- Email: [email protected]
Protection of stapled colorectal anastomoses with a biodegradable device: the C-Seal feasibility study
The American Journal of Surgery (2011) 201, 754 –758
Clinical Science
Protection of stapled colorectal anastomoses with a biodegradable device: the C-Seal feasibility study Joe L. Kolkert, M.D.a, Klaas Havenga, M.D., Ph.D.a, Henk O. ten Cate Hoedemaker, M.D.a, Johan Zuidema, B.Sc.b, Rutger J. Ploeg, M.D., Ph.D.a,* a
Department of Surgery, University Medical Center Groningen, University of Groningen, 9700 RB Groningen, The Netherlands; bPolyganics BV, Groningen, The Netherlands KEYWORDS: Colorectal surgery; Surgical anastomosis; Postoperative complication; Surgical staplers
Abstract BACKGROUND: A colorectal anastomotic leak can be life-threatening. We have assessed the feasibility of a new intraluminal biodegradable bypass device that we designed to avoid anastomotic leakage and the necessity of a temporary stoma. METHODS: Fifteen patients underwent colorectal surgery. Before performing the anastomosis in a standard way, the C-Seal (Polyganics BV, Groningen, The Netherlands) was glued to the anvil of the circular stapler. Consequently, the bypass was fixated in the staple row just proximal of the simultaneously made anastomosis. A water-soluble contrast enema was performed after 1 week. RESULTS: The sheath was well compatible with the standard stapler device and easy to use. All donuts remained intact. No radiologic or clinical leaks were observed after surgery. CONCLUSIONS: This pilot study shows that the C-Seal can be applied successfully in colorectal surgery. Further investigation with large numbers of patients is now necessary to assess the efficacy of the C-Seal as a protective device. © 2011 Elsevier Inc. All rights reserved.
Symptomatic leakage of an anastomotic leak is the main surgical complication after colorectal surgery and is associated with a mortality rate of 6% to 22%.1 The complication rate of leakage increases the closer the anastomosis is performed to the anal verge.1– 4 To protect the patient from anastomotic leakage (AL) and its cumbersome complications, the surgeon can choose between a temporary or definitive stoma. Prospective trials have shown that a protective stoma reduces the rate of AL requiring surgical intervention.5–7 A major drawback of a temporary stoma, * Corresponding author. Tel.: ⫹31503612283; fax: ⫹31503614873. E-mail address: [email protected] Manuscript received January 14, 2010; revised manuscript April 5, 2010
0002-9610/$ - see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2010.04.014
however, is that after full recovery the patient will need to receive a second surgery to take the stoma down, with a morbidity and mortality of its own.8 Moreover, in many patients the initial so-called temporary stoma will in fact never be taken down.9,10 Patients with clinically apparent AL represent only a proportion of those who have some form of impairment of integrity when investigated by contrast radiology.11,12 Apparently, small subclinical leaks can heal by themselves. Assuming that a temporary bridging of a brittle anastomosis would minimize the consequences of AL and may allow small leaks to heal better, we developed a novel device and technique to protect anastomoses after distal colorectal surgery. This technique involves the introduction of a biodegradable sheath into the lumen of the intestinal tract, adja-
J.L. Kolkert et al.
Figure 1 anvil.
The C-Seal feasibility study
Schematic drawing of how the C-Seal is glued onto the
cent to its mucosal lining and just proximal of the anastomosis. The sheath is fixated using the circular stapling device currently used in the total mesorectal excision (TME) procedure and ends beyond the anal verge in open air. In this way, fecal diversion is created through an intraluminal bypass. In this report, we describe the results of a feasibility study regarding the use of the C-Seal colonic sheath.
755 secure the anvil shaft. The anastomosis subsequently was performed in the standard way after introducing the stapler into the rectal stump by attaching and approximating the anvil to the stapler. After firing the stapler the device was removed, pulling the C-seal transanally (Fig. 2). The sheath then was cut off the stapler at 5 to 6 cm from the anus. Because the sheath has a thickness of approximately 70 m, it is not necessary to use staples of a different height. One week after surgery, water-soluble, contrast-enema imaging was performed in all patients by the radiologist to see whether any obstruction caused by the sheath or partial separation of the C-Seal from the anastomotic circumference had occurred. Pertinent data of the 15 patients included were registered. Collected data concerned the physical status of the patient (according to the American Society of Anesthesiologists [ASA] classification), indication of intervention, previous treatment for the disorder, concomitant gastrointestinal disorders, and use of medication. All variables concerning the procedure were collected including duration of the entire procedure, additional time for application of the C-Seal, inspection of the donuts including the C-Seal material, and whether a diverting stoma had been created. Also, the performing surgeons were asked to fill out a device appreciation form, indicating the following items: packaging of the material, length of the C-Seal, flexibility, user-friendliness of gluing the C-Seal sheath to the cap of the stapler, ability to staple the anastomosis including the sheath, turning the C-Seal sheath inside-out, and the overall convenience of the procedure. Postoperative data included radiologic or clinical leak, length of in-hospital stay, duration of fragmentation of the C-Seal device, passage of bolus, and discomfort such as pain or incontinence experienced by the patient, as well as any other complication.
Methods A tear-resistant, biodegradable, polyurethane device was used as a protective intracolonic sheath. The polyurethane is composed of D/L lactide– and -caprolactone– based soft segments and 1,4-butanediol– and 1,4-butanediisocyanate– based uniform hard segments. The membrane has a thickness of approximately 70 m. The sheath was introduced after sigmoid or low anterior resection with subsequent primary anastomosis. After approval by the Medical Ethics Committee of the University Medical Center Groningen, 15 patients gave informed consent and were included in this study. All procedures were performed in the standard training setting in our institution with a resident and a supervising surgeon. After the decision to proceed with a stapled anastomosis the anvil of the circular stapler was put into the C-Seal (Fig. 1). The open end of the C-Seal then was glued on the detachable head using a cyanoacrylate tissue adhesive (Dermabond; Ethicon, Inc, Somerville, NJ). The lumen of the afferent colonic loop was opened and the circular stapling anvil with the C-Seal was inserted into the lumen. A purse-string suture was placed to close the lumen and
Figure 2 Schematic drawing of the process of anchoring the sheath proximally to the anastomotic site using the circular stapler.
756 Table 1
The American Journal of Surgery, Vol 201, No 6, June 2011 Patient characteristics
Median age (range) Sex M F Median BMI (range) Comorbidity Cardiovascular Hypertension Pulmonary Obesity Tobacco users Diagnosis Sigmoid cancer Rectal cancer Cancer stage I II III Preoperative radiation Preoperative chemotherapy
70 (55–80) 11 4 26 (22–33) 5 3 2 1 2 5 10 2 5 8 8 1
Results In 15 patients (4 women, 11 men) a low colorectal resection was performed (Table 1). The indication for resection was rectal cancer (n ⫽ 10) or sigmoid cancer (n ⫽ 5). The median age of the patients was 70 years (range, 55– 80 y). The median distance from the anal verge to the tumor was 12 cm (range, 4.5–20 cm). Preoperative radiation therapy had been given to all patients with rectal cancer. The median duration of the surgical procedure was 232 minutes (range, 130 –384 min). Although gluing the drain onto the detachable head was believed to be slightly inconvenient during surgery, the additional time needed for fixation of the drain did not take more than 10 minutes. Application of the C-Seal procedure did not affect resection of the sigmoid or rectum in any way. In 2 patients, the sheath detached from the anvil of the stapler device during withdrawal of the instrument after stapling and had to be pulled out of the anus manually. After stapling the donuts were found to be intact with all tissue layers including the biodegradable polyurethane sheath material. The median distance from the anal verge to the anastomosis was 6 cm (range, 2–10 cm). In 6 of 15 patients with a low anastomosis a diverting stoma was created. No major complications related to the anastomosis were observed after surgery. Patients did not report major discomfort caused by the sheath. A minimal incontinence for loose stool was observed as long as the sheath was in situ. No clinical signs of leakage were seen in any patient. A water-soluble enema through the sheath was performed 1 week after surgery and revealed no signs of radiologic extravasations indicating leakage or any obstruction caused by the C-Seal. One patient developed a long-lasting ileus, requiring re-laparotomy and desufflation of the cecum 3 weeks after the initial surgery. This complication, however, was not related to the C-Seal procedure because the device
had passed with stool after 4 days and the water-soluble contrast enema 8 days after surgery showed no obstruction or leak. In the initial series of 4 patients, the protective sheaths were found to be completely degraded and detached after 5 days. Because this was considered too early, the content of the hydrophilic component in the polyurethane was reduced to reduce the degradation speed. A subsequent second series in 11 patients showed a longer fragmentation period with a median passage of the sheath with stool after 13 days. The median length of hospital stay was 8 days (range, 7–53 d).
Comments The concept of an intraluminal bypass technique to avoid both AL and the use of a temporary deviating stoma after a low colorectal anastomosis was introduced by Ger and Ravo13 during the 1980s. Their procedure consisted of suturing a soft pliable latex tube (Coloshield; Deknatel, Inc, Fall River, MA) to mucosa and submucosa proximal to the anastomotic site using biodegradable suturing material.14,15 Clinical and experimental data have shown that the concept of an intraluminal bypass is safe with only a few complications.14,16,17 Others have tried this concept by using a latex condom as an intraluminal bypass,18 –20 or a soft thin Vicryl tube that is attached to a biodegradable anastomosis ring.21 Our concept of the C-Seal is similar to these previous devices: a soft pliable tube serving as an intraluminal diversion for fecal flow. In contrast to the devices described previously, which are sutured to the bowel wall by hand using biodegradable suture material, the C-Seal is biodegradable itself and compatible with the circular stapling devices currently used for colorectal anastomoses. By this means, stapling, cutting, and attachment of the protective C-Seal are combined, which renders the procedure less time consuming and less invasive. The median duration of the surgical procedure in this study was high, which might be explained by the fact that all procedures were performed in a teaching hospital by surgical residents supervised by senior staff. Moreover, most of the rectal tumors were in an advanced stage, which led to prolonged surgical time as a result of having to perform intricate surgery. The procedure, however, does not differ from our standard procedure except for the gluing of the sheath onto the cap of the detachable head on the circular stapler. The application of the C-Seal device can be performed easily by any surgeon experienced in stapled colorectal anastomoses. Although gluing of the sheath onto the anvil is easy, the particular acrylic-based glue used in this pilot was not favored because the sheath detached in 2 patients while removing the stapler device and the sheath had to be retrieved and pulled through the anus manually. Although this was not a major concern, improvements will be sought in the attachment of the C-Seal to the anvil of the stapler.
J.L. Kolkert et al.
The C-Seal feasibility study
In the healing process of colonic anastomoses, the continuity is established by deposition of a new matrix that bridges the anastomosis. Collagen is the most abundantly present extracellular matrix protein. Between days 1 and 3 after injury, however, there is a weak period in the synthesis of the new matrix owing to an increased breakdown by collagenases. Therefore, immediately after its creation and for 2 to 3 days thereafter, the anastomosis is held together by sutures and sealed by a fibrin clot. The anastomotic strength increases after 3 days and reaches full strength after 7 days.22 Leaks during this period (3–7 d) have been described as early postoperative onset leakages. Leaks during the second week after surgery (days 7–14) are described as late-onset leakages and have been associated with inadequate tissue perfusion of the anastomotic site and a non– tension-free suture line.23,24 Thus, theoretically, the first 2 weeks after surgery are the critical period for the development of an anastomotic leak. An artificial intraluminal barrier during this period prevents a possible leak of fecal contents into the surrounding area. A perforation that originates underneath the sheath still can cause an infection owing to the normal bacterial flora between sheath and rectal wall. However, the extent of infection will be limited because there is no fecal spill. Moreover, inflammation will enhance the development of adhesions or an abscess, frequently with a natural sealing of the perforation and thus containment of infection. Hence, an intraluminal protection device against AL has to be present for approximately 2 weeks. In the first 4 patients our colon sheath degraded and fragmented too early. This rapid fragmentation was quite unexpected because in previous degradation studies in special Sørensen buffers the polyurethane had shown longer rates of degradation and retention of mechanical properties. Apparently, the ex situ screening conditions that had been chosen were not representative of the harsh environment of the colon. Therefore, for the remaining patients we changed the composition of the material to delay degradation, which led to a detachment of the sheath at a median of 13 days after surgery. We assume that at this stage the biodegradable material is weakened and torn away from the anastomotic circumference because of the shear forces on the sheath produced during defecation. In summary, in this pilot study we show that the technical application of the C-Seal as a biodegradable intraluminal protective device in colorectal surgery is feasible. None of the patients developed a clinical or radiologic leak, which is encouraging for the ongoing development of this concept. Before further clinical studies will take place, minor adjustments in the attachment of the C-Seal to the anvil of the stapler have to be performed. Subsequently, a phase II study in a larger population will be conducted to estimate the AL rate using the C-Seal. Assuming results still are encouraging after this phase II study, we think a randomized controlled trial is necessary to show the efficacy of the C-Seal as a
757 protective device to avoid complications from AL and possibly the use of a temporary deviating stoma.
Acknowledgments This study was funded by a Senter grant from the Dutch Ministry of Economic Affairs. This study is registered in the Dutch Trial Registry (NTR-number 1340).
References 1. Rullier E, Laurent C, Garrelon JL, et al. Risk factors for anastomotic leakage after resection of rectal cancer. Br J Surg 1998;85:355– 8. 2. Eriksen MT, Wibe A, Norstein J, et al. Anastomotic leakage following routine mesorectal excision for rectal cancer in a national cohort of patients. Colorectal Dis 2005;7:51–7. 3. Law WL, Chu KW. Anterior resection for rectal cancer with mesorectal excision: a prospective evaluation of 622 patients. Ann Surg 2004;240:260 – 8. 4. Matthiessen P, Hallböök O, Andersson M, et al. Risk factors for anastomotic leakage after anterior resection of the rectum. Colorectal Dis 2004;6:462–9. 5. Gastinger I, Marusch F, Steinert R, et al. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg 2005; 92:1137– 42. 6. Peeters KC, Tollenaar RA, Marijnen CA, et al. Risk factors for anastomotic failure after total mesorectal excision of rectal cancer. Br J Surg 2005;92:211– 6. 7. Wong NY, Eu KW. A defunctioning ileostomy does not prevent clinical anastomotic leak after a low anterior resection: a prospective, comparative study. Dis Colon Rectum 2005;48:2076 –9. 8. Pokorny H, Herkner H, Jakesz R, et al. Mortality and complications after stoma closure. Arch Surg 2005;140:956 – 60. 9. Bailey CM, Wheeler JM, Birks M, et al. The incidence and causes of permanent stoma after anterior resection. Colorectal Dis 2003;5:331–4. 10. den Dulk M, Smit M, Peeters KC, et al. A multivariate analysis of limiting factors for stoma reversal in patients with rectal cancer entered into the total mesorectal excision (TME) trial: a retrospective study. Lancet Oncol 2007;8:297–303. 11. Lim M, Akhtar S, Sasapu K, et al. Clinical and subclinical leaks after low colorectal anastomosis: a clinical and radiologic study. Dis Colon Rectum 2006;49:1611–9. 12. Nesbakken A, Nygaard K, Lunde OC, et al. Anastomotic leak following mesorectal excision for rectal cancer: true incidence and diagnostic challenges. Colorectal Dis 2005;7:576 – 81. 13. Ger R, Ravo B. Prevention and treatment of intestinal dehiscence by an intraluminal bypass graft. Br J Surg 1984;71:726 –9. 14. Ravo B, Ger R. A preliminary report on the intracolonic bypass as an alternative to a temporary colostomy. Surg Gynecol Obstet 1984;159:541–5. 15. Ravo B, Reggio D, Frattaroli FM. Insertion of the Coloshield through a colotomy after completion of a colonic anastomosis. Int J Colorectal Dis 1991;6:46 – 8. 16. Gross E, Eigler FW. [Ravo and Ger intracolonic anastomosis protection. Method, indications and results]. Chirurg 1987;58:678 – 83. 17. Serra J, Capella G, Esquius J, et al. Experimental study of the efficacy of the endoluminal prosthesis in colonic anastomoses. Int J Colorectal Dis 1992;7:21–5. 18. Pisoni M, Leone R, Pugliese R, et al. Intraluminal device for the protection of digestive anastomosis. Dis Colon Rectum 1996;39:1332–3. 19. Ruiz PL, Facciuto EM, Facciuto ME, et al. New intraluminal bypass tube for management of acutely obstructed left colon. Dis Colon Rectum 1995;38:1108 –9.
758 20. Yoon WH, Song IS, Chang ES. Intraluminal bypass technique using a condom for protection of coloanal anastomosis. Dis Colon Rectum 1994;3:1046 –7. 21. Chen TC, Yang MJ, Chen SR, et al. Valtrac-secured intracolonic bypass device: an experimental study. Dis Colon Rectum 1997;40: 1063–7.
The American Journal of Surgery, Vol 201, No 6, June 2011 22. Witte MB, Barbul A. Repair of full-thickness bowel injury. Crit Care Med 2003;31:S538 – 46. 23. Thompson SK, Chang EY, Jobe BA. Clinical review: healing in gastrointestinal anastomoses. Part I. Microsurgery 2006;26:131– 6. 24. Wolf AM, Henne-Bruns D. [Anastomosis dehiscence in the gastrointestinal tract]. Chirurg 2002;73:M118 –9.
Clinical Science
Protection of stapled colorectal anastomoses with a biodegradable device: the C-Seal feasibility study Joe L. Kolkert, M.D.a, Klaas Havenga, M.D., Ph.D.a, Henk O. ten Cate Hoedemaker, M.D.a, Johan Zuidema, B.Sc.b, Rutger J. Ploeg, M.D., Ph.D.a,* a
Department of Surgery, University Medical Center Groningen, University of Groningen, 9700 RB Groningen, The Netherlands; bPolyganics BV, Groningen, The Netherlands KEYWORDS: Colorectal surgery; Surgical anastomosis; Postoperative complication; Surgical staplers
Abstract BACKGROUND: A colorectal anastomotic leak can be life-threatening. We have assessed the feasibility of a new intraluminal biodegradable bypass device that we designed to avoid anastomotic leakage and the necessity of a temporary stoma. METHODS: Fifteen patients underwent colorectal surgery. Before performing the anastomosis in a standard way, the C-Seal (Polyganics BV, Groningen, The Netherlands) was glued to the anvil of the circular stapler. Consequently, the bypass was fixated in the staple row just proximal of the simultaneously made anastomosis. A water-soluble contrast enema was performed after 1 week. RESULTS: The sheath was well compatible with the standard stapler device and easy to use. All donuts remained intact. No radiologic or clinical leaks were observed after surgery. CONCLUSIONS: This pilot study shows that the C-Seal can be applied successfully in colorectal surgery. Further investigation with large numbers of patients is now necessary to assess the efficacy of the C-Seal as a protective device. © 2011 Elsevier Inc. All rights reserved.
Symptomatic leakage of an anastomotic leak is the main surgical complication after colorectal surgery and is associated with a mortality rate of 6% to 22%.1 The complication rate of leakage increases the closer the anastomosis is performed to the anal verge.1– 4 To protect the patient from anastomotic leakage (AL) and its cumbersome complications, the surgeon can choose between a temporary or definitive stoma. Prospective trials have shown that a protective stoma reduces the rate of AL requiring surgical intervention.5–7 A major drawback of a temporary stoma, * Corresponding author. Tel.: ⫹31503612283; fax: ⫹31503614873. E-mail address: [email protected] Manuscript received January 14, 2010; revised manuscript April 5, 2010
0002-9610/$ - see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2010.04.014
however, is that after full recovery the patient will need to receive a second surgery to take the stoma down, with a morbidity and mortality of its own.8 Moreover, in many patients the initial so-called temporary stoma will in fact never be taken down.9,10 Patients with clinically apparent AL represent only a proportion of those who have some form of impairment of integrity when investigated by contrast radiology.11,12 Apparently, small subclinical leaks can heal by themselves. Assuming that a temporary bridging of a brittle anastomosis would minimize the consequences of AL and may allow small leaks to heal better, we developed a novel device and technique to protect anastomoses after distal colorectal surgery. This technique involves the introduction of a biodegradable sheath into the lumen of the intestinal tract, adja-
J.L. Kolkert et al.
Figure 1 anvil.
The C-Seal feasibility study
Schematic drawing of how the C-Seal is glued onto the
cent to its mucosal lining and just proximal of the anastomosis. The sheath is fixated using the circular stapling device currently used in the total mesorectal excision (TME) procedure and ends beyond the anal verge in open air. In this way, fecal diversion is created through an intraluminal bypass. In this report, we describe the results of a feasibility study regarding the use of the C-Seal colonic sheath.
755 secure the anvil shaft. The anastomosis subsequently was performed in the standard way after introducing the stapler into the rectal stump by attaching and approximating the anvil to the stapler. After firing the stapler the device was removed, pulling the C-seal transanally (Fig. 2). The sheath then was cut off the stapler at 5 to 6 cm from the anus. Because the sheath has a thickness of approximately 70 m, it is not necessary to use staples of a different height. One week after surgery, water-soluble, contrast-enema imaging was performed in all patients by the radiologist to see whether any obstruction caused by the sheath or partial separation of the C-Seal from the anastomotic circumference had occurred. Pertinent data of the 15 patients included were registered. Collected data concerned the physical status of the patient (according to the American Society of Anesthesiologists [ASA] classification), indication of intervention, previous treatment for the disorder, concomitant gastrointestinal disorders, and use of medication. All variables concerning the procedure were collected including duration of the entire procedure, additional time for application of the C-Seal, inspection of the donuts including the C-Seal material, and whether a diverting stoma had been created. Also, the performing surgeons were asked to fill out a device appreciation form, indicating the following items: packaging of the material, length of the C-Seal, flexibility, user-friendliness of gluing the C-Seal sheath to the cap of the stapler, ability to staple the anastomosis including the sheath, turning the C-Seal sheath inside-out, and the overall convenience of the procedure. Postoperative data included radiologic or clinical leak, length of in-hospital stay, duration of fragmentation of the C-Seal device, passage of bolus, and discomfort such as pain or incontinence experienced by the patient, as well as any other complication.
Methods A tear-resistant, biodegradable, polyurethane device was used as a protective intracolonic sheath. The polyurethane is composed of D/L lactide– and -caprolactone– based soft segments and 1,4-butanediol– and 1,4-butanediisocyanate– based uniform hard segments. The membrane has a thickness of approximately 70 m. The sheath was introduced after sigmoid or low anterior resection with subsequent primary anastomosis. After approval by the Medical Ethics Committee of the University Medical Center Groningen, 15 patients gave informed consent and were included in this study. All procedures were performed in the standard training setting in our institution with a resident and a supervising surgeon. After the decision to proceed with a stapled anastomosis the anvil of the circular stapler was put into the C-Seal (Fig. 1). The open end of the C-Seal then was glued on the detachable head using a cyanoacrylate tissue adhesive (Dermabond; Ethicon, Inc, Somerville, NJ). The lumen of the afferent colonic loop was opened and the circular stapling anvil with the C-Seal was inserted into the lumen. A purse-string suture was placed to close the lumen and
Figure 2 Schematic drawing of the process of anchoring the sheath proximally to the anastomotic site using the circular stapler.
756 Table 1
The American Journal of Surgery, Vol 201, No 6, June 2011 Patient characteristics
Median age (range) Sex M F Median BMI (range) Comorbidity Cardiovascular Hypertension Pulmonary Obesity Tobacco users Diagnosis Sigmoid cancer Rectal cancer Cancer stage I II III Preoperative radiation Preoperative chemotherapy
70 (55–80) 11 4 26 (22–33) 5 3 2 1 2 5 10 2 5 8 8 1
Results In 15 patients (4 women, 11 men) a low colorectal resection was performed (Table 1). The indication for resection was rectal cancer (n ⫽ 10) or sigmoid cancer (n ⫽ 5). The median age of the patients was 70 years (range, 55– 80 y). The median distance from the anal verge to the tumor was 12 cm (range, 4.5–20 cm). Preoperative radiation therapy had been given to all patients with rectal cancer. The median duration of the surgical procedure was 232 minutes (range, 130 –384 min). Although gluing the drain onto the detachable head was believed to be slightly inconvenient during surgery, the additional time needed for fixation of the drain did not take more than 10 minutes. Application of the C-Seal procedure did not affect resection of the sigmoid or rectum in any way. In 2 patients, the sheath detached from the anvil of the stapler device during withdrawal of the instrument after stapling and had to be pulled out of the anus manually. After stapling the donuts were found to be intact with all tissue layers including the biodegradable polyurethane sheath material. The median distance from the anal verge to the anastomosis was 6 cm (range, 2–10 cm). In 6 of 15 patients with a low anastomosis a diverting stoma was created. No major complications related to the anastomosis were observed after surgery. Patients did not report major discomfort caused by the sheath. A minimal incontinence for loose stool was observed as long as the sheath was in situ. No clinical signs of leakage were seen in any patient. A water-soluble enema through the sheath was performed 1 week after surgery and revealed no signs of radiologic extravasations indicating leakage or any obstruction caused by the C-Seal. One patient developed a long-lasting ileus, requiring re-laparotomy and desufflation of the cecum 3 weeks after the initial surgery. This complication, however, was not related to the C-Seal procedure because the device
had passed with stool after 4 days and the water-soluble contrast enema 8 days after surgery showed no obstruction or leak. In the initial series of 4 patients, the protective sheaths were found to be completely degraded and detached after 5 days. Because this was considered too early, the content of the hydrophilic component in the polyurethane was reduced to reduce the degradation speed. A subsequent second series in 11 patients showed a longer fragmentation period with a median passage of the sheath with stool after 13 days. The median length of hospital stay was 8 days (range, 7–53 d).
Comments The concept of an intraluminal bypass technique to avoid both AL and the use of a temporary deviating stoma after a low colorectal anastomosis was introduced by Ger and Ravo13 during the 1980s. Their procedure consisted of suturing a soft pliable latex tube (Coloshield; Deknatel, Inc, Fall River, MA) to mucosa and submucosa proximal to the anastomotic site using biodegradable suturing material.14,15 Clinical and experimental data have shown that the concept of an intraluminal bypass is safe with only a few complications.14,16,17 Others have tried this concept by using a latex condom as an intraluminal bypass,18 –20 or a soft thin Vicryl tube that is attached to a biodegradable anastomosis ring.21 Our concept of the C-Seal is similar to these previous devices: a soft pliable tube serving as an intraluminal diversion for fecal flow. In contrast to the devices described previously, which are sutured to the bowel wall by hand using biodegradable suture material, the C-Seal is biodegradable itself and compatible with the circular stapling devices currently used for colorectal anastomoses. By this means, stapling, cutting, and attachment of the protective C-Seal are combined, which renders the procedure less time consuming and less invasive. The median duration of the surgical procedure in this study was high, which might be explained by the fact that all procedures were performed in a teaching hospital by surgical residents supervised by senior staff. Moreover, most of the rectal tumors were in an advanced stage, which led to prolonged surgical time as a result of having to perform intricate surgery. The procedure, however, does not differ from our standard procedure except for the gluing of the sheath onto the cap of the detachable head on the circular stapler. The application of the C-Seal device can be performed easily by any surgeon experienced in stapled colorectal anastomoses. Although gluing of the sheath onto the anvil is easy, the particular acrylic-based glue used in this pilot was not favored because the sheath detached in 2 patients while removing the stapler device and the sheath had to be retrieved and pulled through the anus manually. Although this was not a major concern, improvements will be sought in the attachment of the C-Seal to the anvil of the stapler.
J.L. Kolkert et al.
The C-Seal feasibility study
In the healing process of colonic anastomoses, the continuity is established by deposition of a new matrix that bridges the anastomosis. Collagen is the most abundantly present extracellular matrix protein. Between days 1 and 3 after injury, however, there is a weak period in the synthesis of the new matrix owing to an increased breakdown by collagenases. Therefore, immediately after its creation and for 2 to 3 days thereafter, the anastomosis is held together by sutures and sealed by a fibrin clot. The anastomotic strength increases after 3 days and reaches full strength after 7 days.22 Leaks during this period (3–7 d) have been described as early postoperative onset leakages. Leaks during the second week after surgery (days 7–14) are described as late-onset leakages and have been associated with inadequate tissue perfusion of the anastomotic site and a non– tension-free suture line.23,24 Thus, theoretically, the first 2 weeks after surgery are the critical period for the development of an anastomotic leak. An artificial intraluminal barrier during this period prevents a possible leak of fecal contents into the surrounding area. A perforation that originates underneath the sheath still can cause an infection owing to the normal bacterial flora between sheath and rectal wall. However, the extent of infection will be limited because there is no fecal spill. Moreover, inflammation will enhance the development of adhesions or an abscess, frequently with a natural sealing of the perforation and thus containment of infection. Hence, an intraluminal protection device against AL has to be present for approximately 2 weeks. In the first 4 patients our colon sheath degraded and fragmented too early. This rapid fragmentation was quite unexpected because in previous degradation studies in special Sørensen buffers the polyurethane had shown longer rates of degradation and retention of mechanical properties. Apparently, the ex situ screening conditions that had been chosen were not representative of the harsh environment of the colon. Therefore, for the remaining patients we changed the composition of the material to delay degradation, which led to a detachment of the sheath at a median of 13 days after surgery. We assume that at this stage the biodegradable material is weakened and torn away from the anastomotic circumference because of the shear forces on the sheath produced during defecation. In summary, in this pilot study we show that the technical application of the C-Seal as a biodegradable intraluminal protective device in colorectal surgery is feasible. None of the patients developed a clinical or radiologic leak, which is encouraging for the ongoing development of this concept. Before further clinical studies will take place, minor adjustments in the attachment of the C-Seal to the anvil of the stapler have to be performed. Subsequently, a phase II study in a larger population will be conducted to estimate the AL rate using the C-Seal. Assuming results still are encouraging after this phase II study, we think a randomized controlled trial is necessary to show the efficacy of the C-Seal as a
757 protective device to avoid complications from AL and possibly the use of a temporary deviating stoma.
Acknowledgments This study was funded by a Senter grant from the Dutch Ministry of Economic Affairs. This study is registered in the Dutch Trial Registry (NTR-number 1340).
References 1. Rullier E, Laurent C, Garrelon JL, et al. Risk factors for anastomotic leakage after resection of rectal cancer. Br J Surg 1998;85:355– 8. 2. Eriksen MT, Wibe A, Norstein J, et al. Anastomotic leakage following routine mesorectal excision for rectal cancer in a national cohort of patients. Colorectal Dis 2005;7:51–7. 3. Law WL, Chu KW. Anterior resection for rectal cancer with mesorectal excision: a prospective evaluation of 622 patients. Ann Surg 2004;240:260 – 8. 4. Matthiessen P, Hallböök O, Andersson M, et al. Risk factors for anastomotic leakage after anterior resection of the rectum. Colorectal Dis 2004;6:462–9. 5. Gastinger I, Marusch F, Steinert R, et al. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg 2005; 92:1137– 42. 6. Peeters KC, Tollenaar RA, Marijnen CA, et al. Risk factors for anastomotic failure after total mesorectal excision of rectal cancer. Br J Surg 2005;92:211– 6. 7. Wong NY, Eu KW. A defunctioning ileostomy does not prevent clinical anastomotic leak after a low anterior resection: a prospective, comparative study. Dis Colon Rectum 2005;48:2076 –9. 8. Pokorny H, Herkner H, Jakesz R, et al. Mortality and complications after stoma closure. Arch Surg 2005;140:956 – 60. 9. Bailey CM, Wheeler JM, Birks M, et al. The incidence and causes of permanent stoma after anterior resection. Colorectal Dis 2003;5:331–4. 10. den Dulk M, Smit M, Peeters KC, et al. A multivariate analysis of limiting factors for stoma reversal in patients with rectal cancer entered into the total mesorectal excision (TME) trial: a retrospective study. Lancet Oncol 2007;8:297–303. 11. Lim M, Akhtar S, Sasapu K, et al. Clinical and subclinical leaks after low colorectal anastomosis: a clinical and radiologic study. Dis Colon Rectum 2006;49:1611–9. 12. Nesbakken A, Nygaard K, Lunde OC, et al. Anastomotic leak following mesorectal excision for rectal cancer: true incidence and diagnostic challenges. Colorectal Dis 2005;7:576 – 81. 13. Ger R, Ravo B. Prevention and treatment of intestinal dehiscence by an intraluminal bypass graft. Br J Surg 1984;71:726 –9. 14. Ravo B, Ger R. A preliminary report on the intracolonic bypass as an alternative to a temporary colostomy. Surg Gynecol Obstet 1984;159:541–5. 15. Ravo B, Reggio D, Frattaroli FM. Insertion of the Coloshield through a colotomy after completion of a colonic anastomosis. Int J Colorectal Dis 1991;6:46 – 8. 16. Gross E, Eigler FW. [Ravo and Ger intracolonic anastomosis protection. Method, indications and results]. Chirurg 1987;58:678 – 83. 17. Serra J, Capella G, Esquius J, et al. Experimental study of the efficacy of the endoluminal prosthesis in colonic anastomoses. Int J Colorectal Dis 1992;7:21–5. 18. Pisoni M, Leone R, Pugliese R, et al. Intraluminal device for the protection of digestive anastomosis. Dis Colon Rectum 1996;39:1332–3. 19. Ruiz PL, Facciuto EM, Facciuto ME, et al. New intraluminal bypass tube for management of acutely obstructed left colon. Dis Colon Rectum 1995;38:1108 –9.
758 20. Yoon WH, Song IS, Chang ES. Intraluminal bypass technique using a condom for protection of coloanal anastomosis. Dis Colon Rectum 1994;3:1046 –7. 21. Chen TC, Yang MJ, Chen SR, et al. Valtrac-secured intracolonic bypass device: an experimental study. Dis Colon Rectum 1997;40: 1063–7.
The American Journal of Surgery, Vol 201, No 6, June 2011 22. Witte MB, Barbul A. Repair of full-thickness bowel injury. Crit Care Med 2003;31:S538 – 46. 23. Thompson SK, Chang EY, Jobe BA. Clinical review: healing in gastrointestinal anastomoses. Part I. Microsurgery 2006;26:131– 6. 24. Wolf AM, Henne-Bruns D. [Anastomosis dehiscence in the gastrointestinal tract]. Chirurg 2002;73:M118 –9.