Name: The C-seal: A Biofragmentable Drain Protecting the Stapled Colorectal Anastomosis from Leakage (Video) | JoVE Journal
Uploaded: 2010-11-04T14:00:00.000+00:00
Duration: 7 min 51 s
Description: Learn to apply the C-seal, a biofragmentable drain that protects stapled colorectal anastomoses from leakage during surgery. This method reduces morbidity by preventing fecal extravasation.

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5 minutes

The C-seal project is a part of the collaboration between the department of surgery of the University Medical Center Groningen (UMCG) and Polyganics BV. The project was initially supported by a SenterNovem Grant of the Dutch Ministry of Economic Affairs. Intellectual property, commercial interest and patent are held by Polyganics BV. Intellectual interest is held by the UMCG. Polyganics BV has manufactured the devices for this study. The study was performed in the UMCG.

Fabrication of the C-seal
The C-Seal is made of biodegradable polyurethane, composed of hard and soft molecular components. The hard component provides the material the desirable elastic and mechanical properties. The hard component consists of polyurethane bindings (HNCO2) composed of a di-isocyanate (OCN-NCO) and a diol (HO-OH).
The soft segment determines the degradation behavior of the polyurethane. The soft segment is called the prepolymer and consists of polyether-ester chains. The hard segment is incorporated into the soft segment. This incorporation is called 'chain-extension' of the polymerization.
Once these two segments interact, a poly-ether-ester-urethane is synthesized and the polymer is ready to be processed into a C-Seal:
<ol>
<li>	The polymer is diluted to a concentration suitable for spray coating.</li>
<li>	The polyurethane solution is sprayed on a rotating mould to a certain thickness.</li>
<li>	The mould is placed into a water bath in order to release the C-seal safely from the mould without causing damage.</li>
<li>	The C-seal is dried.</li>
<li>	The C-Seal is packaged in a Tyvek pouch and sterilized using EtO gas.</li>
<li>	After sterilization, the C-Seal is ready for use.</li>
</ol>
Surgical Procedure
The patient has given informed consent for participation in the C-seal study.
<ol>
<li>	The patient is positioned in the supine position in stirrups, the abdomen and perineum is disinfected and the patient is covered with sterile drapes.</li>
<li>	Establishment of pneumoperitoneum or laparotomy via midline incision.</li>
<li>	Inspection of the liver and abdominal cavity.</li>
<li>	Mobilization of the sigmoid colon and mobilization of the splenic flexure.</li>
<li>	In open surgery: division of the sigmoid colon at the level of the proximal resection margin.</li>
<li>	Right paramedian incision of the peritoneum, opening of the presacral plane; ligation and division of the superior rectal artery and vein.</li>
<li>	Mobilization of the mesorectum.</li>
<li>	Division of the rectum distally.</li>
<li>	In a laparoscopic setting: a suprapubic incision is performed to extract the specimen. Division of the proximal sigmoid colon.</li>
<li>	The C-seal can be used if the length of the rectal stump is max. 15 centimeters.</li>
<li>	The bowel diameter determines the stapler diameter; we prefer to use a CEA stapler with a diameter of 29 or 33 mm.</li>
<li>	The C-seal and a sterilized 12mm stainless steel marble are unpacked on a clean and sterile surface using clean and sterile surgical gloves.</li>
<li>	Open the C-seal, insert the marble and insert the anvil with the connection pin first. The two flaps in the opening of the C-seal are attached to the anvil using the two strips of adhesive tape.</li>
<li>	The anvil is advanced in the C-seal so that the connection pin 'punctures' the open pointed end of the C-seal. Gently unfold the C-seal completely and make sure the marble ends up inside the C-seal away from the anvil.</li>
<li>	Any type of anastomosis (end-to-end, end-to-side, side-to-end and side-to-side) can be performed when using the C-seal; we prefer to create a side-to-end anastomosis. There are multiple strategies to insert the anvil in the proximal bowel loop. The C-seal does not interfere with any of these strategies (open bowel end with pursestring suture/longitudinal bowel incision) </li>
<li>	Insert the anvil together with the C-seal in de proximal bowel loop by first advancing the C-seal with help of the marble and, if necessary, a blunt forceps. Ensure the tail of the C-seal is placed upwards in the bowel and check that the tail of the C-seal is stretched; check the position of the marble (the marble should be at adequate distance of the anvil). Then penetrate the bowel wall with the anvil's pin and create a pursestring suture around the pin.</li>
<li>	Gently dilate the anus and insert the stapler in the rectal stump. Connect the anvil with the stapler. Check for torsion of the bowel.</li>
<li>	Fire the circular stapler. Now, the bowel ends are connected and the C-seal is attached to the staples </li>
<li>	Gently pull the stapler out of the anus. Do not turn the stapler more than 180 degrees when pulling out (the C-seal may twist). By removing the stapler from the rectum, the C-seal is pulled through the anus. Cut the C-seal at a distance of approximately 4 cm from the anus.</li>
<li> Remove the marble from the rectum. Often the marble comes out together with the C-seal. If not, gently manually remove the marble which is situated between the C-seal and the intestinal wall.</li>
<li>	Verify the anastomosis. Optionally, perform an air-test by filling the pelvis with a saline solution and inject air into the anal canal (within the C-seal and between the C-seal and bowel). The absence of bubbles confirms a complete anastomosis.</li>
<li>	If indicated, create a protective stoma.</li>
<li>	In a laparoscopic setting: exsufflation of the abdominal cavity and trocars extraction.</li>
<li>	Close the incision(s)</li>
<li>	Postoperative phase: 
Postoperative recovery is according to the ERAS (enhanced recovery after surgery) protocol9. The C-seal should be left in situ for at least one week. The patient has no restrictions and can lose stool via the C-seal. When the patient has recovered well and no anastomotic complications are suspected, the C-seal may be cut at the level of the anus. The remaining C-seal will degrade and the patient will lose the C-seal together with the stool via the natural route.</li>
</ol>
Representative Results
When the C-seal is applied correctly (figure 2 and 3), it covers the anastomosis. If a dehiscence is formed at the anastomotic site or distal from the anastomosis in the proximal rectal stump, extravasation of feces is prevented since the C-seal covers the defect and directs the fecal matter through the anus. In the postoperative phase, the C-seal protrudes from the anus (figure 3).
<img src="/files/ftp_upload/2223/2223fig1.jpg" alt="Tube geometry diagram, displaying length, inner diameter, and wall thickness dimensions." data-altupdatedat="1788235205000" data-alt="Figure 1"> 
Figure 1: Schematic drawing of the C-seal. 
<img src="/files/ftp_upload/2223/2223fig2.jpg" alt="DIY stapler assembly using marble; diagram showing step-by-step construction process." data-altupdatedat="1788235205000" data-alt="Figure 2"> 
Figure 2: Schematic representation of attaching the C-seal to the stapler head.
<img src="/files/ftp_upload/2223/2223fig3.jpg" alt="Static equilibrium; ΣF=0; diagram of tension forces in suspended systems." data-altupdatedat="1788235205000" data-alt="Figure 3"> 
Figure 3: After inserting the stapler-head together with the attached C-seal in the proximal bowel and the stapler in the rectal stump, the stapler is fired and gently pulled through the anus together with the C-seal.

<ol><li>Peeters, K. C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Risk+factors+for+anastomotic+failure+after+total+mesorectal+excision+of+rectal+cancer%5BTitle%5D)+AND+%22Br.+J.+Surg%22%5BJournal%5D)">Risk factors for anastomotic failure after total mesorectal excision of rectal cancer.</a> Br. J. Surg. 92, 211-216 (2005).</li>
<li>Dehni, N. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Influence+of+a+defunctioning+stoma+on+leakage+rates+after+low+colorectal+anastomosis+and+colonic+J+pouch-anal+anastomosis%5BTitle%5D)+AND+%22Br.+J.+Surg%22%5BJournal%5D)">Influence of a defunctioning stoma on leakage rates after low colorectal anastomosis and colonic J pouch-anal anastomosis.</a> Br. J. Surg. 85, 1114-1117 (1998).</li>
<li>Matthiessen, P. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Risk+factors+for+anastomotic+leakage+after+anterior+resection+of+the+rectum%5BTitle%5D)+AND+%22Colorectal+Dis%22%5BJournal%5D)">Risk factors for anastomotic leakage after anterior resection of the rectum.</a> Colorectal Dis. 8, 366-366 (2006).</li>
<li>Laxamana, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Long-term+results+of+anterior+resection+using+the+double-stapling+technique%5BTitle%5D)+AND+%22Dis.+Colon+Rectum%22%5BJournal%5D)">Long-term results of anterior resection using the double-stapling technique.</a> Dis. Colon Rectum. 38, 1246-1250 (1995).</li>
<li>Jung, S. H. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Risk+factors+and+oncologic+impact+of+anastomotic+leakage+after+rectal+cancer+surgery%5BTitle%5D)+AND+%22Dis.+Colon+Rectum%22%5BJournal%5D)">Risk factors and oncologic impact of anastomotic leakage after rectal cancer surgery.</a> Dis. Colon Rectum. 51, 902-908 (2008).</li>
<li>Ravo, B. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((The+intracolonic+bypass+procedure%5BTitle%5D)+AND+%22Int.+J.+Colorectal+Dis%22%5BJournal%5D)">The intracolonic bypass procedure.</a> Int. J. Colorectal Dis. 2, 38-42 (1987).</li>
<li>Ye, F., Wang, D., Xu, X., Liu, F., Lin, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Use+of+intracolonic+bypass+secured+by+a+biodegradable+anastomotic+ring+to+protect+the+low+rectal+anastomosis%5BTitle%5D)+AND+%22Dis.+Colon+Rectum%22%5BJournal%5D)">Use of intracolonic bypass secured by a biodegradable anastomotic ring to protect the low rectal anastomosis.</a> Dis. Colon Rectum. 51, 109-115 (2008).</li>
<li>Hawley, P. R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Causes+and+prevention+of+colonic+anastomotic+breakdown%5BTitle%5D)+AND+%22Dis.+Colon+Rectum%22%5BJournal%5D)">Causes and prevention of colonic anastomotic breakdown.</a> Dis. Colon Rectum. 16, 272-277 (1973).</li>
<li>Lassen, K. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Consensus+review+of+optimal+perioperative+care+in+colorectal+surgery%3A+Enhanced+Recovery+After+Surgery+%28ERAS%29+Group+recommendations%5BTitle%5D)+AND+%22Arch.+Surg%22%5BJournal%5D)">Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations.</a> Arch. Surg. 144, 961-969 (2009).</li>
<li>Kolkert, J. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Protection+of+stapled+colorectal+anastomoses+with+a+biodegradable+device%3A+the+C-seal+feasibility+study%5BTitle%5D)+AND+%22Am+J+of+Surg%22%5BJournal%5D)">Protection of stapled colorectal anastomoses with a biodegradable device: the C-seal feasibility study.</a> Am J of Surg. , Forthcoming Forthcoming.</li>
</ol>

IRB approval: Procedures involving human subjects have been approved by the Institutional Review Board (IRB) at the University Medical Center Groningen and the Dutch Central Committee of Research inv. Human Subjects (CCMO). No conflicts of interest declared.

The C-seal is a technique aimed at preventing anastomotic leakage in stapled colorectal anastomoses. It can be used in laparoscopic surgery as well as during a laparotomy. The C-seal does not prevent anastomotic dehiscence; however, it prevents leakage of feces outside the bowel lumen.
When applying the C-seal, extra care should be taken at the moment the C-seal is inserted in the proximal bowel loop. Adequate positioning of the C-seal in the proximal bowel loop is important, since it is theoretically possible to double staple the C-seal. Double stapling of the C-seal occurs when the tail of the C-seal is folded and ends up between the stapler and the stapler head. The marble helps in determining the position of the C-seal in the proximal bowel loop. The marble should be positioned at adequate distance of the stapler head, to guarantee that the C-seal tail is stretched and can not become stapled together with the anastomosis.
The C-seal can be positioned in the proximal bowel loop in different ways. If a side-to-end anastomosis is preferred, we advise to perform this according to the following protocol: The C-seal is inserted via the open bowel end, tail first followed by the stapler head. The connection pin is then penetrated through the bowel wall by stabbing it in the direction of the open bowel end. Subsequently, the open bowel end is closed and a pursestring suture is placed around the connection pin for extra support. The pin is connected to the stapler, the position of the marble is checked and the stapler is fired.
If an end-to-end anastomosis is preferred, the C-seal is inserted in the open proximal bowel end, tail first. A pursestring suture encircles the bowel end around the connection pin. The pin is connected to the stapler, the position of the marble is checked and the stapler is fired.
In a pilot study initiated by the University Medical Center Groningen, the C-seal was employed in 15 patients undergoing resection of the rectum followed by a stapled anastomoses10. No clinical or subclinical AL was diagnosed in these patients. Currently, a phase II study testing the C-seal in another 35 patients is recruiting.

<table><tbody><tr><td>Stainless Steel Marble</td><td></td><td></td><td></td></tr><tr><td>C-seal</td><td>Polyganics</td><td></td><td></td></tr></tbody></table>

the c-seal: a biofragmentable drain protecting the stapled colorectal anastomosis from leakage

The C-seal: A Biofragmentable Drain Protecting the Stapled Colorectal Anastomosis from Leakage

Colorectal anastomotic leakage (AL) is a serious complication in colorectal surgery leading to high morbidity and mortality rates1. The incidence of AL varies between 2.5 and 20% 2-5. Over the years, many strategies aimed at lowering the incidence of anastomotic leakage have been examined6, 7. 
The cause of AL is probably multifactorial. Etiological factors include insufficient arterial blood supply, tension on the anastomosis, hematoma and/or infection at the anastomotic site, and co-morbid factors of the patient as diabetes and atherosclerosis8. Furthermore, some anastomoses may be insufficient from the start due to technical failure.
Currently a new device is developed in our institute aimed at protecting the colorectal anastomosis and lowering the incidence of AL. This so called C-seal is a biofragmentable drain, which is stapled to the anastomosis with the circular stapler. It covers the luminal side of the colorectal anastomosis thereby preventing leakage.
The C-seal is a thin-walled tube-like drain, with an approximate diameter of 4 cm and an approximate length of 25 cm (figure 1). It is a tubular device composed of biodegradable polyurethane. Two flaps with adhesive tape are found at one end of the tube. These flaps are used to attach the C-seal to the anvil of the circular stapler, so that after the anastomosis is made the C-seal can be pulled through the anus. The C-seal remains in situ for at least 10 days. Thereafter it will lose strength and will degrade to be secreted from the body together with the gastrointestinal natural contents.
The C-seal does not prevent the formation of dehiscences. However, it prevents extravasation of faeces into the peritoneal cavity. This means that a gap at the anastomotic site does not lead to leakage.
Currently, a phase II study testing the C-seal in 35 patients undergoing (colo-)rectal resection with stapled anastomosis is recruiting. The C-seal can be used in both open procedures as well as laparoscopic procedures. The C-seal is only applied in stapled anastomoses within 15cm from the anal verge. In the video, application of the C-seal is shown in an open extended sigmoid resection in a patient suffering from diverticular disease with a stenotic colon.

The C-seal is a biofragmentable drain protecting the stapled colorectal anastomosis. In this video, details of the manufacturing, deployment and use are shown.

Colorectal anastomotic leakage (AL) is a serious complication in colorectal surgery leading to high morbidity and mortality rates1. The incidence of AL ...

Colorectal anastomotic leakage is a serious complication after colorectal surgery leading to high morbidity and mortality rates. In this surgical procedure, the C seal, a bio fragmental drain is stapled to the colorectal anastomosis to protect the anastomosis from leakage. First, the C seal is attached to the anvil of the Circular stapler.Next, the anvil with The attached C seal is inserted into the proximal bowel loop. The circular stapler is then fired to attach the C seal to the bowel anastomosis, and the stapler is removed from the rectum. By removing the stapler, the C seal is withdrawn from the anus.Finally, the C seal is cut four centimeters from the anal verge and the C seal is left protruding from the anus. The main advantage of using the C seal over existing methods is that the CIL protects against extra of feces outside the bowel lumen in case of colorectal anastomotic dsn. Well, the sea seal looks like the concept used in the 1980s by they invented the color shield.But the big difference between the CIL and the color shield is that the sea seal is attached together with the stapling machine and the color shield is attached in the bowel proximal to the anastomotic side. So you have to do an an extra handling to attach the color shield inside the bowel, and that takes a lot of time, extra surgical time, and the CSO is attached together with a surgical stapler to the anastomotic site, and thereby no extra delays introduced in the surgical procedure, Dilute the polymer to a suitable concentration for spray coating and spray the polyurethane solution On a rotating mold to a certain thickness, the concentration of the spray solution is 4%The wall thickness of the C seal is 70 micrometers after 30 minutes, release the C seal by placing the mold in a room. Temperature water bath once released, the C seal is dried by freeze drying in a minus 18 degrees Celsius freezer for two hours.The C seal is packaged in a Tyvek pouch and sterilized using ethylene oxide gas prior to use. The C seal can be stored for 12 months at or below Four degrees Celsius. The C seal can be applied in anastomosis within 15 centimeters, distance from the anal verge.Often this is a low interior resection. The patient in the video is suffering from diverticular disease and has a stenotic colon. Therefore, a more extensive resection of the sigmoid colon was necessary.This protocol starts at the moment that the well vascularized afferent bowel loop can be tension-free anastos with the rectum stump, Using A fresh pair of sterile surgical gloves. Unpack the pre sterilized C seal and a sterilized 12 millimeter stainless steel marble onto a clean, sterile surface. Next, open the C seal.Insert the marble, and then insert the anvil with the connecting pin. First, using two strips of adhesive tape, attach the C seal to the anvil firmly. Press the adhesive strips Of the C seal onto the stapler head.Advance the Anvil into the C seal so that the connection pin punctures the open pointed end of the C seal. Then gently unfold the C seal completely and make sure that the marble ends up inside the C seal away from the anvil. If you do not completely unfold the C seal, it can become double stapled and can get stuck at the anastomotic site.Insert the anvil together with the C seal in the proximal bowel loop by first advancing the tail of the CIL with the help of the marble. If needed, use blunt forceps to facilitate this. Ensure the tail of the C seal is placed upwards in the bowel, and make sure the tail of the C seal is stretched.The tail orientation is important because you do not want the tail to be stapled together with the anastomosis. When creating a side to end anastomosis, penetrate the bow wall with the anvil's pin staple off the stenotic colon. Check the position of the marble, which should be at least six centimeters away from the anvil.We advise to create a purse string suture around the pin for extra support, gently dilate the anus and Insert the stapler in the rectum. Connect the anvil with the stapler. Fire the circular stapler.At this point, the bowel is reconnected and the C seal is attached to the staples. Gently pull out the stapler through the anus. After opening the stapler, according to the corresponding protocol, the stapler should not be turned more than 180 degrees when pulling out the stapler.Otherwise, the C seal may twist as the stapler is removed from the anus. The C seal is pulled through the anus, cut the C seal approximately four centimeters from the anus. When the C seal is applied correctly, it covers the anastomosis.Remove the marble from the rectum. Often the marble comes out together with the C seal. If not gently, manually remove the marble, which is situated between the C seal and the intestinal wall.Optionally, an air test is done to verify the anastomosis. This is done by filling the pelvis with saline solution and simultaneously injecting air into the anal canal within the C seal, and between the C seal and the bowel. Absence of bubbles confirms a complete anastomosis.If a nce forms at the anastomotic site or below the anastomotic site, the cyl covers that gap. So in case of that de essence, the feces is not able to flow outside the bowel lumen. Since the C seal covers the defect and the C seal directs actually the fecal stream outside the bowel lumen through the anus, the C seal can cause some hygienic discomfort due to soiling as long as the sea seal crosses the anal swinger, and therefore, we advise to rinse the sea with water after the ation.When the sea seal is applied correctly on the Anil, it should look like this. Ensure the tail of the sea seal is stretched before firing the stapler. Therefore, check the position of the marble, which should be at least six centimeters away from the anvil.When pulling the stapler out of the anus, the C seal comes out together with the stapler. After cutting the C seal at approximately four centimeters from the anal verge, the C seal is left protruding from the anus. When the patient is recovered and no anastomotic complications are suspected, the CCL can be cut off at the level of the anus.The remainder of the CCL will degrade over time and the patient will expel it with normal stool production. After watching this video, you should have a good understanding of the rationale and the application of the CIL and patient's undergoing colorectal resection with the creation of a colorectal anastomosis.

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Learn to apply the C-seal, a biofragmentable drain that protects stapled colorectal anastomoses from leakage during surgery. This method reduces morbidity by preventing fecal extravasation.

The C-seal: A Biofragmentable Drain Protecting the Stapled Colorectal Anastomosis from Leakage

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