis. This can be challenging due to its remote location from port sites, its retroperitoneal nature and its proximity to significant organs like the spleen, tip of the pancreas and kidney. Hand assisted mobilization of the SF is a critical benefit to surgeons and must be a key feature of selling to surgeons.
- #10 Apologize for the distorted image…please feel free to fix it if you can. This image represents the arterial supply to the colon with the transverse colon retracted cephalad. Since we are focusing on procedures involving the left side, sigmoid and rectum, please focus on those arcades. The inferior mesenteric artery is the primary conduit for structure involved in these procedures. When surgeons perform a wide area margin technique they will harvest the IMA in relative proximity to the abdominal aorta. In a medial-to-lateral approach, which our proctors favor for HALS, ligating the IMA is first “real” part of the procedure after they’ve gained access, inspected the viscera of the cavity and swept the greater omentum and small bowel aside. An otomy (opening) is created in the mesocolon near the assumed location of the IMA. The surgeon will use blunt dissection and finger dexterity to demonstrate the IMA and AA. Once an adequate visualization has been made and the IMA is confirmed, the surgeon will use either energy or clips to ligate. While not a technically challenging step, the proximity of the IMA to the AA demands special care. HALS affords the surgeon the opportunity to palpate the IMA and AA for perfect knowledge of the anatomy and to quickly gain hemostasis in case of an “unplanned development”.
- #11 Another look at the arterial supply to the colon. This image, with the transverse colon again retracted cephalad and the sigmoid flexure retracted laterally, demonstrates how the arteries are actually encapsulated within the mesocolon. It also shows the path of the right ureter coursing over the bifurcation of the common-to-internal ileac. It is easy to envision the left ureter following a mirrored course on the opposite side, but deep to the sigmoid flexure and s. colon. It is the left ureter that is in jeopardy during mobilization of this structures. Subsequent slides will clearly show the left ureter, but you may want to introduce the issue early and often.
- #12 This plate is shown to demonstrate that veins parallel arteries. The left ureter is also more visible in this image than in the previous one.
- #13 The focus is on the upper left image and the lymphatic system of the colon. Lymph nodes serve as a collection and isolation point for lymph fluid as it moves from interstitial space to the subclavian veins, where it enters the circulatory system for disposal. Our interest in the lymphatic system of the colon in based on its function as a transporter of living cancer cells. These cells can be collected in lymph nodes which are referred to as “sentinel” nodes. Current oncologic principles mandate the harvesting of at least 12 of these nodes in order to perform an effective screening\\staging of cancer. This requirement drives the need to do a wide area margin (aka “wedge”) surgery in which all tissue incorporated into an area best described as a triangle is harvested. See the next slide for visual evidence.
- #14 These diagrams represent a wide area margin or wedge technique used to treat cancer. The goal is to harvest the diseased tissue and all associated tissues, including the mesocolon. The arteries, veins, nerves and lymphatics of the diseased colon tissue are all incorporated into the mesocolon. This technique also increases the likelihood that surgery on the left side will require mobilization of the splenic flexure, as enough bowel has to be “pulled down” to form a tension-free anastomosis. Many of our proctors always perform a “cancer” surgery regardless of the disease they are treating. By consistently performing the same procedure they increase their skills and the skills of others in the OR supporting the case. Notice that in some of the images branches of the IMA are harvested (lower left, lower middle) while in the lower right image the IMA is harvested. The IMA can be harvested without compromising the rectum or splenic flexure.
- #15 The upper left drawing demonstrates the divergence of the tenia coli which begins near the sigmoid flexure and is complete at the proximal rectum. In fact, absence of tenia is a distinguishing characteristic of the rectum. It is also easy to appreciate that the rectum is essentially a muscular storage facility for fecal matter awaiting evacuation.
- #16 This is an excellent drawing to explain a number of key anatomical features as they relate to HALS. First, the rectum is longer than many people believe. According to the artist the rectum is approximately 15-17 cm (6”-7”). The HALS surgeon has the ability to directly manipulate the rectum to facilitate mobilization and control the EEA during the anastomosis, while the laparoscopist must rely on insensate instruments. Second, about half of that length is difficult to access through the abdominal cavity as it lays inferior (infra- or extra- peritoneal) to the peritoneal reflection. The term “deep in the pelvis” refers to the most distal portion of the rectum accessible to that surgeon. Third, it is important to understand that all surgeons are not created equal and that surgical skills can be a limiting factor in how low a low anterior resection can be. Finally, this drawing also shows the surgical anus as 4-5 cm (1.5”-2.0”). Its boundaries are (proximal) the anorectal line and (distal) the anal verge (hair bearing to non-hair bearing skin).
- #17 A great view of key structures low in the pelvis and the extraperitoneal anatomy. First, focus on the location of the left ureter in comparison to the sigmoid colon. Though the ureter is retroperitoneal, it can be accidentally ligated during mobilization of the sigmoid. The HALS surgeon has the benefit of tactile feedback to assist in safe and complete mobilization. Second, the rectum is shown as passing into and deeper pocket before exiting the peritoneal space. This lower, depressed area is the pararectal fossa. The Contour 45 from EES is designed to fit into this space and assist with deep transection of the rectum. Finally, reviewing the peritoneum may be appropriate at this time since we can clearly see how it covers retroperitoneal structures.
- #18 The purpose of this slide is to offer a different perspective on the lower pelvis organs in the male and how they relate to each other. The median sagittal view is probably the more helpful. The rectovesical pouch (brown pocket in drawing) is the anterior portion of the pararectal fossa discussed on the previous slide.
- #19 The purpose of this slide is to offer a different perspective on the lower pelvis organs in the female and how they relate to each other. The median sagittal view (top drawing) is probably the more helpful. The rectouterine pouch (aka pouch of Douglas) is the anterior portion of the pararectal fossa discussed on the earlier slide. We can see how easily a rectovaginal fistula could develop from a perforation of the anterior rectum.
- #20 One of the more important images as this is the view we often see during lap C\\R surgery. This is a superior view of a male cross-section cephalad to the sigmoid colon. Again, we can observe the close proximity of the left ureter to the sigmoid, the left gutter, the peritoneum and the pararectal fossa. All key anatomical concerns for us.
- #21 One of the more important images as this is the view we often see during lap C\\R surgery. This is a superior view of a female cross-section cephalad to the sigmoid colon. Again, we can observe the close proximity of the left ureter to the sigmoid, the left gutter, the peritoneum and the pararectal fossa. The ovaries and potential crowding of the low pelvis are also observed. All key anatomical concerns for us.
- #23 This image illustrates different aspects of diverticulitis on a cross-section of colon. Diverticula are simply out-pocketings of the lumen of the bowel. Typically they occur at the weakest point of the wall – the point of entry\\exit for blood vessels. The diverticulum themselves are frequently asymptomatic and can go untreated. Eventually they may become infected and require either medical or surgical treatment. When medicine fails surgical resection is required. As the diverticulitis develops the body tries to seal off the infection by surrounding the segment with tissue. It is this response that results in adhesions that make mobilization more difficult. An excellent opening question for “pure” lap surgeons is “What are the most common reasons for converting to open in an advanced diverticulitis case?” Typically the answer will involve challenges in mobilizing the diseased segment and\\or challenges in sufficiently mobilizing the splenic flexure to ensure a tension-free anastomosis. Since diverticulitis predominately occurs in the sigmoid colon and rectum, HALS is a perfect tool to assist in mobilization.
- #26 This presentation is in a word file named “stapling overview”
- #34 This slide demonstrates that we can grow the market by converting open and lap surgeons to HALS. In 2003 there were <80 complex (see title for definition) lap assisted colon (LAC) cases performed at the Mayo Clinic. In Nov-Dec 2003 there were less <20 LACs performed and less than 10 similar HALS case. In 2004 >80 LACs were performed and nearly 80 HALS complex colons were done. The LAC number fell to 60 in 2005 as some surgeons probably became more selective in which cases they did LAC and which were done HALS. However, the HALS cases continued to climb in 2005 with about 110 being performed. Remember, in 2003 HALS barely made the chart in two months. This growth in HALS continued in 2006 reaching nearly 140 cases. LAC also grew but was well behind HALS. The take away is that it is possible to grow the size of the pie (market size) while maintaining our leadership position.