Use Of Small Intestinal Submucosa Research Articles

Extracellular Matrix Patches for Endarterectomy Repair.

Patch repair is the preferred method for arteriotomy closure following femoral or carotid endarterectomy. Choosing among available patch options remains a clinical challenge, as current evidence suggests roughly comparable outcomes between autologous grafts and synthetic and biologic materials. Biologic patches have potential advantages over other materials, including reduced risk for infection, mitigation of an excessive foreign body response, and the potential to remodel into healthy, vascularized tissue. Here we review the use of decellularized extracellular matrix (ECM) for cardiovascular applications, particularly endarterectomy repair, and the capacity of these materials to remodel into native, site-appropriate tissues. Also presented are data from two post-market observational studies of patients undergoing iliofemoral and carotid endarterectomy patch repair as well as one histologic case report in a challenging iliofemoral endarterectomy repair, all with the use of small intestine submucosa (SIS)-ECM. In alignment with previously reported studies, high patency was maintained, and adverse event rates were comparable to previously reported rates of patch angioplasty. Histologic analysis from one case identified constructive remodeling of the SIS-ECM, consistent with the histologic characteristics of the endarterectomized vessel. These clinical and histologic results align with the biologic potential described in the academic ECM literature. To our knowledge, this is the first histologic demonstration of SIS-ECM remodeling into site-appropriate vascular tissues following endarterectomy. Together, these findings support the safety and efficacy of SIS-ECM for patch repair of femoral and carotid arteriotomy.

Re: Use of Small Intestinal Submucosa for Corporal Body Grafting in Cases of Epispadias and Epispadias/Exstrophy Complex.

No AccessJournal of UrologyUrological Survey1 Jul 2020Re: Use of Small Intestinal Submucosa for Corporal Body Grafting in Cases of Epispadias and Epispadias/Exstrophy Complex Douglas A. CanningMD Douglas A. CanningDouglas A. Canning More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001049.04AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "Re: Use of Small Intestinal Submucosa for Corporal Body Grafting in Cases of Epispadias and Epispadias/Exstrophy Complex." The Journal of Urology, 204(1), pp. 174–175 Reference 1. : Bladder exstrophy closure and epispadias repair. In: Rob and Smith’s Operative Surgery: Pediatric Surgery, 4th ed. Edited by . Boston: Butterworths 1988; pp 620–622. Google Scholar © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 204Issue 1July 2020Page: 174-175 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Douglas A. Canning More articles by this author Expand All Advertisement PDF downloadLoading ...

Use of small intestinal submucosa for corporal body grafting in cases of epispadias and epispadias/exstrophy complex

Male epispadias is a rare congenital urogenital anomaly in which the meatus is ectopically located along the dorsal midline of the penile shaft. In cases associated with severe curvature, functional and cosmetic outcomes could be accomplished by lengthening the shorter dorsal surface with the use of corporal grafting. Various graft materials have been used in the past for hypospadias repair including tunica vaginalis, dermis, and small intestinal submucosa (SIS). The use of SIS grafting for corporoplasty during epispadias repair has rarely been described in the literature. To report the experience in the management of dorsal corporal body grafting using SIS in children with severe penile curvature due to epispadias. The authors retrospectively reviewed the charts of all patients with epispadias or bladder exstrophy/epispadias complex and severe dorsal chordee (>40°) who underwent epispadias repair with single-layer SIS for corporal body grafting. Clinical variables, surgical technique, and outcomes were analyzed. A total of nine consecutive patients underwent staged epispadias repair with dorsal corporal single-layer SIS grafting (summary figure). Of these, four (44.4%) had primary penopubic epispadias, one (11.1%) had mid-shaft epispadias, and four (44.4%) had bladder exstrophy/epispadias complex. The mean age at surgery was 13.4±6 months. After phalloplasty with SIS grafting, there were no reported complications related to the graft during the post-operative period or follow-up visits. Although traditional techniques for epispadias repair allow some degree of corporal lengthening, they also result in abrupt medial rotation of the corporal bodies leading to torqueing and potential unsatisfactory cosmetic results. In contrast, the authors use single-layer SIS for corporal body grafting, and this study technique results in a more gradual inward rotation thus allowing more anatomical accuracy. Furthermore, an advantage of the use of SIS over other grafting materials is that there is no need to harvest an autologous graft such as tunica vaginalis or dermis. Epispadias repair using single-layer SIS corporal body grafting is an effective, safe, and feasible method, which provides satisfactory cosmesis and correction of dorsal curvature in congenital epispadias in children. Furthermore, a more normal penis appearance, without a decrease in the corporal length or diameter, is achieved with this technique.

Complications following Staged Hypospadias Repair Using Transposed Preputial Skin Flaps

Proximal hypospadias repair using a staged approach is a complex reconstructive operation with the potential for significant complications requiring repeat surgery. We report outcomes of staged hypospadias repair using transposed preputial skin flaps and factors predictive of postoperative complications. We retrospectively analyzed patients who underwent staged proximal hypospadias repair using transposed preputial skin flaps between 2002 and 2013. Patient demographics, operative details, complications, reoperations and factors predictive of complications were reviewed. A total of 56 patients were identified with a mean age of 14.1 months (median 14.3) at first stage. Mean followup was 38.6 months (median 34.1). Complications requiring additional unplanned operation(s) were observed in 38 patients (68%), including fistulas in 32 (57%), diverticula in 8 (14%), meatal stenosis in 5 (9%), urethral stricture in 8 (14%) and glans dehiscence in 3 (5%). In addition, redo first stage repair was performed in 4 patients (7%). Since some patients had more than 1 complication, the total number of complications is greater than the number of patients undergoing a redo operation. On univariate analyses the use of small intestinal submucosa was significantly associated with an increased risk of fistula (91% vs 49%, p = 0.02) and urethral diverticulum (64% vs 24%, p = 0.04). Incision of the tunica albuginea of the corpora was associated with an increased likelihood of fistula (77% vs 44%, p = 0.03). Finally, patients with glans dehiscence were significantly younger at first stage (5.8 vs 14.8 months, p = 0.01). The reoperation rate for complications in children undergoing staged hypospadias repair using transposed preputial skin flaps is higher than previously reported.

Bladder augmentation with small intestinal submucosa leads to unsatisfactory long-term results

PurposeTo evaluate the use of small intestinal submucosa (SIS) for bladder augmentation in a series of select patients. Material and methodsSix patients (age 6.5–15.4, mean 9.8 years) underwent bladder augmentation with SIS: one after a cloacal exstrophy repair, one after multiple surgery of the bladder because of vesicoureteral reflux, two with spina bifida, two after bladder exstrophy repair. All suffered from a microbladder with a mean volume of 61.5 ml (range 15–120, 7–36% of expected bladder capacity for age). Preoperative bladder compliance ranged from 1.0 to 3.3 (mean 1.3) ml/cmH2O. ResultsFollow-up time ranged from 4.6 to 33.5 (mean 24.4) months. An increase of bladder volume was achieved in four patients (53–370 ml, 16–95% of expected bladder capacity for age). Bladder compliance postoperatively ranged from 0.9 to 5.6 (mean 3.0) ml/cmH2O. Histological examinations showed a complete conversion of SIS, leaving irregular urothelial lining and bladder wall containing muscular, vascular and relatively thick connective tissue in four patients and regular urothelium in two patients. Major complications were bladder stones in two patients and a bladder rupture in one patient. ConclusionBladder augmentation with SIS in humans failed to fulfill the hopes raised by animal studies. Due to the insufficient increase in bladder compliance and therefore failure to accomplish sufficient protection of the upper urinary tract, bladder augmentation with SIS cannot be recommended as a substitute for enterocystoplasty.

Hiatal Hernia Repair With the Use of Biologic Meshes

During the past few years, biologic meshes, primarily evolved for routine and complex cases of abdominal wall reconstruction, have been evaluated in clinical cases and experimental models. Although there is published experience on the use of small intestine submucosa and human cadaveric dermis in hiatal hernia repair with encouraging results, porcine dermal collagen (PDC) matrix has not been subject of study to date in this patient population. A systematic review of the literature was conducted, aiming at evaluating the biomechanical characteristics of cross-linked PDC in comparison to synthetic and biologic meshes. Evidence shows that cross-linked PDC is superior to synthetic meshes in terms of incorporation, adhesion formation, and mesh fibrosis; their biodynamic and biotechnical characteristics do not seem to be superior to other bioprosthetic materials according to current data. The clinical and experimental results of cross-linked PDC implants justify their pilot clinical evaluation in hiatal hernia patients.

The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up

The treatment of hernias remains controversial, with multiple prosthetic meshes being exalted for a variety of their characteristics. In the event of incarcerated/strangulated hernias and other potentially contaminated fields the placement of prosthetic material remains controversial because of increased risk of recurrence and infection. Porcine small intestinal submucosa mesh (Surgisis, Cook Bloomington, IN) has been demonstrated safe and feasible in laparoscopic hernia repairs in this scenario. We present our 5-year experience, with placement of Surgisis mesh in potentially or grossly contaminated fields. From May 2000 to October 2006, 116 patients (52 male, 64 female) with 133 procedures were performed. Placement of Surgisis mesh for either incisional, umbilical, inguinal, femoral or parastomal hernia repairs in an infected or potentially contaminated setting were achieved, and studied in a prospective fashion. All procedures were laparoscopically with two techniques [intraperitoneal onlay mesh (IPOM) and two-layered "sandwich" repair]. Mean follow-up was 52 +/- 20.9 months. Thirty-nine cases were in an infected field and the rest in a potentially contaminated field. Ninety-one procedures were performed concurrently with a contaminated procedure. Twenty-five presented as intestinal obstruction, 16 strangulated hernias, and 17 required small bowel resection; 29 were inguinal hernias, 57 incisional, and 38 umbilical. In 13 patients more than two different hernias were repaired. Eighty-five percent 5-year follow-up was achieved, during which we identified 7 recurrences, 11 seromas (all resolved), and 10 patients reporting mild pain. Six second looks were performed and in all cases except one the mesh was found to be totally integrated into the tissue with strong scar tissue corroborated macro- and microscopically. In our experience the use of small intestine submucosa mesh in contaminated or potentially contaminated fields is a safe and feasible alternative to hernia repair with minimal recurrence rate and satisfactory results in long-term follow-up.

Small Intestinal Submucosa for Corporeal Body Grafting in Severe Hypospadias Requiring Division of the Urethral Plate

Severe chordee associated with proximal hypospadias is a challenging problem. Occasionally division of the urethral plate and corporeal body grafting are necessary to achieve a straight phallus. We report our experience with small intestinal submucosa for corporeal body grafting to correct severe chordee associated with proximal hypospadias. We reviewed the charts of all 28 patients who underwent small intestinal submucosa corporeal body grafting to correct severe chordee during stage 1 of planned 2-stage proximal hypospadias repair from January 2001 to June 2006. After mobilization and division of the urethral plate ventral horizontal corporotomies were performed at the site of maximum curvature. Four and 1 ply small intestinal submucosa in 21 and 7 cases, respectively, was then fashioned to size and secured into the defect. Preoperative, operative and postoperative clinic visit records were reviewed to assess outcomes. Preoperatively the meatal position was penoscrotal in 18 patients, scrotal in 5 and perineal in 5. In all patients, who had a mean age of 16 months, the urethral plate was divided and the corporeal bodies were grafted during stage 1 surgery. Vascularized preputial flaps were rotated ventrally for subsequent urethroplasty in 25 patients and buccal mucosa was used for urethroplasty in the remaining 3. A total of 26 patients underwent stage 2 repair with a mean followup of 38 months (range 6 to 61). Overall there were 6 complications, including epidermal retention cysts in 2 cases, partial urethral dehiscence in 2 and urethral diverticulum requiring reduction urethroplasty in 1, while a perimeatal granuloma developed in 1 following stage 1 repair, which required excision. Except the possibility of this latter patient there were no complications related to the small intestinal submucosa graft and a straight phallus without fibrosis was achieved in all 26. Our experience suggests that small intestinal submucosa is a suitable material for corporeal body grafting in 2-stage hypospadias repairs when there is associated severe chordee. In rare instances in which other maneuvers are inadequate to correct chordee small intestinal submucosa grafting is a reasonable option and a low complication rate can be anticipated.

Use of small intestine submucosa in a rat model of acute and chronic rotator cuff tear

Augmentation materials for rotator cuff tears, such as small intestine submucosa (SIS), have been used with the goal of improving outcome. Knowledge is limited on the use of SIS in animal models of acute and chronic rotator cuff tears. We hypothesized that the use of SIS in the surgical management of full thickness supraspinatus tears would improve histologic and biomechanical properties. Results show temporal improvements in several histologic parameters. Both acute and chronic injuries repaired with SIS have similar and increased mechanical properties respectively, compared to those repaired without SIS. In general, acute repairs with SIS were comparable to acute repairs without SIS. In chronic repairs, the use of SIS significantly reduced the cross sectional area of the healing tendon and increased the modulus. These results provide information on the use of SIS for rotator cuff repairs.

Small Intestinal Submucosa (SIS) Graft Urethroplasty: Short-term Results

ObjectiveWe evaluated the use of small intestinal submucosa (SIS) graft in penile and bulbar urethroplasties. MethodsFrom 2003 to 2004, 20 men (mean age, 41 yr) with anterior urethral strictures underwent urethroplasty using SIS (COOK®) as an inlay or onlay patch graft. Stricture location was penile in 1 patient, bulbar in 16, and penile-bulbar in 3. Average stricture and graft lengths were 3 and 5.7cm, respectively. A dorsal inlay graft was performed in 14 cases, ventral onlay graft in 1, and dorsal inlay plus ventral onlay in 5. Clinical outcome was considered successful if no postoperative procedure was needed. ResultsMean follow-up period was 21 mo (range: 13–35 mo). Seventeen cases (85%) were successful and 3 (15%) were failures. No postoperative complications were related to the use of heterologous graft material, such as infection or rejection. Sixteen successes (94%) were bulbar repairs and one a penile-bulbar repair, with stricture and graft average lengths 2.6 and 5.35cm, respectively. Cystoscopy at 3 mo revealed adequate calibre lumens, but SIS grafted areas were not completely replaced by urothelium. The three failures were penile and penile-bulbar urethral repairs with stricture and graft average lengths of 5.7 and 7.7cm, respectively. Recurrences showed fibrous tissue involving the grafted area with extension into the penile and bulbar urethra. ConclusionsIn our short-term results, SIS seems to be a versatile material that may have a role in select urethral reconstructions. Longer follow-up and further investigations in select patients are needed before widespread use is advocated.

The whole truth: comparative analysis of diaphragmatic hernia repair using 4-ply vs 8-ply small intestinal submucosa in a growing animal model

Background Diaphragmatic reconstruction remains a challenging problem. There is limited information concerning the use of small intestinal submucosa (SIS) in congenital diaphragmatic hernia repair. A canine model was used to evaluate the use of a SIS patch in diaphragmatic reconstruction. Methods Eleven beagle puppies (1.6-4.2 kg, 8 weeks old) underwent left subcostal laparotomy, central left hemidiaphragm excision (2 × 7 cm, 50% loss), and reconstruction with a 4-ply group I (n = 5) or 8-ply group II (n = 6) SIS patch. Chest radiographs were taken at time of operation and 3 and 6 months postoperatively. Animals were killed at 6 months. Adhesion formation (both pleural and abdominal), gross visual evaluation of the patch, and histology were compared. Results In group I (4-ply), 1 animal died at 3 months from patch deterioration accompanied by stomach herniation that resulted in respiratory failure. In the 4 remaining animals, chest radiographs showed no evidence of herniation or eventration. On physical examination, there was no evidence of chest wall deformity. During gross surgical examination, the 4-ply patches showed thinning, multiple defects, and liver herniation in 3 animals. In 1 pup, the patch was thickened, intact, well incorporated at the repair site, and adherent to the liver and spleen. In group II (8-ply), 1 animal died of cardiopulmonary failure in the early postoperative period. In the other 5 animals, chest radiographs showed evidence of eventration in 1. On gross examination the patch adhered to the liver in all 5 surviving animals. In 4, the patches were thickened, viable, but had some shrinkage. One patch pulled away from the native diaphragm laterally; however, no visceral herniation was present. In the 1 animal with eventration, there was no evidence of a patch. Adhesion scores (AS) were graded and determined by the sum of extent (0-4), type (0-4), and tenacity (0-3). Average abdominal AS in group I was 5.6 ± 0.8 vs 10.2 ± 0.2 ( P = .079) for group II. Average lung AS was 0.6 ± 0.6 in group I vs 3.8 ± 1.1 ( P = .0476) for group II. Histological examination showed group II patches had greater collagen deposition with central calcification and mild inflammation within the residual graft, whereas group I patches were much thinner and were composed of granulation tissue without evidence of residual graft. Conclusions These data indicate that 8-ply SIS repair of diaphragmatic defects was superior (80%; 4/5 to 4-ply, 20%; 1/5, success). Organ adherence appears to be necessary for neovascularization of the SIS composite. Eight-ply grafts appear to be more durable and persist for a longer period, which may improve neovascularization. Long-term follow-up to evaluate remodeling characteristics of the patch material is required.

The use of small intestinal submucosa as an off-the-shelf urethral sling material for pediatric urinary incontinence.

Use of autologous rectus fascia for urethral slings in the pediatric population has produced reliable and predictable results. However, the potential morbidity and complications associated with harvesting the autologous rectus fascia have driven efforts to find a reliable off-the-shelf material for urethral slings. Small intestinal submucosa is a collagen based material that has been shown to promote tissue specific regeneration in a variety of organs. We report the clinical experience at 4 institutions with small intestinal submucosa for urethral slings. A total of 20 patients 3 to 18 years old (mean age 8.7) received urethral slings using the commercially available form of small intestinal submucosa (STRATASIS, Cook Urologic Spencer, Indiana) via a sling suspension procedure from a suprapubic approach. The material was consistently uniform to work with and user-friendly. All 20 patients tolerated the procedure well with no intraoperative complications. Postoperative followup has ranged from 9 to 26 months (mean 13), and 14 (70%) patients are completely dry (85% in females and 43% in males). Of the 14 dry patients 13 are on intermittent catheterization and 1 female with epispadias voids spontaneously. This report is the largest and longest followup series using small intestinal submucosa as an "off the shelf" urethral sling material in children. These continence rates are equal to autologous fascia without additional morbidity of graft harvest.

Use of small intestinal submucosa for corporal body grafting in cases of severe penile curvature.

Small intestinal submucosa is a unique biomaterial that has been found to promote tissue specific regeneration in the urinary tract. We present our experimental and clinical experience with small intestinal submucosa (SurgiSis, Cook Biotech, Spencer, Indiana) for pediatric corporal body reconstruction. A total of 20 Fischer rats underwent implantation of a 7 x 3 mm. small intestinal submucosa graft following excision of an ellipse of tunica albuginea and 14 control animals underwent tunical excision with reimplantation of this autologous segment. The animals were euthanized, and the penis was sectioned and histologically studied at intervals of 1, 2, 4, 6, 16 and 24 weeks. In 15 pediatric patients small intestinal submucosa was used for corporal body grafting. The grafting procedure was performed along the ventral (hypospadias cases) or dorsal (epispadias cases) surface of the corporal bodies. The tunica albuginea was incised full thickness at the point of maximal curvature down to the cavernosal tissue and the defect was filled with a single layer of small intestinal submucosa. Measurements of the animal small intestinal submucosa grafts did not reveal significant graft contraction through 6 months. There was no graft expansion or ballooning after pharmacological induction of an artificial erection. Histologically, marked inflammation at 1 week precipitously decreased to a normal appearing tunica albuginea at 3 and 6 months. In all clinical cases small intestinal submucosa was found to be technically easy to handle. Mean followup is 14 months (range 5 to 26). All patients have a straight phallus as documented by observation of spontaneous erections or artificial erection at the time of stage 2 hypospadias repair. No complications occurred. Small intestinal submucosa demonstrates tissue specific regeneration properties in the rat and human tunica albuginea. It is an off-the-shelf material that is safe, technically easy to use and readily available.

Tympanic Membrane Perforation Repair with Acellular Porcine Submucosa

To evaluate the efficacy of acellular porcine small intestine submucosa in the repair of chronic tympanic membrane perforations. Although tympanoplasty with autologous temporalis fascia and cartilage is common practice in the repair of chronic tympanic membrane perforations, these materials are associated with increased operative time and have variable availability and quality in individual patients. Recently, new materials for tympanoplasty have been explored, including acellular human dermis. Small intestine submucosa (Surgisis) is an inexpensive and readily available alternative to autologous and cadaveric grafts. In this study, we examined the use of small intestine submucosa in the repair of chronic tympanic membrane perforations in a chinchilla model. Prospective pilot study using 10 adult chinchillas. Chronic tympanic membrane perforations were created in 10 adult chinchillas for a total of 20 perforations. Each animal underwent observation in one ear and repair with either autologous cartilage or small intestine submucosa in the opposite ear with Type I tympanoplasty. A total of 20 chronic membrane perforations were created, with zero healing spontaneously after 8 weeks. In tympanoplasties performed in five chinchillas with small intestine submucosa, five of five (100%) remained healed 6 weeks postoperatively, whereas three of five (60%) remained healed with cartilage repair. Histologic analysis was performed in both successful cartilage and small intestine submucosa repairs. These results suggest that small intestine submucosa is a viable alternative to autologous and cadaveric grafts in tympanoplasty. A larger randomized study in humans is indicated to evaluate this material in clinical practice.

Use of small intestine submucosa as ureteral allograft in pigs

The aim of the present study was to evaluate the biocompatibility of small intestine submucosa (SIS) in the reconstruction of the ureter in swine. An experimental study was performed in 10 half-breed pigs weighing between 20 and 30 K, in which a previously prepared segment of SIS measuring approximately 2.0 cm was implanted in the upper third part of the right ureter. Of the 10 operated animals, one died 14 days after the surgery due to a dehiscence on the suture line of the implanted graft. The remaining 9 animals were submitted to ultrasound examination of the urinary tract and were sacrificed on the 40th postoperative day. The macroscopic evaluation showed no calculus, incrustation, fistula, abscesses or adhesions in the ureters with the graft. Microscopic evaluation with hematoxylin-eosin and Sirius red showed in the experimental area (graft) the presence of urothelium in 100% of the cases, collagen in 100% of the cases, and smooth muscle layer in 87.5% of the animals. In the area adjacent to the graft (proximal and distal), we observed 92.86% of urothelium, 42.86% of collagen and 71.43% of smooth muscle. In the contralateral ureter, it was found 100% of urothelium and smooth muscle and just 11.11% of collagen. The microscopic analysis of the kidneys whose ureters received the graft of SIS evidenced congestion in 55.55%, pelvic edema in 66.66% and interstitial nephritis in 77.78%. Hydronephrosis was present in 33.33% and chronic pyelonephritis in 44%. Only 1 animal presented total absence of glomerulus in the renal parenchyma. The SIS graft behaved as a biological tissue support, allowing the regeneration of the urothelium and smooth muscle grow, despite of chronic inflammatory process.

Small intestinal submucosa does not promote PAIII tumor growth in Lobund-Wistar rats

Background Site-specific remodeling and angiogenesis are two observations associated with the use of small intestinal submucosa (SIS) as a tissue repair graft. Its angiogenic capacity has raised questions concerning its effect on tumor growth and metastasis in clinical tumor resection cases. The effect of SIS on the ability of neoplastic (prostate adenocarcinoma) cells to establish, grow, and metastasize was examined in Lobund-Wistar (L-W) rats. Materials and methods In one study, SIS, expanded polytetrafluoroethylene (ePTFE), or human cadaveric dermis was placed in a subcutaneous pocket on the flank of L-W rats and immediately inoculated with PA-III cell suspension. Tumors were allowed to establish and metastasize for 5 weeks prior to sacrifice. Rate of tumor growth, tumor weight, and frequency of lung metastases were assessed. In a second study, SIS was placed in a resected tumor bed and tumors were allowed to recur. Rate of tumor growth, tumor weight, and frequency of lung metastases were assessed after 3 weeks. Results ePTFE hastened the rate of formation of palpable tumors compared to controls and other materials; cadaveric dermis and SIS did not. No differences between materials were noted in final tumor weight nor in the frequency of metastasis to the lungs. Following surgical tumor resection, residual tumor cells led to recurrence of same-site tumors in all animals, but in the defects augmented with SIS, the tumors were significantly smaller than those which regrew in the resected, unaugmented group. Conclusions This study demonstrates that SIS does not enhance tumor establishment, growth, or metastasis in de novo tumors. Furthermore, SIS appears to reduce the rate of tumor growth, but not metastasis, when applied in direct contact with a residual tumor bed in a rat model of prostate-related tumors.

Use of Single Layer Small Intestinal Submucosa for Long Segment Ureteral Replacement: A Pilot Study.

Previous studies have demonstrated successful use of small intestinal submucosa (SIS) as a tube for replacing short segment (11 mm) proximal ureteral defects. However, such small segment ureteral defects could be managed by resection re-anastomosis. We evaluated the use of 1-layer SIS as a tube for the replacement of long segment ureteral defects. The ureters of 5 female mongrel dogs were accessed through a median laparotomy incision. A 4 cm segment of mid ureter was resected on the right side. The right ureteral segments were replaced by tubularized SIS segments using 6-zero polydioxanone interrupted sutures. Internal pigtail stents were left for 6 weeks. All animals were sacrificed at 12 weeks. Ureteral patency was assessed by excretory urography and magnetic resonance urography 7 and 12 weeks after the initial procedures. Inflammation and regeneration were assessed histologically. At 12 weeks all ureters on the experimental side were completely occluded with significant hydroureteronephrosis and the subsequent deterioration of kidney function. At autopsy there was failure to calibrate any of the experimental ureters with a 3Fr catheter. Although histologically urothelium and muscular cells had proliferated over the graft, they were embedded in an intense fibrotic and inflammatory process. Technically 1-layer SIS was easily modeled, providing the conditions for watertight anastomosis. The regeneration of urothelium and muscle was induced and supported by the graft. However, functional replacement was not successful. One-layer SIS is not a suitable material for replacing long segment (4 cm) ureteral defects.

The use of small intestine submucosa in the repair of paraesophageal hernias: initial observations of a new technique

Background Recent reports suggest that when laparoscopy is used to repair paraesophageal hernias recurrence rates reach 20% to 40%. Tension-free hernia closure with synthetic mesh reduces recurrence but occasionally results in esophageal injury. We hypothesized that reinforcement of the hiatal closure with small intestine submucosa (SIS) mesh, in some unusually large hernias, might reduce recurrence rates without causing injury to the esophagus. Methods From January 2001 to March 2002 we treated 18 large paraesophageal hernias via a laparoscopic approach. In 9 of the largest hernias (one type II and 8 type III, of which 1 was recurrent) the repair was reinforced with SIS mesh (Surgisis, Cook Surgical) and represent the subjects of this study. Nissen fundoplication with gastropexy was performed in all patients. Clinical follow-up ranged from 3 to 16 months (median 8). Every patient was evaluated with barium esophagram or endoscopy or both 1 to 8 months (median 2) postoperatively. Results The presenting symptoms were postprandial pain/fullness (9 of 9), heartburn (4 of 9), anemia (4 of 9), dysphagia (3 of 9), regurgitation (3 of 9), and chest pain (3 of 9). One patient died of a hemorrhagic stroke within 30 days of the operation. Postoperatively, presenting symptoms resolved (83%) or improved (17%) in each of the remaining 8 patients. One patient required endoscopic dilation for mild dysphagia. Seven of 8 patients had a normal barium esophagram without evidence of hernia. One morbidly obese (body mass index = 47) patient had a small (2 cm) sliding hiatal hernia postoperatively. There were no other complications, and specifically no perforations or mesh erosions. Conclusions These observations suggest that the use of SIS in the repair of paraesophageal hernias is safe and may reduce recurrence. Longer follow-up and a randomized study are needed to validate these results.

Use of Small Intestinal Submucosa for Corporal Body Grafting in Cases of Severe Penile Curvature

Use of Small Intestinal Submucosa for Corporal Body Grafting in Cases of Severe Penile Curvature

The Use of Small Intestinal Submucosa as an off-the-shelf Urethral Sling Material for Pediatric Urinary Incontinence

The Use of Small Intestinal Submucosa as an off-the-shelf Urethral Sling Material for Pediatric Urinary Incontinence