Obstructed defaecation syndrome: European consensus guidelines on the surgical management.

Clinical decision-making in the treatment of patients with obstructed defaecation remains controversial and no international guidelines have been provided so far. This study reports a consensus among European opinion leaders on the management of obstructed defaecation in different possible clinical scenarios.

[Rectal bleeding: easy to overcome or still a challenge in proctology?] / Rektale Blutungen: leicht zu beherrschen oder doch eine Herausforderung in der Proktologie?

Rectal bleeding is a frequent symptom in proctology. In most cases frequent causes, such as anal fissures and hemorrhoidal disease can be diagnosed and treated using a structured patient history and basic proctological diagnostic assessment; however, it is not uncommon for proctitis to be the reason for rectal bleeding, which necessitates interdisciplinary diagnostics and treatment. In addition to proctitis associated with chronic inflammatory bowel disease, prolapse-induced, radiogenic, ischemic, infectious types and proctitis associated with sexually transmitted diseases represent important differential diagnoses. Moreover, rectal cancer has to be excluded as the cause of rectal bleeding. Finally, with appropriate diligence most causes of rectal bleeding can be securely identified and effectively managed; however, special circumstances can necessitate interdisciplinary diagnostics and management, including conservative, topical, interventional and surgical treatment options.

[Quality indicators in the treatment of anal fistulas]. / Qualitätsindikatoren bei der Therapie der Analfisteln.

Anal fistulas are a common anorectal disease and are frequently associated with a perianal abscess. The etiology is based on a cryptoglandular infection in the intersphincteric space. Surgery remains the only definitive therapy. The primary goal of definitive fistula surgery is healing; however, success of fistula surgery is influenced by a variety of factors including the surgeon's experience, type of fistula, involvement of sphincter muscles, type of surgical procedure and patient-related factors. For the surgical treatment of a complex anal fistula, a variety of operative procedures have been described including fistulectomy with sphincterotomy, different flap procedures (e.g. mucosal flap and advancement flap) and finally so-called sphincter-preserving techniques, such as LIFT (ligation of intersphincteric fistula tract), VAAFT (video-assisted anal fistula treatment), the use of plugs of collagen or fibrin glue sealants as well as laser procedures or the clip. In the search for suitable quality indicators in anal fistula surgery there is a conflict between healing and preservation of continence. If potential quality indicators are identified the principles of anal fistula surgery must be adhered to and the appropriate selection of patients and procedures is of crucial importance to achieve high healing rates without compromising continence or inducing surgical revision due to abscesses or recurrence. Based on the available literature and guidelines, in the assessment of quality indicators considerable differences exist with respect to patient selection, etiology of anal fistulas and length of follow-up. Heterogeneity of treatment protocols lead to difficulties in a definitive assessment of which surgical treatment is the best option for complex anal fistulas.

[Quality indicators for surgery of rectal cancer : Evidence-based development of a set of indicators for quality]. / Qualitätsindikatoren für die Chirurgie des Rektumkarzinoms : Evidenzbasierte Entwicklung eines Indikatorensets für die Ergebnisqualität.

The definition of valid quality indicators is an essential task of medical self-administration and quality assurance. Based on the literature and the results of the Study, Documentation, and Quality Center (StuDoQ) Rectal Cancer Registry, we suggest the following QIs: rate of circumferential resection margin (CRM) positive resected material, rate of anastomotic leak in patients with anastomoses, rate of abdominal wound healing disorders and rate of patients with newly established permanent urinary diversion. Additionally, a new marker, the MTL30, which subsumes patient death within 30 days after the index operation, patient transfer to another acute hospital within 30 days after the index operation or a length of inpatient hospital stay of more than 30 days.

[Rectocele : Symptoms, diagnostics and therapy concepts from a coloproctological viewpoint]. / Rektozele : Symptome, Diagnostik und Therapiekonzepte aus koloproktologischer Sicht.

Anterior rectocele is a common morphological condition in patients with obstructive defecation syndrome. Typical symptoms include incomplete evacuation, transanal or transvaginal digitation and soiling, which is frequently interpreted as fecal incontinence. Diagnosis of rectocele is made clinically and functional assessment of rectocele can be performed by dynamic imaging, e.g. by magnetic resonance (MR) defecography. Primary treatment should be conservative. Concerning surgical treatment, transanal, transperineal, transvaginal and transabdominal procedures are available. Evidence-based guidelines for surgical treatment are still lacking. The question whether rectocele is a cause or a consequence of obstructive defecation syndrome remains controversial. Accordingly, indications for surgical correction of rectocele should be considered with caution.

[Indications, technique and results of the STARR procedure]. / Indikation, Technik und Ergebnisse der STARR-Operation.

Rectal intussusception and ventral rectocele are frequent morphological findings in patients suffering from obstructed defecation syndrome (ODS). After failed conservative treatment a surgical option can be discussed. Surgical approaches include the stapled transanal rectal resection (STARR) procedure, which is performed as a transanal approach by using two circular (PPH01) staplers for ventral and dorsal full-thickness resection of the distal rectum. Both retrospective and prospective studies as well as data from the German STARR registry demonstrated that the STARR procedure is safe and effective for symptom improvement and resolution in ODS associated with rectal intussusception in the short-term; however, disappointing functional results, particularly related to fecal incontinence and urgency, severe complications and high rates of revision surgery have also been documented. In general, based on the diagnostic and therapeutic challenges in ODS related to rectal intussusception, patient selection for STARR seems to be the key for success; therefore, this review summarizes and evaluates the indications, surgical technique, results, controversies and current trends of the "conventional" STARR procedure using two circular (PPH01) staplers.

Diagnosis and Therapy of Female Pelvic Organ Prolapse. Guideline of the DGGG, SGGG and OEGGG (S2e-Level, AWMF Registry Number 015/006, April 2016).

Aims: The aim was to establish an official interdisciplinary guideline, published and coordinated by the German Society of Gynecology and Obstetrics (DGGG). The guideline was developed for use in German-speaking countries. In addition to the Germany Society of Gynecology and Obstetrics, the guideline has also been approved by the Swiss Society of Gynecology and Obstetrics (SGGG) and the Austrian Society of Gynecology and Obstetrics (OEGGG). This is a guideline published and coordinated by the DGGG. The aim is to provide evidence-based recommendations obtained by evaluating the relevant literature for the diagnostic, conservative and surgical treatment of women with female pelvic organ prolapse with or without stress incontinence. Methods: We conducted a systematic review together with a synthesis of data and meta-analyses, where feasible. MEDLINE, Embase, Cinahl, Pedro and the Cochrane Register were searched for relevant articles. Reference lists were hand-searched, as were the abstracts of the Annual Meetings of the International Continence Society and the International Urogynecological Association. We included only abstracts of randomized controlled trials that were presented and discussed in podium sessions. We assessed original data on surgical procedures published since 2008 with a minimum follow-up time of at least 12 months. If the studies included descriptions of perioperative complications, this minimum follow-up period did not apply. Recommendations: The guideline encompasses recommendations for the diagnosis and treatment of female pelvic organ prolapse. Recommendations for anterior, posterior and apical pelvic organ prolapse with or without concomitant stress urinary incontinence, uterine preservation options, and the pros and cons of mesh placements during surgery for pelvic organ prolapse are presented. The recommendations are based on an extensive and systematic review and evaluation of the current literature and include the experiences and specific conditions in Germany, Austria and Switzerland.

Rectal mucosal prolapse in males: surgery is effective for fecal incontinence but not for obstructed defecation.

BACKGROUND: The aim of this prospective study was to evaluate the functional outcome of transanal surgery in male patients suffering from fecal incontinence, soiling, and obstructed defecation associated with rectal mucosal prolapse. METHODS: All male patients who underwent transanal surgery (either stapled or Delorme mucosectomy) for rectal mucosal prolapse associated with fecal incontinence and obstructed defecation were prospectively enrolled in the study. The recruitment phase was 17 months (April 2011 to August 2012). Symptom evaluation was based on the validated scores preoperatively and 12 months after surgery (Wexner incontinence score and Wexner constipation score). The primary end point was "success," which was defined as a 50 % reduction in symptoms. Using a decision-tree algorithm, patient groups with the highest and lowest chance of success were identified. RESULTS: Thirty-eight male patients (mean age 51 years) underwent transanal surgery for rectal mucosal prolapse. The predominant symptoms were fecal incontinence in 31 patients (82 %) and obstructed defecation in 7 (18 %). Stapled mucosectomy was performed in 34 patients and Delorme mucosectomy in 4 patients. No major morbidity occurred. Symptom resolution for soiling was 77 %, itching and mucus secretion were improved in 47 and 50 %, and bleeding resolved in 89 % of patients affected. Functional outcome was good in 90 % (28/31) of the patients with fecal incontinence but in only 28 % (2/7) for obstructed defecation. The Wexner incontinence score decreased significantly (11.1 vs. 3.9, p < 0.01), whereas the Wexner constipation score was not influenced (18.4 vs. 15.6, p > 0.05). Using a decision-tree algorithm, a success rate of 96 % was observed in patients with fecal incontinence associated with younger age (age <45 years) and no presence of fecal urgency prior to surgery. CONCLUSIONS: Transanal stapled mucosectomy for rectal mucosal prolapse in males is effective for fecal incontinence, but not for obstructed defecation.

Sacral neuromodulation for fecal incontinence and "low anterior resection syndrome" following neoadjuvant therapy for rectal cancer.

BACKGROUND: It was the aim of this prospective study to analyze both feasibility and effectiveness of sacral neuromodulation for fecal incontinence and "low anterior resection syndrome" following neoadjuvant therapy for rectal cancer. METHODS: All patients who underwent sacral neuromdulation following neoadjuvant therapy for rectal cancer (preoperative radiochemotherapy, oncologic rectal resection with total mesorectal excision) were prospectively enrolled in the study. Only patients with failure of conservative treatment and without any evidence of residual or recurrent tumor disease were candidates for sacral neuromdulation which was performed by a two-stage procedure (diagnostic percutaneous test stimulation followed by definite implant). In addition to feasibility, primary end points included success (reduction of incontinent episodes), continence and defecation status (assessed by Cleveland Clinic Incontinence Score and Altomare score), and quality of life (EQ-5D). Anal manometry was performed preoperative and at 12-month follow-up. Follow-up information was derived from clinical examination 3, 6, and 12 months postoperatively. RESULTS: Nine patients (three females, six males) with a mean age of 61 years underwent sacral neuromodulation following neoadjuvant therapy for rectal cancer. Implantation rate was 100 %. No septic morbidity was observed. After a mean follow-up of 12 months, mean Cleveland Clinic Incontinence Score was reduced from 18.2 to 6.0 (p < 0.01). Incontinence episodes were significantly reduced from 7 to 0.5 (per day) and 20 to 8 (per week). Fecal urgency, fragmented defecation, and soiling were improved or resolved in two thirds. Altomare score was significantly reduced from 21.0 to 9.3 (p < 0.01). Anorectal manometry did not correlate with clinical success. Quality of life was significantly improved (EQ-5D generic: 0.42 vs. 0.74, EQ-5D-VAS score: 20 vs. 90, p < 0.01). CONCLUSIONS: Preliminary results of sacral neuromodulation in patients with fecal incontinence and symptoms of "low anterior resection syndrome" are promising and enrich the therapeutic modalities if conservative management has failed.

Video-assisted anal fistula treatment (VAAFT) combined with advancement flap repair in Crohn's disease.

BACKGROUND: It was the aim of this prospective study to analyze both the feasibility and preliminary results of video-assisted anal fistula treatment (VAAFT) combined with advancement flap repair for complex fistulas in Crohn's disease. METHODS: All patients with perianal Crohn's disease suffering from complex fistulas who underwent definitive surgery using VAAFT combined with advancement flap repair were prospectively enrolled in the study. Only complex fistulas with concurrent stable disease and without any evidence of severe inflammatory activity or perianal sepsis were treated using the VAAFT technique. Patients with Crohn's proctitis or prior proctectomy were not candidates for the procedure. VAAFT was performed by using the VAAFT equipment (Karl Storz, Tuttlingen, Germany). Key steps included visualization of the fistula tract and/or side tracts using the fistuloscope and correct localization of the internal fistula opening under direct vision with irrigation. Diagnostic fistuloscopy was followed by advancement flap repair. In addition to feasibility, primary end points included detection of side tracts, success and continence status (assessed by the Cleveland Clinic Incontinence Score). Success was defined as closure of both internal and external openings, absence of drainage without further intervention and absence of abscess formation. Follow-up information was derived from clinical examination 3, 6 and 9 months postoperatively. RESULTS: Within a 3-month observation period (September to November 2011), VAAFT was attempted in 13 patients with Crohn's associated complex fistulas. The completion rate was 85% (11/13). In these 11 patients (median age 34 years, 64% females), complex fistulas were transsphincteric (8), suprasphincteric (2) and recto-vaginal (1). Forty-six percent (5/11) had concomitant therapy with biologic drugs. In 36% (4/11), VAAFT was performed with fecal diversion. Median duration of surgery was 22 (range 18-42) minutes. Using VAAFT, additional side tracts not detected preoperatively could be identified in 64% (7/11). No morbidity occurred. After a mean follow-up of 9 months, the success rate was 82% (9/11). No deterioration of continence was documented (Cleveland Clinic Incontinence Score 2.4 vs. 1.6, p > 0.05). CONCLUSION: Preliminary results of the addition of the VAAFT technique to advancement flap repair in Crohn's fistulas demonstrate that this leads to a high identification rate of occult side tracts with encouraging short-term healing rates. Moreover, a completion rate of 85% seems promising.

[Significance of conservative treatment for faecal incontinence]. / Stellenwert der konservativen Therapie bei Stuhlinkontinenz.

Based on a variety of aetiological factors and combined disorders in faecal incontinence, a conservative treatment option as the primary treatment can be recommended. Conservative treatment includes medical therapy influencing stool consistency and stool passage, pelvic floor exercises and biofeedback as well as local treatment options. However, defining the role of conservative treatment concepts related to success or failure remains a challenging task. The lack of evidence derived from studies is related to a variety of reasons including inclusion criteria, patient selection, treatment standardisation, and the principal difficulty to objectively define functional success.

Obesity is a negative predictor of success after surgery for complex anal fistula.

BACKGROUND: It was the aim of this study to compare the outcome of surgery for complex anal fistulas in obese and non-obese patients. METHODS: All patients with complex anorectal fistulas who underwent fistulectomy and/or rectal advancement flap repair were prospectively recorded. Surgery was performed in a standardized technique. Body mass index (BMI [kg/m2]) was used as objective measure to indicate morbid obesity. Patients with a BMI greater than 30 were defined as obese, and patients with a BMI below 30 were defined as non-obese. The parameters analyzed related to BMI included success or failure, and reoperation rate due to recurrent abscess. Success was defined as closure of both internal and external openings, absence of drainage without further intervention, and absence of abscess formation. RESULTS: Within two years, 220 patients underwent advancement flap repair and met the inclusion criteria. 55% of patients were females, mean age was 39 (range 18-76) years, and the majority of fistulas were located at the posterior site. 69% of patients (152/220) were non-obese (BMI < 30), whereas 31% (68/220) were obese (BMI > 30). After a median follow-up of 6 months, primary healing rate ("success") for the whole collective was 82% (180/220). Success was significantly different between non-obese and obese patients: In non-obese patients, recurrence rate was significantly lower than in obese patients (14% vs. 28%; p < 0.01). Moreover, reoperation rate due to recurrent abscess with the need for seton drainage in the failure groups was significantly higher in obese patients when compared to non-obese patients (73% vs. 52%; p < 0.01). Using multivariate analysis, obesity was identified as independent predictive factor of success or failure (p < 0.02). CONCLUSION: Obese patients are at higher risk for failure after surgery for complex anal fistula.

Conversion in transanal stapling techniques for haemorrhoids and anorectal prolapse.

AIM: It was the aim of this single-surgeon series to assess the role of conversion in transanal stapling to techniques and to identify potential factors predictive of conversion. METHOD: The details of all consecutive patients who were planned for a stapled approach were prospectively recorded in a PC database. Stapling techniques (PPH03, PPH01 and ContourTranstar) were indicated for haemorrhoidal disease and internal rectal prolapse. 'Conversion' from a stapled approach was defined as an unplanned change of the surgical method to a nonstapled, traditional technique, related to indication, anatomy and technical factors. The primary outcomes were whether the procedure was performed using a stapling device only, or whether the procedure was converted. Logistic regression analysis was performed to evaluate multiple variables as potential risk factors for conversion. RESULTS: In a 2-year period (May 2006-May 2008), 258 patients met the inclusion criteria and underwent transanal surgery scheduled as a stapled approach. In these 258 patients, 246 procedures were completed as a stapled procedure [that stapled haemorrhoidopexy, n = 148; stapled mucosectomy, n = 52; stapled transanal rectal resection (STARR) with PPH01, n = 38; and STARR with ContourTranstar, n = 8], giving a completion rate of 95.4%. However, 12 procedures were converted to conventional surgery (including traditional haemorrhoidectomy and the Delorme procedure), giving a conversion rate of 4.6%. The reasons for conversion were related to anatomy and to clinical findings (nonreducible haemorrhoidal prolapse), to new clinical findings not detected preoperatively (proctitis, anal fistula) and to a technical inability to insert the circular anal dilatator because of a deep anal canal. Neither univariate nor multivariate analysis identified any factor to be specifically associated with the risk of conversion. CONCLUSION: In the era of transanal stapling procedures for haemorrhoids and anorectal prolapse, the majority of procedures can be performed using stapled techniques if strict criteria of indication and patient selection are respected. However, the current study identified a 4.6% conversion rate to traditional treatment, which has an impact on informed consent and requires the surgeon to be familiar with conventional anorectal procedures.

Stapled transanal rectal resection for obstructed defecation syndrome: one-year results of the European STARR Registry.

PURPOSE: Stapled transanal rectal resection is advocated for the treatment of obstructed defecation syndrome. Supporting evidence for its safety and effectiveness has been lacking. To address this, the European Stapled Transanal Rectal Resection Registry was initiated in January 2006. This study was designed to analyze 12-month postoperative outcomes of this procedure using data collected in the registry. METHODS: On May 17, 2008, data were downloaded from the Stapled Transanal Resection Registry to perform an analysis of 12-month outcomes. Data had been collected prospectively on effectiveness (symptom severity and obstructed defecation scores), quality of life, incontinence, and safety profile at baseline, 6 weeks, 6 months, and 12 months. RESULTS: A total of 2,838 patients were entered into the registry, of whom 2,224 had reached 12 months of follow-up. Mean age was 54.7 years. A total of 2,363 patients (83.3%) were female. A significant improvement was seen in obstructive defecation and symptom severity scores and quality of life between baseline and 12 months (obstructed defecation score: 15.8 vs. 5.8, respectively, P < 0.001; symptom severity score: 15.1 vs. 3.6, respectively, P < 0.001). Complications were reported in 36.0% and included defecatory urgency (20.0%), bleeding (5.0%), septic events (4.4%), staple line complications (3.5%), and incontinence (1.8%). One case of rectal necrosis and one case of rectovaginal fistula were reported. CONCLUSION: Stapled transanal rectal resection produces improved function and better quality of life for patients with obstructed defecation that is maintained at 12 months of follow-up. Further investigation is required to optimize patient selection and reduce the potential complications of postoperative defecatory urgency and pain.

Innovative technique for the closure of rectovaginal fistula using Surgisis mesh.

BACKGROUND: The aim of this prospective study was to analyse the efficacy of Surgisis mesh for closure of rectovaginal fistulas. Prospective data were collected from two centres. METHODS: All patients with a rectovaginal fistula who underwent definitive surgery using Surgisis mesh were prospectively enrolled in this study. Inclusion criteria included a rectovaginal fistula in the lower two-thirds of the rectovaginal septum. Surgery was performed with a standardized technique including combined transrectal and transvaginal excision of the rectovaginal fistula with transvaginal placement of the mesh. Success was defined as closure of both internal and external (perianal and vaginal) openings, absence of drainage without further intervention, and no abscess formation. RESULTS: Over a period of 16 months, a total of 21 mesh procedures were performed in two centres. The mean age of the patients was 47 years (18-59 years). Of the 21 patients, 18 (86%) had recurrent rectovaginal fistula, and the mean number of prior attempts was 2.3 (0-8). The majority of patients (nine) had Crohn's disease-associated fistula, followed by six with iatrogenic fistula, two with radiation-induced fistula, two with obstetric injury-induced fistula, and two with idiopathic fistula. The mesh procedure was performed under faecal diversion in eight patients (38%). The mean operative time was 38 min; no intraoperative morbidity occurred. Patients were discharged from hospital on day 4. After a mean follow-up of 12 months (range, 3-18 months), the overall success rate after primary mesh procedure was 71% (15/21; 6 patients had failure or recurrence). All patients with failure or recurrence were reoperated upon. Out of these six patients who were reoperated upon, four had definite healing (75%). Among the eight patients who had faecal diversion, four (50%) had reversal of their stoma. CONCLUSION: The preliminary success rate for this innovative technique using Surgisis mesh for the closure of rectovaginal fistulas is promising. Further studies are needed to assess the definite role of this novel technique in comparison to traditional surgical procedures.

STARR with Contour Transtar: prospective multicentre European study.

OBJECTIVE: The stapled transanal rectal resection (STARR) in patients with defecation disorders is limited by the shape and capacity of the circular stapler. A new device has been recently developed, the Contour Transtar stapler, in order to improve the safety and effectiveness of the STARR technique. The study has been designed to confirm this declaration. METHOD: From January to June 2007 a prospective European multicentre study of consecutive patients with defecation disorder caused by internal rectal prolapse underwent the new STARR technique. The assessment of perioperative morbidity and functional outcome after 6 weeks, 3 and 12 months was documented by different scores. RESULTS: In all 75 patients, median age 64, the Transtar procedure was performed with 9% intraoperative difficulties, 7% postoperative complications and no mortality. The mean reduction of the ODS score was -15.6 (95%-CI: -17.3 to -13.8, P < 0.0001), mean reduction of SSS was -12.6 (95%-CI: -14.2 to -11.2; P < 0.0001). 41% stated improvement of their continence status by CCF score, only 4 patients (5%) had deterioration. CONCLUSION: The Transtar procedure is technically demanding, with good functional results similar to the conventional STARR.

Innovative management of anal fistula by the use of the anal fistula plug: hype or help?

Impressed by the initial success rates of 80% of the anal fistula plug for the closure of cryptoglandular and Crohn's associated anorectal fistulas, preliminary results from centers world-wide showed a healing rates between 24% and 88%. When compared to traditional flap repair for closing high anorectal fistulas, impairement of continence may be decreased using the plug procedure. Analyzing the different experiences of the plug procedure ranging from promising to disappointing results, a variety of issues such as bowel preparation, treatment of fistula tract, closure of the internal opening, and postoperative management have to be considered. Furthermore, the ''ideal'' indication has still to be defined. At the moment, all results which have been published only provide short-term results, and the question whether the plug procedure is appropriate and effective in Crohn's disease cannot be answered definitely. Finally, the question how to proceed in patients with plug dislodgement or failure remains unclear. In general, the introduction of the plug has accelerated a ''new'' discussion on the optimal treatment of complex fistulas. Further analysis is needed to explain the definite role of this innovative technique in comparison to traditional surgical techniques.

Patient mood and neuropsychological outcome after laparoscopic and conventional colectomy.

The study was designed to compare patients after laparoscopic and conventional colectomy with regard to early postoperative mood, cognitive function, and neurocognitive variables S100beta and neuron-specific enolase (NSE). Forty-five laparoscopic and 25 open colectomies were enrolled into the prospective study. Outcome measurements were positive and negative postoperative mood (BSKE), neuropsychological tests (Trail-Making Test; word reproduction; Stroop Test), and serum biochemical parameters (S100beta; NSE). Following laparoscopic procedure, patients described significantly better positive mood (P< .05), tended to require less time in the Trail-Making Test and Stroop Test, and had lower postoperative serum concentrations of S100beta compared to conventional colectomy patients (P< .01). The current results revealed several group differences, which, in their entirety, seem to represent a more beneficial outcome after laparoscopic colonic surgery.

[Actual Role of Stapled Transanal Rectal Resection (STARR) for obstructed defecation syndrome]. / Aktueller Stellenwert der transanalen Stapler-Resektion des distalen Rektums (STARR) bei obstruktivem defäkations-syndrom.

Internal rectal prolapse (rectal intussusception) and rectocele are frequent clinical findings in patients suffering from refractory constipation that may be best characterized as "obstructive defecation syndrome" (ODS). However, there is still no clear evidence whether the STARR procedure (stapled transanal rectal resection) provides a safe and effective surgical option for symptom resolution in ODS patients, as evidence-based guidelines and functional long-term results of representative collectives are still lacking. Based on published data derived from the German STARR registry, the STARR procedure can be performed safely with low morbidity. The definitive role of the STARR procedure has to be assessed by careful and prospective evaluation of long-term function, symptom resolution, and quality of life, e. g., as provided by the German STARR registry.