Porcine Small Intestinal Submucosa Graft Research Articles

Efficacy and safety of pelvic organ prolapse surgery with porcine small intestinal submucosa graft implantation

ObjectiveThe ideal implant material for the surgical repair of pelvic organ prolapse in women is yet to be found. This retrospective study aims to evaluate a porcine small intestinal submucosa (SIS) graft (Surgisis™). Study designWe reviewed the medical records of women that were operated upon for pelvic organ prolapse using implantation of SIS graft and we examined the short-term complications and recurrence rates. ResultsA total of 155 surgical procedures were reviewed. SIS graft was placed in the anterior, posterior and middle compartments in 93 (60%), 71 (45.8%) and 13 (8.4%) cases, respectively. At three-month follow-up, 22.6% of anterior graft repairs displayed anatomical recurrence (POP-Q stage ≥ 2), compared to 4.8% of posterior and none of the middle compartment graft repairs. During the three postoperative months, 56% of the women were recorded with complications, mostly urinary retention (19%) and pain (12%). The incidence of grade III complications was 5.3%. Persistent complications at three months were observed in 28% of all cases. Logistic regression analysis showed that previous prolapse surgery at the same compartment was a significant predictor for recurrence of prolapse after SIS graft application, whereas lower age, smoking and longer duration of surgery were significant predictors for the development of complications. Younger women had higher risk of developing pain postoperatively. ConclusionPain and urinary tract symptoms hold a central position in the complications profile of SIS graft-augmented prolapse surgery. The relatively high recurrence rates do not suggest a clear benefit from SIS graft use.

Penile lengthening with porcine small intestinal submucosa grafting in Peyronie's disease treatment: long-term surgical outcomes, patients' satisfaction and dissatisfaction predictors.

Peyronie's Disease (PD) is an acquired connective tissue disorder that often leads to penile curvature (PC) and sexual dysfunction. Penile lengthening procedures (PLP) with four-layered porcine small intestinal submucosa graft (Surgisis® ES; Cook) have been widely used in patients with severe PC when erectile function is preserved. However, complications such as erectile dysfunction (ED) may limit treatment satisfaction. Focusing on patients perspective, our study aims to evaluate longterm patient-reported outcomes, satisfaction, and dissatisfaction predictors after PLP. This prospective study included 32 patients affected by PD with severe PC submitted to PLP with Surgisis® ES between 2011 and 2014. All patients were submitted to a standardized protocol with regular clinical evaluation at 3, 6 and 12months, and yearly thereafter. After the third year follow-up, IIEF-5, modified EDITS and an additional non-validated questionnaire were completed. Concerning the surgical procedure, the mean tunical defect area (TDA) was 15.9±6.9cm2 . The mean follow-up time were 49.6±12.7months and there was a significant increase in stretched penile length (p=0.01). Postoperative erectile function as assessed by IIEF-5 was positively correlated with overall treatment satisfaction evaluated through EDITS (p=0.01). TDA was negatively correlated with postoperative IIEF-5 (R=-0.56, p<0.001). TDA ≥ 14.375cm2 can predict ED with 76.9% sensibility and 58.3% specificity. Moreover, TDA ≥ 21.875cm2 can predict clinically significant ED (IIEF-5 score ≤17) with 80% sensibility and 95.2% specificity. Patient-reported longterm complications were 65.6% decreased penile length, 56.5% diminished rigidity and 25% curvature recurrence. PLP using a Surgisis® ES is a valuable surgical option for the treatment of PD with severe PC. Although it results in high rates of long-term patient-reported overall satisfaction, possible outcomes such as postoperative ED must be acknowledged. TDA is a strong predictor for postoperative ED and should be considered in clinical practice to classify patients in low- or high-risk for postoperative ED.

494 Penile lengthening with porcine small intestinal submucosa grafting in Peyronie’s disease treatment: long-term surgical outcomes, patients satisfaction and dissatisfaction predictors.

Peyronie’s Disease (PD) is an acquired connective tissue disorder that often leads to penile curvature (PC) and sexual dysfunction. Penile lengthening procedures (PLP) with four-layered porcine small intestinal submucosa graft (Surgisis®ES; Cook, USA) have been widely used in patients with severe PC when erectile function is preserved. However, complications such as erectile dysfunction (ED) may limit treatment satisfaction. Focusing on patients perspective, our study aims to evaluate longterm patient-reported outcomes, satisfaction, and dissatisfaction predictors after PLP. This prospective study included 32 patients affected by PD with severe PC submitted to PLP with Surgisis®ES between 2011 and 2014. All patients were submitted to a standardized protocol with regular clinical evaluation at 3, 6 and 12 months, and yearly thereafter. After the third year follow-up, IIEF-5, modified EDITS and an additional non-validated questionnaire were completed. Concerning the surgical procedure, the mean tunical defect area (TDA) was 15.9±6.9cm2. The mean follow-up time were 49.6±12.7 months and there was a significant increase in stretched penile length (p=0.01). Postoperative erectile function as assessed by IIEF-5 was positively correlated with overall treatment satisfaction evaluated through EDITS (p=0.01). TDA was negatively correlated with postoperative IIEF-5 (R=-0.56, p<0.001). TDA ≥ 14.375cm2 can predict ED with 76.9% sensibility and 58.3% specificity. Moreover, TDA ≥ 21.875 cm2 can predict clinically significant ED (IIEF-5 score ≤17) with 80% sensibility and 95.2% specificity. Patient-reported longterm complications were 65.6% decreased penile length, 56.5% diminished rigidity and 25% curvature recurrence.

Surgical treatment of Peyronie’s disease with small intestinal submucosa graft patch

The objective of the study was to report our results using a porcine small intestinal submucosa graft (Surgisis ES, Cook Medical) for tunica albuginea substitution after plaque incision. We retrospectively evaluated patients surgically treated at our institution for Peyronie's disease (PD) by means of plaque incision and porcine small intestinal submucosa grafting (Surgisis) between 2009 and 2013. At the same time a literature review was conducted, searching for similar reports and results. Forty-four patients were identified who had been diagnosed with PD between 2009 and the beginning of 2013, and had been treated with corporoplasty, plaque incision and grafting with Surgisis for a severe curvature of the penis. Curvature of the penis was dorsal in 40 patients (90%) and laterally on the right in 4 patients (10%). Mean duration of surgery was 165 min (range 90-200). Mean size of the graft was 6.5 cm(2) and the mean follow-up was 19.2 months (range 11-48). In patients with severe curvature of the penis due to PD and the need for corporoplasty with plaque incision and graft placement, Surgisis represents a good option with a low risk of complications, below the rate described with previously investigated graft tissues.

Excision and Patch Grafting of a Lateral Peyronie's Plaque-Utilizing a Longitudinal "Window" Approach.

IntroductionPeyronie’s disease (PD) is a debilitating disorder in which collagen deposition, fibrosis, and plaques in the tunica albuginea result in penile curvature, shortening, and pain. For severe curvatures requiring plaque incision or excision with grafting (PIEG), a subcoronal circumcising incision with penile degloving has historically been used.AimsThe aim of this study was to report our unique approach to PIEG via a longitudinal “window” incision for the correction of PD, minimizing the surgical manipulation and dissection accompanying the traditional circumcising incisional approach that may lead to increased postoperative edema, pain, and prolonged healing time.MethodsA patient presented with a stable, painless, 90-degree midshaft leftward curvature causing penetration difficulties and painful intercourse for his partner. His Sexual Health Inventory for Men (SHIM) score was 23. The patient opted for surgical correction with plaque excision and grafting via a 4-cm longitudinal incision overlying the point of maximal curvature along the left lateral penile shaft. This direct access to the left corpus cavernosum and plaque, along with dissecting skin, dartos, and Buck’s fascia, created a window with sufficient exposure for excision and patch grafting.Main Outcome MeasuresThe main outcome measures were objective data and subjective data in men undergoing PIEG via lateral longitudinal “window” incision for PD repair.ResultsThe plaque was excised and a porcine small intestinal submucosa graft was sewn in. Intraoperative artificial tumescence at the end of surgery revealed complete correction of the curvature. The patient experienced painless rigid erections by postoperative day three with minimal penile edema. By postoperative week four, he could successfully partake in coitus. His SHIM score remained unchanged. At maximum follow-up 6 months postoperatively, he still endorsed excellent cosmetic and functional outcomes with spontaneous unassisted erections and no recurrence of his curvature.ConclusionA lateral longitudinal incision for PIEG is a feasible technique and may reduce the postoperative morbidity and dissection required with traditional circumcising incision with penile degloving. Larger comparative studies are necessary for further evaluation.

Acellular porcine small intestinal submucosa graft for cervicovaginal reconstruction in eight patients with malformation of the uterine cervix

Can surgical reconstruction of the cervix and vagina in patients be achieved using an acellular porcine small intestinal submucosa (SIS) graft? Our experiences of combined laparoscopic and vaginal cervicovaginal reconstruction using an SIS graft in eight patients were positive, with successful reconstruction and no complications, cervical stenosis or vaginal stenosis. In patients with agenesis and dysgenesis of the uterine cervix and vagina, surgical reconstruction of the internal genitalia is a challenging problem for gynecologists. Hysterectomy with the creation of an artificial vagina was the treatment of choice in the 1990s. Recently, conservative management has been gradually adopted to avoid extirpation of the uterus, including the canalization techniques, the uterovaginal anastomosis and the reconstruction of cervical and vaginal agenesis with some autologous tissues. This prospective observational study from January 2012 to March 2013 included 8 patients aged 10-18 years with malformation of the cervix (1 with cervical agenesis, 1 with a cervical body consisting of a fibrous band and 6 with obstruction of the cervical os) and vagina (4 with complete vaginal aplasia and 4 with a 1-3 cm long vaginal pouch) diagnosed by physical examination and magnetic resonance imaging. Eight patients underwent combined laparoscopic and vaginal cervicovaginal reconstruction using an SIS graft during the end of menstruation. A T-shaped intrauterine device connected with a 14-French Foley catheter was inserted into the uterine cavity to keep the newly created cervix patent, and then a permanent lower uterine cerclage was placed. Patients were assessed post-operatively at 1, 2, 4, 6, 12 and 15 months, and data on menstruation and the morphology of the neovagina and cervix were recorded. The mean ± SD age of the patients was 14.5 ± 2.8 (10-18) years. All patients had a history of cyclic abdominal pain, and the average delay in diagnosis was 4.5 ± 4.0 (0-12) months. One patient had a previous history of unsuccessful attempt at canalization and two post-operative hematometra drainages before referral. The mean operating time was 201 ± 67 (120-330) min, with a mean estimated blood loss of 157 ± 154 (30-500) ml. The first case was converted to laparotomy, and the others were successfully completed. None of the patients had a complication or required blood transfusion. All the patients showed resumption of menstruation. The patients were followed for 8 ± 4 (4-15) months, and no cervical or vaginal stenosis occurred in any of the cases. The sample size of this study was small. A larger study that compared this method with previous techniques regarding the complication and success rates would increase the value of the study. A combined laparoscopic and vaginal cervicovaginal reconstruction with an SIS graft is a potential alternative to the management of congenital agenesis and dysgenesis of uterine cervix and vagina. The work was supported by National Key Clinical Faculty Construction Program of China. No competing interests are declared.

Laparoscopic–Assisted Uterovaginal Anastomosis for Uterine Cervix Atresia With Vaginal Aplasia Using a Silicone Stent Lined With Acellular Porcine Small Intestinal Submucosa Graft Inserted Using a 16F Foley Catheter

Herein is reported a novel technique for cervical reconstruction of congenital cervicovaginal atresia. The patient was a 16-year-old girl with congenital atresia of the cervix and vagina, didelphic uterus, and right hematosalpinx. At laparoscopic-assisted creation of a neocervix, a silicone stent was inserted using a 16F Foley catheter and lined with an acellular porcine small intestinal submucosa graft under ultrasound guidance. At 3-month clinical follow-up after placement of the stent, the patient had regular menstrual flow. The neocervix was completely mucosalized on the inner surface at 4 months after surgery. There were no complications related to the silicone stent or the cervical stent. Cervical reconstruction using a vaginal mucosa–lined silicone stent is accessible and effective, and provides an alternative option to preserve reproductive potential in patients with cervicovaginal atresia.

Rectocele repair: A randomized trial of three surgical techniques including graft augmentation

This study was undertaken to compare outcomes of 3 different rectocele repair techniques. One hundred six women with stage II or greater posterior vaginal wall prolapse were randomly assigned to either posterior colporrhaphy (n = 37), site-specific rectocele repair (n = 37), or site-specific rectocele repair augmented with a porcine small intestinal submucosa graft (Fortagen, Organogenesis, Inc, Canton, MA; n = 32). Subjects underwent a physical examination and completed 3 validated pelvic floor instruments at baseline and 6 months, 1 year, and 2 years after surgery. Anatomic failure was defined as pelvic organ prolapse quantitation system (POPQ) point Bp > or = -2 at 1 year. Of 106 subjects who enrolled, 105 underwent surgery and of those 105, 98 subjects returned (93%) with a mean follow-up of 17.5 +/- 7 months. After 1 year, those subjects who received graft augmentation had a significantly greater anatomic failure rate (12/26; 46%) than those who received site-specific repair alone (6/27; 22%) or posterior colporraphy (4/28; 14%), P = .02. There was a significant improvement in prolapse and colorectal scales and overall summary scores of the Pelvic Floor Distress Inventory short form 20 (PFDI-20), the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7) after surgery in all groups (P < .001 for each) with no differences between groups. The proportion of subjects with functional failures was 15% overall, and not significantly different between groups. There was no significant change in the rate of dyspareunia 1 year after surgery and there were no differences between groups. Overall sexual function as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12) improved significantly in all groups postoperatively (P < . 001), with no differences between groups. Posterior colporraphy and site-specific rectocele repair result in similar anatomic and functional outcomes. The addition of a porcine-derived graft does not improve anatomic outcomes. All 3 methods of rectocele repair result in significant improvements in symptoms, quality of life, and sexual function.

Ureteral Segment Replacement Using a Circumferential Small-Intestinal Submucosa Xenogenic Graft

ABSTRACT We wished to determine whether small-intestinal submucosa (SIS) will epithelialize when used as a ureteral replacement material. An 11-mm segment of native ureter was excised from eight New Zealand White rabbits and replaced with an 11-mm porcine SIS graft, which was circumferentially wrapped around a ureteral stent. The SIS ureteral grafts were harvested at 11 days or 35 days postimplantation and examined grossly and by standard light microscopy techniques. Partial epithelialization with the ingrowth of urothelium, smooth muscle cells, and blood vessels was observed in the grafts harvested at 11 days postimplantation. The SIS ureteral grafts examined at 35 days postimplantation showed additional restructuring of the smooth muscle cell layer and more organized epithelialization in comparison to the SIS graft examined at 11 days. After 35 days of regenerative healing, elements of all three layers of the native ureter were observed within the collagen matrix of the SIS graft. No significant complications were observed, but all subjects (8/8) demonstrated mild intra-abdominal adhesions. Mild collecting system dilatations were observed in 4/4 (100%) of the animals harvested at 35 days and in 0/4 (0%) of the animals harvested at 11 days. We have this demonstrated in this preliminary study that SIS xenografts will epithelialize when used as a ureteral replacement material. The repair mechanism of these ureteral grafts occurred through a regenerative healing process rather than by scar formation. With further studies, this material may prove to be a useful treatment option in patients with ureteral injuries.