Small Intestinal Submucosa Graft Research Articles

MP-02.11: Application of small intestinal submucosa graft in repair of complicated vesico-vaginal fistula: pilot study

MP-02.11: Application of small intestinal submucosa graft in repair of complicated vesico-vaginal fistula: pilot study

Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy

This study seeks to compare the small intestine submucosa (SIS) graft with traditional colporrhaphy (TC) for surgical treatment of anterior vaginal prolapse. Subjects were randomly assigned to SIS (n = 29) or to TC (n = 27) preoperatively and outcomes analyzed at 12 months postoperatively. The primary outcome was the absence of POP-Q stage >or= II prolapse, and secondary outcome was improvement in quality of life. Data were compared with independent samples or paired Student's t test. SIS group had 86.2% anatomic cure compared to 59.3% in TC (p = 0.03). SIS improved point Ba measurement significantly (-1.93 cm versus -1.37 cm, p = 0.02). Both operations significantly improved quality of life, although there were no differences between the groups. We observed a greater number of complications in the SIS group, with no infections or erosion. SIS repair improved point Ba significantly. However, there were no differences observed in quality of life between the techniques.

Regional variations in small intestinal submucosa evoke differences in inflammation with subsequent impact on tissue regeneration in the rat bladder augmentation model

To examine the histological differences in the inflammatory response and regenerative outcomes of distal vs proximal porcine small intestinal submucosa (SIS) grafts in the rat bladder, as SIS from distal small intestine yields reliable and reproducible bladder regeneration, while SIS from proximal portions of small intestine does not provide similar results. In all, 30 Sprague-Dawley rats underwent hemi-cystectomy followed by anastomosis of a bladder patch of SIS prepared from either distal or proximal small intestine. After bladder harvest, immunohistochemistry was used to quantify mast cells, eosinophils, macrophages, and neutrophils (PMNs). Total cell count per unit area was compared across the time course in univariate and logistic regression modelling. There were more eosinophils and mast cells in proximal SIS grafts, while there were more macrophages and PMNs in distal SIS grafts (all P < 0.05). Trichrome analysis showed increased collagen deposition in proximal SIS grafts and little smooth muscle regeneration. There was also significant graft contracture in proximal SIS grafts compared with distal SIS grafts (P < 0.05). We conclude that the location of SIS origin may evoke different inflammatory responses, which results in altered bladder tissue regeneration.

1228 PREOPERATIVE AND POSTOPERATIVE ERECTILE FUNCTION IN PATIENTS UNDERGOING PEYRONIES PLAQUE INCISION AND GRAFTING

You have accessJournal of UrologyTrauma/Reconstruction: Trauma & Reconstructive Surgery IV1 Apr 20101228 PREOPERATIVE AND POSTOPERATIVE ERECTILE FUNCTION IN PATIENTS UNDERGOING PEYRONIES PLAQUE INCISION AND GRAFTING Benjamin Whittam, Todd Doran, Melissa Kaufman, and Douglas Milam Benjamin WhittamBenjamin Whittam More articles by this author , Todd DoranTodd Doran More articles by this author , Melissa KaufmanMelissa Kaufman More articles by this author , and Douglas MilamDouglas Milam More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.751AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Surgical treatment of Peyronies disease is aimed at correction of penile deformity while preserving erectile function. Review of the current literature indicates this series is the first reported data to use the widely accepted Sexual Inventory in Men (SHIM) to evaluate preoperative and postoperative function in Peyronies patients undergoing plaque incision and small intestine submucosa (SIS) grafting. METHODS A retrospective chart review was undertaken to identify patients who underwent incision and grafting for Peyronies disease from January 2004 to February 2009. These patients were stratified to include patients who had filled out preoperative and postoperative SHIM and underwent grafting with SIS graft. Patient records were reviewed to obtain demographics, voiding symptoms, preoperative and postoperative SHIM score, American Urological Association Symptom Index, perioperative degree and direction of curvature, perioperative use of phosophodiesterase-5 inhibitors, operative time, length of stay, and complications. RESULTS 25 patients were identified that underwent incision and grafting with SIS graft who had completed both a preoperative and postoperative SHIM questionnaire. Mean patients age at time of surgery was 58.1 years (range 39-78 years). Average length of follow-up after surgery was 6.3 months (range 1-17 months). All patients presented with sign and symptoms of Peyronies disease, with an average duration of symptoms of 38 months (range 9-240 months). Symptoms were stable for an average of 16.5 months (range 6-120 months). Mean degree of curvature was reported at 84.2 degrees (range 70-130 degrees). Preoperative average SHIM score was 11.96 and postoperatively the average SHIM score increased significantly to 16.04 (p = 0.001). 52% of patients preoperatively utilized PDE-5 inhibitors which increased to 73% postoperatively. Postoperative residual curvature was on average 19.8 degrees (range 5-45 degrees), 3 had no curve and another 13 were within physiologically normal limits (≤20 degrees). Preoperatively, 24% were able to have intercourse, while postoperatively 80% reported satisfactory intercourse. Complications included urinary retention (1), urinary tract infection (1), and a residual curve requiring dorsal corpoplasty (1). CONCLUSIONS This data suggests that in patients with adequate preoperative erectile function, SIS grafting is a feasible and effective method for treatment of Peyronies disease associated with improved SHIM scores, satisfactory capacity for intercourse, and minimal morbidity. Nashville, TN© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e475 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Benjamin Whittam More articles by this author Todd Doran More articles by this author Melissa Kaufman More articles by this author Douglas Milam More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Endoscopic Urethroplasty Using Small Intestinal Submucosal Patch in Cases of Recurrent Urethral Stricture: A Preliminary Study

The objective of this study was to evaluate the results of internal urethrotomy with endoscopically placed small intestinal submucosa (SIS) graft for treatment of selected cases of recurrent urethral stricture. This prospective study included 10 patients with recurrent inflammatory bulbar urethral stricture of 0.5-2 cm in length with no dense spongiofibrosis. Following the 12 o'clock visual internal urethrotomy, a prepared 12F Foley's silicon catheter with the SIS patch was introduced into the urethra over a preplaced super-stiff guidewire. The advancement of this catheter was monitored via a 15F urethroscope to enable us to put its balloon with the overlying SIS patch at the site of the urethral incision. Thereafter, the balloon was inflated with saline and the catheter was secured with a silk suture to the glans. In addition, a suprapubic cystostomy was fixed for bladder drainage. These catheters were kept in place for 2 weeks. The patients were followed up at regular intervals using uroflowmetry and ascending urethrography. At 3-month follow-up, only two cases showed mild recurrent stricture and the rest of cases had a normally patent functional urethra. The subsequent follow-up studies of all the eight successful cases for 12-18 months revealed no evidence of recurrent stricture in all of them and no more interventions were required for any of them. On the other hand, the two cases with recurrent stricture showed a satisfactory response to regular monthly urethral dilatation. Endoscopic urethroplasty using SIS patch can be considered as a minimally invasive solution for cases with recurrent, short urethral stricture that are associated with mild spongiofibrosis.

UP-3.121: Long-Term Outcomes after Treatment of Peyronie's Disease by Porcine Small Intestinal Submucosa (SIS) Grafts

UP-3.121: Long-Term Outcomes after Treatment of Peyronie's Disease by Porcine Small Intestinal Submucosa (SIS) Grafts

Use of porcine small intestinal submucosa to reconstruct an ovarian defect

Objective To investigate the feasibility of using porcine small intestinal submucosa (SIS) as a scaffold for repairing ovarian defects. Method Fourteen female New Zealand rabbits undergoing ovarian resection were randomly allocated to 2 equal groups. The unilateral ovarian defects were repaired with SIS in group 1 animals and without SIS in group 2 animals (control). The volumes of the ovaries were calculated and the severity of adhesions was assessed in 1 animal from each group each month. The ovaries were removed and examined under a microscope. Results The volumes of the SIS-grafted ovaries were larger than those of the operated ovaries of the control animals ( P < 0.05). The SIS-grafted ovaries had a lower adhesion score than the operated ovaries of the control group ( P < 0.001). SIS grafts showed hemorrhage and leukocyte infiltration until the 4th week after surgery, but the ovarian tissue appeared to be well organized from the 12th to the 16th week. At the 28th week, primordial follicles were scattered in the SIS graft. Conclusion SIS graft could be used for repairing the ovary after surgery.

Outcomes, Recurrence Rates, and Postoperative Sexual Function After Secondary Vaginal Prolapse Surgery Using the Small Intestinal Submucosa Graft

Outcomes, Recurrence Rates, and Postoperative Sexual Function After Secondary Vaginal Prolapse Surgery Using the Small Intestinal Submucosa Graft

Temporal differentiation and maturation of regenerated rat urothelium

To determine if porcine small intestinal submucosa (SIS)-regenerated urothelium expresses markers of urothelial differentiation, uroplakin and zona occludens-1 (ZO-1), and whether their expression correlates with the histological appearance of the urothelium. In all, 15 rats underwent partial cystectomy and bladder replacement with SIS. Regenerated bladders were harvested at either 2, 7, 14, 28, or 56 days after SIS grafting. Histological examination with haematoxylin and eosin staining was conducted to assess tissue regeneration. Immunohistochemistry was performed with uroplakin and ZO-1 antibodies. By 14 days after SIS grafting, the urothelial layer was completely confluent over the SIS. Expression of uroplakin and ZO-1, evident at 2 days after SIS grafting, progressed from a cytoplasmic pattern of expression to a mature pattern of cytoplasmic and membrane expression by 56 days after SIS grafting. In vivo tissue regeneration produces histologically and phenotypically mature urothelium within 2 weeks of SIS implantation. Regeneration of functional urothelium is probably essential for the subsequent development of the remaining bladder.

Experimental comparison of abdominal wall repair using different methods of enhancement by small intestinal submucosa graft

To assess the biomechanical properties of full-thickness abdominal wall defects, either using Native tissues, with or without Overlay, and by substitution of the Defect by small intestinal submucosa mesh. Seventy-two rats were divided into three groups according to repair method (Native, Overlay or Defect). At 7, 14, 30, and 90 days, six rats were sacrificed to measure tensile strength, collagen ingrowth, and host response. Explants had comparable strength at 30 days, the majority rupturing at the interface. Afterwards, the Native group was more resistant than both small intestine submucosa (SIS) groups with a more organized fibrotic scar on histology at 90 days. SIS augmentation of native tissue repair does not increase strength. Replacement of abdominal wall by SIS is equally strong when compared to the SIS-augmented group; however, materials preferably rupture at the site of the implant itself.

Are Biologic Grafts Effective for Hernia Repair?

Biologic grafts for hernia repair are a relatively new development in the world of surgery. A thorough search of the Medline database for uses of various biologic grafts in hernia shows that the evidence behind their application is plentiful in some areas (ventral, inguinal) and nearly absent in others (parastomal). The assumption that these materials are only suited for contaminated or potentially contaminated surgical fields is not borne out in the literature, with more than 4 times the experience being reported in clean fields and the average success rates being higher (93% vs 87%). Outcomes prove to be highly dependent on material source, processing methods and implant scenarios with failure rates ranging from zero to more than 30%. Small intestinal submucosa (SIS) grafts have an aggregate failure rate of 6.7% at 19 months whereas acellular human dermis (AHD) grafts have a failure rate of 13.6% at 12 months. Chemically cross-linked grafts have much less published data than the non-cross-linked materials. In particular, the search found 33 articles for SIS, 32 for AHD, and 13 for cross-linked porcine dermis. Furthermore, the cumulative level of evidence for each graft material was fairly low (2.6 to 2.9), and only 1 material (SIS) had level 1 evidence reported in any hernia type (inguinal and hiatal). Together, biologic grafts have published evidence showing success rates better than 90% overall and more than 2000 years of cumulative implant time. Improvements in materials, techniques, and patient selection are likely to improve these numbers as this field of surgery matures.

Angiographic Evaluation of Carotid Artery Grafting with Prefabricated Small-Diameter, Small-Intestinal Submucosa Grafts in Sheep

The purpose of this study was to report the longitudinal angiographic evaluation of prefabricated lyophilized small-intestinal submucosa (SIS) grafts placed in ovine carotid arteries and to demonstrate a variety of complications that developed. A total of 24 grafts, 10 cm long and 6 mm in diameter, were placed surgically as interposition grafts. Graft patency at 1 week was evaluated by Doppler ultrasound, and angiography was used for follow-up at 1 month and at 3 to 4 months. A 90% patency rate was found at 1 week, 65% at 1 month, and 30% at 3 to 4 months. On the patent grafts, angiography demonstrated a variety of changes, such as anastomotic stenoses, graft diffuse dilations and dissections, and aneurysm formation. These findings have not been previously demonstrated angiographically by other investigators reporting results with small-diameter vessel grafts made from fresh small-intestinal submucosa (SIS). The complications found were partially related to the graft construction from four SIS layers. Detailed longitudinal angiographic study should become an essential part of any future evaluation of small-vessel SIS grafting.

Intense Inflammatory Reaction With Porcine Small Intestine Submucosa Pubovaginal Sling or Tape for Stress Urinary Incontinence

To report on the intense local inflammatory reactions in patients undergoing pubovaginal sling or tape using a small intestinal submucosa graft. A case series of such inflammatory complications is presented. We performed 16 standard pubovaginal sling or tension-free tape procedures for stress urinary incontinence, using the Cook 4-ply Stratasis or 8-ply Stratasis-TF system. The diagnosis had been confirmed by the history, physical examination, and urodynamic study findings. Of the 16 patients, 5 (31.3%) had intense suprapubic pain after surgery. One patient had induration of the mons pubis that required surgical drainage. Another patient had vaginal inflammation, with expulsion of graft material. Other patients had intense rectus sheath inflammation, as confirmed on computed tomography, that resolved with conservative care. Previous case reports of inflammatory complications of small intestinal submucosa were confirmed in 31% of our patients. We have ceased using this product pending additional investigations or reformulation of the graft material.

Corporeal Grafting for Severe Hypospadias: A Single Institution Experience With 3 Techniques

Correction of severe chordee by corporeal body grafting has been successfully performed using various grafts and biomaterials. We report a single institution comparison of our experience using small intestinal submucosa, tunica vaginalis and dermal grafts at stage 1 hypospadias repair. A retrospective chart review was performed of the records of all patients who underwent staged hypospadias repair from 1985 to 2006 with corporeal body grafting at stage 1 with small intestinal submucosa, tunica vaginalis or dermal grafts. Age at grafting, time between stages, residual chordee at stage 2 repair and the need for additional plication or chordee correction at stage 2 were recorded. A total of 71 patients were identified with a median age of 10 months at stage 1 repair and a median of 7.6 months between stages 1 and 2 repair. Dermal grafts, tunica vaginalis and small intestinal submucosa grafts were used in 29, 21 and 20 patients, respectively. One patient received a combination of small intestinal submucosa and tunica vaginalis. None of the patients receiving tunica vaginalis graft required any further correction of chordee. One patient with a dermal graft and 1 receiving small intestinal submucosa required Nesbit plication at stage 2 repair for minor ventral chordee. One patients receiving small intestinal submucosa showed severe fibrosis at the graft site, requiring excision and repeat grafting with tunica vaginalis. This patient has been previously described. The 2 patients with small intestinal submucosa related complications had 4-ply grafts. We have seen no complications associated with 1-ply small intestinal submucosa. At limited followup we have not seen residual chordee after stage 2 repair. In a large group of children requiring corporeal grafting for severe chordee we observed successful chordee correction with 1-ply small intestinal submucosa, tunica vaginalis or dermal grafts.

Reconstructive cranioplasty using a porcine small intestinal submucosal graft

A six-year-old border collie was presented with a solid mass on the dorsal cranium. Histological examination showed the mass to be a multilobular tumour of bone. A magnetic resonance imaging scan confirmed deformation of the dorsal cranium with compression of the cerebral hemispheres. A craniotomy was performed to excise the mass and overlying skin, resulting in a substantial deficit of calvarium and skin. A cranioplasty using a small intestinal submucosal (SIS) graft was performed to reconstruct the calvarial defect. A local myocutaneous advancement flap was elevated and positioned over the cranioplasty to close the skin deficit. The outcome of this reconstruction was aesthetic and functional. The small intestinal submucosal graft provided satisfactory mechanical support and was a suitable physical barrier in place of the calvarial bone. Histological examination of the small intestinal submucosal graft 128 days after implantation showed that the graft had been replaced by a dense network of collagenous tissue, with small focal areas of partially mineralised woven bone merging with a fibrocartilaginous matrix of the deeper margin. Histological examination also confirmed regrowth of the multilobular tumour of bone in the region of the small intestinal submucosal graft indicating that it is only a suitable implant if adequate surgical margins are obtained.

Small intestinal submucosa for patch grafting after plaque incision in the treatment of Peyronie's disease

Report the results using porcine small intestinal submucosa (SIS) as a graft material in the surgical management of Peyronie's disease (PD). We performed a retrospective chart review of men with PD who underwent surgical correction of the curvature by plaque "H" incision and patch grafting with 4-ply SIS (Cook, Bloomington, IN) by a single surgeon at our institution. Degree and direction of curvature, sexual function, and co-morbidities were assessed pre- and postoperatively. Thirteen patients were identified. Mean age was 57 +/- 8, range 42-70 years. Median follow-up was 14 months, range 3-89 months. At presentation, all reported penile curvature. Also reported were difficulty with vaginal penetration (determined by question number 2 of the sexual encounter profile questionnaire - SEP2), palpable plaque, hourglass deformity, difficulty with firmness, and difficulty with sustaining erection (determined by SEP3) in 77%, 69%, 77%, 62%, and 46% of patients, respectively. Mean and median degrees of curvature of the primary deformity were 71 and 67.5 degrees, respectively. Three patients had secondary curves of less than 30 degrees in a different direction. Mean and median plaque size were 3.5 and 2.7 cm2, respectively. Seven patients had one graft and six patients had two grafts placed with a mean size of 15 +/- 0 cm2. For the patient with PD, SIS grafting can achieve a functionally straight erection with durable results yet with relatively high rates of erectile dysfunction. SIS is a viable graft material for use in the surgical treatment of PD.

Use of Small Intestinal Submucosa Graft for the Surgical Management of Peyronie’s Disease

We report on the long-term followup of porcine small intestinal submucosal graft as a closure material for the tunica albuginea after plaque incision. A total of 162 patients with at least a 12-month history of Peyronie's disease with penile curvature of 60 degrees or more were evaluated. Patient age ranged from 33 to 69 years (mean 52). Preoperatively all patients underwent intracavernous injection and photographic documentation of curvature. Surgisis ES, derived from porcine small intestine, was immersed in normal saline and was used to graft the tunical deficit after plaque incision using a subcoronal incisional approach. Surgical correction of penile curvature was achieved in 148 of 162 patients (91%). At a mean followup of 38 months (range 6 to 96) 79% of the patients were fully potent with 21% requiring assistance. No reports of intraoperative penile shortening, long-term pain, infection, bulging at the graft site or evidence of a local immunogenic rejection reaction have been noted. Surgisis grafts for the coverage of cavernous defects after Peyronie's plaque incision allow for satisfactory clinical results in long-term followup. The ease of surgical handling and placement, no associated comorbidities from harvesting techniques, and no adverse reactions make this material an anatomical and functional tunical substitute.

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.

Safety and efficacy of the porcine small intestinal submucosa dural substitute: results of a prospective multicenter study and literature review

Dural substitutes are often needed after neurosurgical procedures to expand or replace dura mater resected during surgery. A new dural repair material derived from porcine small intestinal submucosa (SIS) was evaluated in a prospective multicenter clinical study. Between 2000 and 2003, 59 patients at five different institutions underwent dural reconstruction with the SIS dural substitute, with a minimum follow up of 6 months. The primary goals of the study were to assess the efficacy and safety of the SIS dural substitute according to the rate of cerebrospinal fluid (CSF) leakage, infection, and meningitis. Chiari malformation Type I decompression (32 patients) and tumor resection (18 patients) were the most common procedures performed, with 81% of SIS grafts implanted in the posterior fossa or spine. There was one case of a CSF leak (1.7%), two cases of wound infection (3.4%), and no cases of bacterial meningitis (0%) in the 58 patients available for follow up. In both cases of wound infection, the SIS graft acted as a barrier to infection and was not removed. Intraoperatively, a watertight seal was achieved in all 59 cases. On follow-up imaging available in 27 patients there was no evidence of any adverse reaction to the graft or of cerebral inflammation. The SIS dural substitute demonstrated substantial efficacy in these patients after a mean follow up of 7.3 +/- 2.2 months. Rates of infection, CSF leakage, and meningitis were comparable to those reported for other dural substitute materials. A lack of adverse reactions to the graft, favorable safety profile, and clinical efficacy all point to the utility of this material as an alternative for dural repair.

Corporal grafting for severe hypospadias - a single institutional experience with three different techniques

Purpose Correction of severe chordee by corporal body grafting has been successfully performed using a variety of grafts and biomaterials. To date there has been no large single institutional experience comparing the various techniques. We report our outcomes comparing small intestinal submucosa (SIS), tunica vaginalis (TV), and dermal grafts (DG) used for correcting chordee at the time of first stage hypospadias repair. Materials and methods A retrospective chart review was conducted including all patients that underwent two stage hypospadias repair from 1985 to 2006 with corporal body grafting at the first stage. Age at time of surgery, residual chordee at the time of the second stage, and the need for additional placation or chordee correction at the second stage was recorded. Results A total of 71 patients were identified, with a median age at initial corporal grafting of 10 months, and median time between first and second stage of 7.6 months. DG were used in 29, TV in 21, and SIS in 20 patients. One patient had both SIS and TV grafts placed. Complications requiring corporal plication at the time of the second stage occurred with one DG and one SIS graft for minor residual ventral chordee. One patient that had 4-ply SIS developed severe fibrosis required graft excision and regrafting with TV. No single layer SIS grafts had complications. No patient has demonstrated residual chordee after second stage hypospadias repair. Conclusions In a large group of children requiring corporal grafting for severe chordee associated with proximal hypospadias we have demonstrated successful outcomes with SIS, tunica vaginalis or dermal grafts with no significant differences in results.