Treatment of fecal incontinence-is there a light in the end of the tunnel?

Fecal incontinence (FI) is a common disease with higher incidence rates in the elderly population. Treatment of affected patients remains challenging and ranges from conservative management to surgical techniques. Despite all efforts patients often undergo several therapeutic measurements to achieve reasonable functional improvements.Although sacral neuromodulation still remains a key therapy with success rates up to 80%, a significant number of patients do not respond sufficiently and require further treatment.Several artificial bowel sphincter devices exist, which can lead to better functional control in selected patients. Notably, complications after these surgeries do occur frequently and the need for implant replacement is still considerable high.A novel anal band, developed by Agency for Medical Innovations (A.M.I., Austria) is currently under evaluation. This device, composed of silicone and polyester, is placed around the anus outside the external sphincter muscle complex aiming to improve stool continence via mechanical pressure. Early results of this new operation are eagerly awaited.

Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago.

BACKGROUND: Literature suggests colonic resection and primary anastomosis (RPA) instead of Hartmann's procedure (HP) for the treatment of left-sided colonic emergencies. We aim to evaluate the surgical options globally used to treat patients with acute left-sided colonic emergencies and the factors that leading to the choice of treatment, comparing HP and RPA. METHODS: This is a prospective, international, multicenter, observational study registered on ClinicalTrials.gov. A total 1215 patients with left-sided colonic emergencies who required surgery were included from 204 centers during the period of March 1, 2020, to May 31, 2020. with a 1-year follow-up. RESULTS: 564 patients (43.1%) were females. The mean age was 65.9 ± 15.6 years. HP was performed in 697 (57.3%) patients and RPA in 384 (31.6%) cases. Complicated acute diverticulitis was the most common cause of left-sided colonic emergencies (40.2%), followed by colorectal malignancy (36.6%). Severe complications (Clavien-Dindo ≥ 3b) were higher in the HP group (P < 0.001). 30-day mortality was higher in HP patients (13.7%), especially in case of bowel perforation and diffused peritonitis. 1-year follow-up showed no differences on ostomy reversal rate between HP and RPA. (P = 0.127). A backward likelihood logistic regression model showed that RPA was preferred in younger patients, having low ASA score (≤ 3), in case of large bowel obstruction, absence of colonic ischemia, longer time from admission to surgery, operating early at the day working hours, by a surgeon who performed more than 50 colorectal resections. CONCLUSIONS: After 100 years since the first Hartmann's procedure, HP remains the most common treatment for left-sided colorectal emergencies. Treatment's choice depends on patient characteristics, the time of surgery and the experience of the surgeon. RPA should be considered as the gold standard for surgery, with HP being an exception.

Cost-effectiveness of teduglutide in adult patients with short bowel syndrome - a European socioeconomic perspective.

BACKGROUND: Short bowel syndrome with intestinal failure (SBS-IF) is a rare but devastating medical condition. An absolute loss of bowel length forces the patients into parenteral support dependency and a variety of medical sequelae, resulting in increased morbidity and mortality. Interdisciplinary treatment may include therapy with the effective but expensive intestinotrophic peptide teduglutide. OBJECTIVES: A time-discrete Markov model was developed to simulate the treatment effect [lifetime costs, quality-adjusted life years (QALYs), and life years (LYs)] of teduglutide plus best supportive care compared with best supportive care alone in patients with SBS-IF. METHODS: The health status of the model was structured around the number of days on PS. Clinical data from 3 data sets were used: 1) an Austrian observational study (base case), 2) pooled observational cohort studies, and 3) a prospective study of teduglutide effectiveness in parenteral nutrition-dependent short bowel syndrome subjects. Direct and indirect costs were derived from published sources. QALYs, LYs, and costs were discounted (3% per annum). RESULTS: Under the base case assumption, teduglutide is associated with costs of 2,296,311 € per patient and 10.78 QALYs (13.74 LYs) over a lifetime horizon. No teduglutide is associated with 1,236,816 € and 2.24 QALYs (8.57 LYs). The incremental cost-utility ratio (ICUR) amounts to 123,945 €. In case of the pooled clinical data set, the ICUR increases to 184,961 €. If clinical data based on the study of teduglutide effectiveness in parenteral nutrition-dependent short bowel syndrome subjects were used, the ICUR increased to 235,612 €. CONCLUSIONS: Teduglutide in treating patients with SBS-IF meets the traditional cost-effectiveness criteria from a European societal perspective. Nevertheless, the varying concentrations of teduglutide efficacy leave a degree of uncertainty in the calculations.

Endosonographic monitoring of Sphinkeeper® prostheses movements: does physical activity have an impact?

The Sphinkeeper® procedure for treating faecal incontinence (FI) may be associated with potential implant migration (IM) and dislocation (ID), with considerable variations regarding their occurrence and effects on consecutive functional outcome. This study assessed IM and ID following the Sphinkeeper® procedure and its correlation with physical activity. This was a prospective observational clinical study of ten patients undergoing Sphinkeeper® operation due to FI between August 2020 and November 2020 at the Medical University of Vienna. Patients were followed-up after 1, 2, 3 and 6 months and 1 year postoperatively. Each follow-up visit included endosonographic monitoring of protheses location and manometric examinations. Additionally, functional outcome and physical activity were assessed using validated standardized questionnaires. The median number of prostheses implanted was 10 (IQR 9-10). The St. Mark's incontinence (SMS) score improved significantly until the last follow-up (p = 0.049), without observing a significant effect on the physical SF-12 score. The median rate of implants leading to IM and ID was 3 (range 1-4) and 2 (range 1-2) after 3 months of follow-up. A strong association of deltaSMS with number of dislocated prostheses at one month after Sphinkeeper® implantation was observed (r = 0.654, p = 0.078). Physical activity, assessed by the international physical activity questionnaire, did not have an impact on the correct prosthesis placement (1 month: p = 0.527; 2 months: p = 0.886; 3 months: p = 0.180; 6 months: p = 0.111). IM and ID of Sphinkeeper® prostheses occurred frequently early after surgery and affected functional outcome negatively. Physical activity did not have an influence on the implants displacement.

Long-term outcome after SphinKeeper® surgery for treating fecal incontinence-who are good candidates?

PURPOSE: The efficacy of the novel SphinKeeper® procedure for the treatment of fecal incontinence (FI) is not yet well defined. This study aimed to assess long-term functional outcomes after SphinKeeper® surgery. METHODS: We included 32 patients with FI (28 female), who were operated at a tertiary referral center between August 2018 and September 2021. Functional outcome and quality of life were evaluated prospectively using validated questionnaires before and after surgery. Additionally, endoanal ultrasound and anal manometry were conducted prior and after SphinKeeper® implantation. Predictive parameters for treatment success were defined. RESULTS: The mean follow-up time was 22.62 ± 8.82 months. The St. Mark's incontinence score decreased significantly after surgery (median preoperative = 19 (IQR 17-22) versus median last follow-up = 12 (IQR 8-16), p = 0.001). Similarly, physical short-form health survey showed a significant improvement after SphinKeeper® implantation (p = 0.011). Patients with a higher degree of internal sphincter defect showed an improved objective therapy success (r = 0.633, p = 0.015) after SphinKeeper® operation, whereas the type and severity of FI had no impact on the functional outcome. Notably, a higher number of dislocated prostheses (r = 0.772, p = 0.015) showed a significant correlation with reduced improvement of incontinence. CONCLUSION: The SphinKeeper® procedure showed a significant long-term functional improvement in over half of the patients. Patients with a higher internal sphincter defect benefited most, whereas dislocation of the prostheses was associated with less favorable results.

Surgical Technique for Sphinkeeper® Implantation.

Fecal incontinence is a distressing condition characterized by the involuntary loss of solid and liquid stool and gas, It affects a significant proportion of the general population, with a reported prevalence ranging from 1% to 20%. Despite its considerable impact on quality of life, therapeutic options for fecal incontinence remain limited. Current treatment modalities for fecal incontinence include conservative approaches such as dietary modifications, pelvic floor exercises, and pharmacotherapy. Surgical interventions, including sphincteroplasty or sacral nerve stimulation, may be considered in more severe cases. Recently, THD Labs (THD S.p.A. Correggio (RE), Italy) introduced the Gatekeeper® as a novel device that supports the implantation of up to four solid prostheses into the intersphincteric groove. Early data were promising, with success rates above 50% and only a few perioperative complications. Subsequently, Gatekeeper® was modified by increasing the length and number (up to 10) of prostheses, and renamed Sphinkeeper® (THD). With this device, nine to 10 small incisions measuring 2 mm are made at a distance of 2-3 cm from the anus. The intersphincteric space is accessed using the delivery system, and positioning is verified through endoanal ultrasound. This procedure is repeated for all 10 prostheses placed around the entire circumference. The Sphinkeeper® offers the potential to improve the management of fecal incontinence, and offers patients a less-invasive alternative to traditional surgical approaches.

Efficacy of cx601 (darvadstrocel) for the treatment of perianal fistulizing Crohn's disease-A prospective nationwide multicenter cohort study.

BACKGROUND: The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease; however, data on its clinical application remain scarce. This multicenter nationwide study aimed to assess the clinical efficacy of mesenchymal stem cells in closing complex anal fistulas. METHODS: In this study 14 Crohn's disease patients (3 males, 11 females) with complex anal fistulas treated in 3 tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601-darvadstrocel) was performed in each patient. Closure of the external fistula opening without secretion by external manual compression was defined as treatment success. RESULTS: The median age of the patient population at the time of surgery was 32 years (range 26-53 years) with a median body mass index of 21.7 kg/m2 (range 16.7-26.6 kg/m2). Of the patients 12 (86%) received monoclonal antibodies (infliximab, adalimumab, ustekinumab, vedolizumab) at the time of surgery. The median number of complex fistulas was 1.4 (range 1-2), The median operative time was 20 min (range 6-50 min) with no perioperative complications. After a median follow-up of 92 weeks, we found successful fistula closure in 57.1% (n = 8) of treated patients. The perianal disease activity index did not improve significantly from initially 7 to a median of 6 after 52 weeks (p = 0.495). CONCLUSION: Darvadstrocel is a safe, minimally invasive surgical technique without significant perioperative complications. Clinical success can be expected in about half of the treated patients.

Teduglutide in amyloidosis-associated intestinal failure.

Amyloidosis is a heterogeneous disease characterized by tissue deposition of abnormally folded fibrillary proteins that can manifest itself by a wide variety of symptoms depending on the affected organs. GI involvement among amyloidosis patients is common. Its clinical manifestation often presents with nonspecific symptoms such as weight loss, diarrhea, and malabsorption. With no specific treatment existing for GI amyloidosis, therapy focuses on impeding amyloid deposition and managing the patients' symptoms with supportive measures. Here, we present an AL-amyloidosis patient with GI involvement and intestinal failure (IF) who was successfully treated with the glucagon-like peptide-2 (GLP-2) analogue teduglutide. Over the course of treatment with teduglutide, the patient was able to achieve independence from parenteral nutrition and experienced a significant improvement in quality of life (QoL) as stool frequency and consistency improved, urinary output was stabilized and body weight as well as body composition improved over the course of teduglutide therapy. With no longer being exposed to the burden and associated risks of parenteral nutrition, we were able to reduce the potential morbidity and mortality rate as well as to improve the patient's overall QoL. Intestinal tissue biopsy workup revealed a histopathological correlate for the clinical response; Congo-Red-positive intestinal depositions almost completely disappeared within 6 months of teduglutide therapy. Implementing intestinotrophic GLP-2 analogue teduglutide may enrich the spectrum of treatment options for amyloidosis patients with IF who are dependent on parenteral support.

Standardization of rectal cancer surgery and bowel preparation in Austria : A multicenter nationwide survey by the Austrian Society of Surgical Oncology.

BACKGROUND: Standardized management of colorectal cancer is crucial for achieving an optimal clinical and oncological outcome. The present nationwide survey was designed to provide data about the surgical management of rectal cancer patients. In addition, we evaluated the standard approach for bowel preparation in all centers in Austria performing elective colorectal surgery. METHODS: The Austrian Society of Surgical Oncology (ACO["Arbeitsgemeinschaft für chirurgische Onkonlogie"]-ASSO) conducted a multicenter questionnaire-based study comprising 64 hospitals between October 2020 and March 2021. RESULTS: The median number of low anterior resections performed annually per department was 20 (range 0-73). The highest number was found in Vienna, with a median of 27 operations, whereas Vorarlberg was the state with the lowest median number of 13 resections per year. The laparoscopic approach was the standard technique in 46 (72%) departments, followed by the open approach in 30 (47%), transanal total mesorectal excision (TaTME) in 10 (16%) and robotic surgery in 6 hospitals (9%). Out of 64 hospitals 51 (80%) named a standard for bowel preparation before colorectal resections. No preparation was commonly used for the right colon (33%). CONCLUSION: Considering the low number of low anterior resections performed in each hospital per year in Austria, defined centers for rectal cancer surgery are still scarce. Many hospitals did not transfer recommended bowel preparation guidelines into clinical practice.

Fistula-Associated Anal Adenocarcinoma: A 20-Year Single-Center Experience.

BACKGROUND: Fistula-associated anal adenocarcinoma (FAAC) is a rare consequence in patients with long-standing perianal fistulas. A paucity of data are available for this patient collective, making clinical characterization and management of this disease difficult. OBJECTIVE: This study aimed to describe a single-center experience with FAAC patients, their clinical course, and histopathological and molecular pathological characterization. METHODS: All patients receiving surgery for an anal fistula in 1999-2019 at a tertiary university referral hospital were included in this retrospective analysis. Patients with FAAC were eligible for histopathological analysis, including immunohistochemistry and molecular profiling. RESULTS: This study included 1004 patients receiving surgical treatment for an anal fistula, of whom 242 had an underlying inflammatory bowel disease (IBD). Ten patients were diagnosed with a fistula-associated anal carcinoma (1.0%), and six of these patients had an FAAC (0.6%). The mean overall survival of FAAC patients was 24 ± 3 months. FAAC immunohistochemistry revealed positive staining for CK20, CDX2 and MUC2, while stainings for CK5/6 and CK7 were negative. All FAAC specimens revealed microsatellite stability. Molecular profiling detected mutations in 35 genes, with the most frequent mutations being TP53, NOTCH1, NOTCH3, ATM, PIK3R1 and SMAD4. CONCLUSION: FAAC is rare but associated with poor clinical outcome. Tissue acquisition is crucial for early diagnosis and therapy and should be performed in long-standing, non-healing, IBD-associated fistulas in particular. The immunophenotype of FAAC seems more similar to the rectal-type mucosa than the anal glands.

Technical and functional outcome after sacral neuromodulation using the "H" technique.

BACKGROUND: Sacral neuromodulation (SNM) is a widely accepted treatment for pelvic floor disorders, including constipation and fecal incontinence (FI). In 2017, a standardized electrode placement method, the H technique, was introduced to minimize failure rates and improve clinical outcomes. We aimed to investigate the technical feasibility and functional outcome of the procedure. METHODS: In this prospective study, we evaluated the first 50 patients who underwent SNM according to the H technique between 2017 and 2020 at a tertiary care hospital. Patient demographic and clinical data were collected, and the impact of various factors on patients' postoperative quality of life (QoL) was assessed after a follow-up of 40 months. Functional outcome was monitored prospectively using a standardized questionnaire. RESULTS: Of 50 patients, 36 (72%) reported greater than 50% symptom relief and received a permanent implant (95% CI: 58.3-82.5). We observed 75% success in relieving FI (95% CI: 58.9-86.3) and 64% in constipation (95% CI: 38.8-83.7). Complication occurred in five (10%) patients. Preoperative vs. postoperative physical and psychological QoL, Vaizey score, and obstructed defecation syndrome (ODS) scores revealed significant improvements (all p < 0.01). Male gender was significantly associated with postoperative complications (p = 0.035). CONCLUSION: We provide evidence for the technical feasibility and efficacy of the SNM implantation using the H technique. The medium-term results are promising for patients with FI and constipation. Male patients and those with a BMI > 25 are more prone to perioperative complications.

Teduglutide in short bowel syndrome patients: A way back to normal life?

BACKGROUND: The glucagon-like peptide 2 analogue teduglutide is an effective drug for the treatment of short bowel syndrome patients with intestinal failure (SBS-IF). This intestinotrophic peptide improves intestinal capacity for fluid and nutrient absorption through induction of mucosal growth and reduction of gastrointestinal motility. Clinical trials demonstrated the efficacy of teduglutide in reducing the need for parenteral support (PS). This study describes an SBS-IF patient population receiving teduglutide therapy in a specialized medical care setting. METHOD: A retrospective analysis was performed using data of patients experiencing nonmalignant SBS-IF. They were treated with teduglutide in a multidisciplinary SBS-IF program at a single university medical center between June 2016 and June 2020. RESULTS: Thirteen patients under teduglutide treatment were included in the final analysis. Mean small bowel length was 82 ± 31 cm, with 77% of patients having their colon in continuity. Over a median follow-up of 107 weeks, all patients (13 of 13, 100%) responded to the therapy with a clinically significant reduction of PS volume. Mean PS reduction increased with therapy duration and ranged from -82.5% at week 24 (n = 13) to -100% in patients (n = 5) who were treated for 144 weeks. Enteral autonomy was achieved in 12 of 13 (92%) patients. Teduglutide therapy improved stool frequency and consistency, changed dietary habits, and reduced disease-associated sleep disruptions. CONCLUSION: Integrating SBS-IF patients treated with teduglutide in a proactive and tight-meshed patient care program significantly improves the clinical outcome, leading to an increased proportion of patients reaching enteral autonomy.

Sphinkeeper Procedure for Treating Severe Faecal Incontinence-A Prospective Cohort Study.

(1) Background: The Sphinkeeper implantation for faecal incontinence (FI) is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper surgery in patients with refractory FI. (2) Methods: Between 2018 and 2020, eleven consecutive patients (9 female) with FI met the inclusion criteria and were enrolled for surgery. Functional outcome and quality of life were evaluated by standard questionnaires pre- and post-surgery. Migration of protheses was demonstrated by 3D endoanal ultrasound. The median follow-up time was eight months (range 3-18 months). (3) Results: The median age was 75 years (range 46-89 years) with a median BMI of 27.4 (range 21.2-30.1). The median number of implanted prostheses per intervention was nine (range 9-10). We found no intraoperative or early postoperative complications. After two months, two prostheses in one patient had to be removed due to pain at the perianal skin site. The median St. Mark's incontinence score decreased significantly from 22 to 13 points (p = 0.008). The SF-12 showed a significant improvement (35.9 versus 46.3) after surgery (p = 0.028). A migration of at least one prosthesis was observed in ten patients (91%). Six (60%) prostheses were found at the same level in another ten patients. (4) Conclusion: Sphinkeeper implantation is a promising surgical technique for patients with severe FI. The complication rate is low, and short-term functional improvement can be achieved even in severe forms of FI. Migration of implants commonly occurs.

Long-term outcome in pediatric surgical bypass grafting after traumatic injury and tumor resection: retrospective cohort analysis.

Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery. Besides technical challenges to reconstruct the small and spastic vessels, another concern in bypass grafting is the adequate limb length growth over time. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development. In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at our department between 2002 and 2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years. During the observation period, 33 pediatric patients underwent vascular repair, whereby 15 patients underwent bypass grafting. Median overall follow-up was 4.7 years (IQR ± 9). 8 patients (53%) had a traumatic injury (traumatic surgery group) and 7 patients had a planned orthopedic tumor resection (orthopedic surgery group). In 13/15 (87%) a great saphenous vein (GSV) graft and in 2/15 (13%) a Gore-Tex graft was used for bypassing. Both Gore-Tex grafts showed complete occlusion 12 and 16 years after implantation. No patient died in the early postoperative phase (< 30 days), however 3/7 (43%) in the orthopedic group died during follow-up. Revision surgery had to be performed in 1/15 (7%) patients. A functional use of the extremity was reported in all patients. Normal limb length growth according to the contralateral site, and therefore bypass growth, could be documented in 14/15 patients. Children are surgically challenging. In our study, surgery by a specialized vascular surgery team using GSV grafts led to adequate limb length and bypass growth, and we observed no functional restrictions.

Short-term outcome after ventral hernia repair using self-gripping mesh in sublay technique - A retrospective cohort analysis.

BACKGROUND: Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates. Self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning. However, real-life data on the safe use in that specific indication are still lacking. The purpose of this study is the evaluation of short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair. MATERIALS AND METHODS: This retrospective analysis assessed patients undergoing ventral hernia repair in sublay technique between January 2011 and July 2018 at the Department of Surgery, Medical University of Vienna. 244 consecutive patients were eligible for final analysis. Patients were grouped according to the utilized mesh. Baseline characteristics and peri-as well as postoperative outcome was assessed. RESULTS: There was no significant difference in baseline characteristics between the two groups. Median follow-up was 11 months (IQR 3-30). The overall complication rate (28.3% versus 13.7%, p = 0.005) due to an increased rate of seromas (17.3% versus 6.8%, p = 0.013) and surgical site infections (12.6% versus 4.3%, p = 0.021) was significantly higher in patients with a self-gripping mesh. Significantly more patients with a self-gripping mesh needed a surgical intervention (21.3% versus 9.4%, p = 0.011). CONCLUSION: In sublay ventral hernia repair, the use of self-gripping meshes is associated with a higher overall complication rate and an increased rate of complication-associated surgical interventions when compared to non-self-gripping mesh placements.