Fecal Incontinence Quality Of Life Scores Research Articles

Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn's perianal fistulas.

Patients with Crohn's disease (CD) are at risk of developing complications such as perianal fistulas. Patients with Crohn's perianal fistulas (CPF) are affected by fecal incontinence (FI), bleeding, pain, swelling, and purulent perianal discharge, and generally face a higher treatment burden than patients with CD without CPF. To gain insights into the burden of illness/quality of life in patients with CPF and their treatment preferences and satisfaction. This cross-sectional observational study was conducted in patients with CD aged 21-90 years via a web-enabled questionnaire in seven countries (April-August 2021). Patients were recruited into three cohorts: Cohort 1 included patients without perianal fistulas; cohort 2 included patients with perianal fistulas without fistula-related surgery; and cohort 3 included patients with perianal fistulas and fistula-related surgery. Validated patient-reported outcome measures were used to assess quality of life. Drivers of treatment preferences were measured using a discrete choice experiment (DCE). In total, 929 patients were recruited (cohort 1, n = 620; cohort 2, n = 174; cohort 3, n = 135). Short Inflammatory Bowel Disease Questionnaire scores were worse for patients with CPF (cohorts 2 and 3) than for those with CD without CPF (cohort 1): Mean score 3.8 and 3.7 vs 4.1, respectively, (P < 0.001). Similarly, mean Revised FI and FI Quality of Life scores were worse for patients with CPF than for those with CD without CPF. Quality of Life with Anal Fistula scores were similar in patients with CPF with or without CPF-related surgery (cohorts 2 and 3): Mean score 41 and 42, respectively. In the DCE, postoperative discomfort and fistula healing rate were the most important treatment attributes influencing treatment choice: Mean relative importance 35.7 and 24.7, respectively. The burden of illness in CD is significantly higher for patients with CPF and patients rate lower postoperative discomfort and higher healing rates as the most desirable treatment attributes.

An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence

BackgroundImplantation of Gatekeeper™ prostheses presents an option for the treatment of passive faecal incontinence (FI). Whilst preliminary results are encouraging, long-term data regarding its sustained benefit are limited. The aim of this study was to assess and evaluate the long-term clinical function and quality of life of patients with passive faecal incontinence who were treated with Gatekeeper™ prostheses.MethodsThis was a single centre, single surgeon retrospective study of prospectively collected clinical data in patients with FI treated between June 2012 and May 2019. Patients with passive FI with symptoms refractory to conservative treatment and endoanal ultrasonography showing intact or disrupted internal anal sphincter were included. Formal clinical and quality of life assessments were carried out using the St. Mark’s Incontinence Score (SMIS) and Faecal Incontinence Quality of Life (FIQoL) questionnaires at baseline, 3 months, 6 months, 12 months and then annually. Endoanal ultrasonography was performed both before and after surgery.ResultsForty patients (14 males, 26 females) with a median age of 62.5 (range 33–80) years were treated with the Gatekeeper™ implant. The majority of patients (87.5%) received six implants. There were no peri or post-operative complications. Prosthesis migration was observed in 12.5% patients. The median follow-up duration was 5 years (interquartile range (IQR) 3.25–6.00 years). A sustained improvement in median SMIS and FIQoL scores from baseline to follow-up was noted. Significant differences were observed between the median baseline SMIS score and last follow-up score of 16.00 (IQR 15.00–16.75) to 7.00 (IQR 5.00–8.00) respectively (p < 0.001), a 56.25% decrease. The overall median FIQoL score showed a significant improvement from 7.95 (IQR 7.13–9.48) to 13.15 (IQR 12.00–13.98) (p < 0.001) a 65.40% increase.ConclusionsGatekeeper™ implantation is a safe approach to treating passive FI and is minimally invasive, reproducible and has minimal complications. Long-term sustained clinical improvement is achievable beyond 5 years. Careful patient selection is paramount, as is consistency of technique and follow-up protocol.

Patient-Reported Bowel and Urinary Function in Long-Term Survivors of Squamous Cell Carcinoma of the Anus Treated With Definitive Intensity Modulated Radiation Therapy And Concurrent Chemotherapy

Definitive radiation therapy with concurrent chemotherapy is curative for nonmetastatic squamous cell carcinoma of the anus (SCCA). However, the true effect of chemoradiation on long-term functional outcomes is poorly understood owing to limited follow-up and patient-reported outcomes (PROs). We conducted a cross-sectional survey of 248 patients with SCCA treated with definitive intensity modulated radiation and concurrent chemotherapy from 2010 to 2018 who were alive and without recurrence. PRO measures were collected, including Functional Assessment of Cancer Therapy-General (FACT-G7), Fecal Incontinence Quality of Life (FIQoL), Low Anterior Resection Syndrome (LARS), and International Consultation on Incontinence Questionnaires (ICIQ). Models were used to determine the association between demographic, tumor, treatment, and dosimetric data with PROs. One hundred twelve (45%) patients completed PROs. Median [interquartile range (IQR)] time from radiation completion to survey was 51 [37-85] months. The median scores [IQR] for FACT-G7, FIQoL, and LARS were 21 [15-24], 14 [11-16], and 32 [25-37], respectively. For men, median subscores [IQR] for ICIQ voiding and incontinence subscores were 5 [2-6] and 1 [1-3], respectively. For women, median subscores [IQR] for ICIQ voiding, incontinence, and filling were 1 [1-3], 5 [3-8], and 4 [2-5], respectively. Higher (better) FIQoL scores were associated with higher (better) FACT-G7 scores (β=0.83; 95% confidence interval, 0.58-1.09; P < .001), and higher (worse) LARS scores were associated with lower (worse) FACT-G7 scores (β=-0.22; 95% confidence interval, -0.31 to -0.13; P < .001). A separate multivariable analysis revealed higher bowel bag D1% was associated with lower (worse) FIQoL (P=.001) and higher (worse) LARS (P=.003) scores. Higher bladder V40 Gy was associated with increased (worse) ICIQ voiding subscore (P=.001). Patients treated with modern chemoradiation for SCCA experience significant long-term bowel toxic effects with considerable effect on quality of life. Minimizing bowel hotspots and bladder V40 Gy may improve bowel and urinary function. Other interventions to reduce long-term toxic effects and improve quality of life are needed.

Application of nanofat for treatment of traumatic faecal incontinence after sphincteroplasty - A pilot study.

The aim of this study was to investigate whether the application of nanofat containing stem cells improves continence in women who had previously undergone anal sphincteroplasty with unsatisfactory long-term outcomes. This prospective pilot study included nine women with various degrees of anal incontinence who had previously undergone anal sphincteroplasty due to obstetric trauma. In all patients, the Wexner Incontinence Score (WS) and Faecal Incontinence Quality of Life Score (FIQLS), as well as anal manometry and endoanal ultrasound measurements, were performed before the procedure and during follow-up. In all patients, liposuction was performed and 50ml of raw lipoaspirate was obtained and processed using a NanoFat Kit device. Approximately 20ml of the mechanically emulsified and filtrated fat was obtained and the anal sphincter complex was infiltrated with it. Patient follow-up was conducted in person or via telephone 6 and 12months after the procedure. The squeeze pressure was significantly increased 6 months after the procedure (p= 0.01). The external anal sphincter measured at the 12 o'clock position was significantly thicker (p= 0.04). A significant decrease in the WS was observed both 6 and 12months after the procedure compared with baseline values (p< 0.05 for both). This study is the first to show that the application of nanofat as an injectable product improves continence in patients with unsatisfactory results after sphincteroplasty, suggesting it to be a promising and effective therapeutic tool. The procedure is safe and can be easily performed as an ambulatory procedure.

Sphincter-Preserving Fistulectomy Is an Effective Minimally Invasive Technique for Complex Anal Fistulas.

BackgroundThe optimal treatment of complex anal fistulas remains unclear, though many different sphincter-preserving procedures have been described. A minimally invasive technique with a better outcome is desired. The purpose of this study was to present a new technique—sphincter-preserving fistulectomy (SPF) and its clinical outcomes.Materials and MethodsA retrospective study was performed to compare the efficacy and outcomes of SPF with ligation of the intersphincteric fistula tract (LIFT) in the management of complex anal fistulas in regards to postoperative pain, complications, wound healing time, recurrence, overall success rate, fecal continence function, and quality of life. Continence function was evaluated using the Wexner incontinence scale and anal manometry. The fecal incontinence quality of life (FIQL) scale was used to assess patients' quality of life.ResultsFrom June 2020 to July 2021, 41 patients with 43 SPF procedures and 35 patients with 35 LIFT procedures were included. Postoperative pain was comparable between two groups. The morbidity rate and the mean wound healing time in the SPF group were lower than those in the LIFT group (2.3% vs. 48.6%, p < 0.001; 1.4 ± 0.3 vs. 1.7 ± 0.4 months, p = 0.001). At a mean follow-up duration of 11.4 ± 3.5 months in the SPF group and 10.7 ± 4.3 months in the LIFT group, SPF achieved a better overall success rate than LIFT (97.7% vs. 77.1%, p = 0.014). Three patients in the SPF group and 4 patients in the LIFT group who all underwent a simultaneous fistulotomy procedure complained new incontinence of flatus. There was no statistical difference between the two groups in regards to the Wexner scores (p = 0.790), the maximum resting anal canal pressure (p = 0.641), the maximum squeeze pressure (p = 0.289), and the FIQL scores including lifestyle (p = 0.188), coping (p = 0.188), depression (p = 0.850), and embarrassment (p = 0.910).ConclusionsSPF is a novel, safe, and effective minimally invasive technique for the management of complex anal fistulas, with a promising success rate and negligible impairment on continence. Future prospective studies are needed to evaluate the long-term outcomes of SPF.

Association between Fecal Incontinence and Lower Urinary Tract Symptoms and their Impact on the Quality of Life of Patients with Prostate Cancer

Abstract Objective To evaluate the association of fecal incontinence (FI) and lower urinary tract symptoms (LUTS) in patients diagnosed with initial prostate cancer (PC) and after any therapeutic approach (surgery and radiotherapy). Methods Cross-sectional study using the Cleveland Clinic Incontinence Score (CCIS), the Fecal Incontinence Quality of Life (FIQL) questionnaire, and the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Results A total of 84 patients with PC were included: 40 of them had not started treatment, 31 were submitted to radical prostatectomy (RP), and 13 were submitted to radiotherapy (RT). Those submitted to RT presented higher scores on the ICIQ-OAB (p = 0.01). When comparing the whole sample reagarding the patients with and without FI, we observed that the incontinents presented a higher frequency of urinary incontinence (UI) (p &lt; 0.001). Moreover, when comparing patients with/without FI within their treatment groups regarding the presence of UI and FIQL scores, we identified that patients undergoing RP presented an association between UI and FI (p &lt; 0.001) and a greater impact of FI on the FIQL (p &lt; 0.001). Conclusion Patients submitted to RT present more intense LUTS. Moreover, patients with FI present a higher association with UI, and this association is more marked in those with FI submitted to RP.

The Minimal Important Difference of the Fecal Incontinence Quality of Life (FIQL) Questionnaire for Patients with Posterior Compartment Prolapse: A Prospective Cohort Study.

Objectives: The minimally important difference (MID) of the Fecal Incontinence Quality of Life (FIQL) scale has never been determined. Thus, in this study, we aimed to estimate the MID of the Japanese FIQL for patients with posterior compartment prolapse (PCP). Methods: For 3-months after surgery, we followed a prospective cohort of 136 patients with PCP combined with fecal incontinence (FI) who had undergone ventral rectopexy between 2012 and 2018. Usable data from 114 patients were analyzed. Patients have both completed the FIQL and the 36-Item Short Forum Health Survey (SF-36) before and after surgery. Distribution-based MID values were estimated at 1/2 SD and the standard error of measurement (SEM) for domain and total scores across time points. Changes in the domain scores anchored to changes in a SF-36 overall health assessment question were used to estimate anchor-based MID. To be interpreted as true change, the median, anchor-based MID values that were greater than the corresponding SEM were proposed as estimates of the MID for the FIQL. Results: Distribution-based MID of 1/2 SD for each domain and total score ranged between 0.3 and 0.4, whereas SEM ranges were between 0.2 and 0.3. The anchor-based approach resulted in the median MID estimates of 0.4 to 1.0. Final estimates of MID for each FIQL and total score were as follows: lifestyle (0.6-1.1), coping/behavior (0.8-1.4), depression/self-perception (0.4-0.8), embarrassment (1.0-1.6), and total score (0.7-1.1). Conclusions: The results provide a basis for clinically important differences in FIQL scores after surgery for patients with PCP and FI.

P585 Examining faecal incontinence and its impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a multi-country burden of illness study

Abstract Background Perianal fistulas (PAF) are a common complication associated with Crohn’s disease (CD), and patients with Crohn’s perianal fistulas (CPF) are more likely to experience faecal incontinence (FI) than patients with CD without PAF (non-PAF CD). A global study was conducted to assess the burden of illness in patients with CPF compared with patients with non-PAF CD. Here, we present data on the level of FI and its impact on quality of life (QoL). Methods This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort 1) or CPF without PAF-related surgery (cohort 2) or CPF with PAF-related surgery (cohort 3). Validated, general and disease-specific patient-reported outcome data were collected using a 45-min IRB/EC-approved web-enabled questionnaire. The level of FI was evaluated using the Revised Faecal Incontinence Score (RFIS) (1–20 scale, 0 = no incontinence, 4-week recall period) and the impact of FI on QoL in patients who had experienced FI using the Fecal Incontinence Quality of Life (FIQL) (1–5 scale, 1 = lower QoL). Data were analysed using descriptive statistics. Results Of the 929 patients recruited (cohort 1, n = 620; cohort 2, n = 174; cohort 3, n = 135), 58–69% were male and 55–67% were aged 21–40 years across all cohorts. A significantly higher proportion of patients in cohort 3 than cohort 1 had severe Crohn’s disease as classified by a physician (18% vs 9%, respectively; p &amp;lt; 0.05). Overall, 47% of patients reported experiencing FI and completed both the RFIS and FIQL. Significantly higher proportions of patients in cohorts 2 and 3 had experienced FI than in cohort 1 (59% and 59% vs 40%, respectively; p &amp;lt; 0.05), and a significantly higher proportion were currently experiencing FI in cohort 3 than in cohorts 1 and 2 (69% vs 37% and 45%, respectively; p &amp;lt; 0.05). Mean RFIS scores were significantly higher (worse) in cohorts 2 and 3 than cohort 1 (9.5 [p &amp;lt; 0.05] and 10.6 [p &amp;lt; 0.001] vs 8.2, respectively). Patients in cohort 2 had significantly lower (worse) FIQL scores than those in cohort 1 across three FIQL domains (lifestyle [2.2 vs 2.4], depression/self-perception [2.1 vs 2.3], embarrassment [2.2 vs 2.4]; p &amp;lt; 0.05), whereas patients in cohort 3 only reported significantly lower FIQL scores compared with cohort 1 in the embarrassment domain (2.2 vs 2.4; p &amp;lt; 0.05). Conclusion In this study almost half of the patients experienced faecal incontinence. Among those who experienced faecal incontinence, patients with PAF experienced a significantly higher impact on their quality of life compared with patients without PAF.

Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study.

AimsThere is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion‐based VBF device and app was effective for at‐home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms.MethodsA single‐arm 10‐week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2‐week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed‐rank test.ResultsOf 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10‐weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p < 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052).ConclusionsIn this pilot study, there was significant improvement in FI symptom‐specific severity and quality of life using a vaginal, motion‐based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting.

DOP38 An observational study to evaluate the burden of illness in patients with Crohn’s Disease with and without perianal fistulas in the USA

Abstract Background Crohn’s disease (CD) is a chronic inflammatory condition of the gastrointestinal tract that can lead to complications such as perianal fistulas (PAFs). This study compared disease burden, experiences and health-related quality of life between patients who have CD with PAFs (CPF) and those who have CD without PAFs (non-PAF CD). Methods This cross-sectional, observational study was conducted in three cohorts of US patients aged 18–89 years with self-reported physician-diagnosed CD: (1) non-PAF CD; (2) CPF without PAF-related surgery; and (3) CPF with PAF-related surgery. Data on medical and surgical interventions, CD-specific symptoms and Fecal Incontinence Quality of Life (FIQL) were collected via a web-enabled questionnaire. Statistical comparisons were assessed at the 0.05 level. Results The mean (standard deviation) age of patients in cohorts 1 (n = 300), 2 (n = 51) and 3 (n = 52) was 47 (16.4), 40 (12.2) and 39 (13.1) years, respectively. In patients with CPF (cohort 2 + 3), 59 (57%) reported multiple fistulas and 48 (47%) reported fistula recurrence/persistence. Compared with cohort 1 (non-PAF CD), more patients with CPF reported currently receiving biologic treatment or immunomodulators for CD (58% vs 43% and 23% vs 15%, respectively; both p = 0.01). More patients with CPF also reported undergoing ≥ 1 CD-related surgery and experiencing ≥ 1 failures of CD-related surgery (79% and 20%, respectively) versus cohort 1 (53% and 9%, respectively; both p &amp;lt; 0.001). In cohort 3, 63% of patients had ≥ 3 PAF-related surgeries, and in those receiving seton placement (n = 37), 8% reported placement failure. Post-surgical/seton placement complications were common; the most frequently reported were worsening of pain and swelling around the anus (33%) and fever/infection (29%). CD-specific symptom frequency and severity results indicated a high symptom burden across cohorts; fatigue was reported with the highest frequency and severity. Faecal incontinence (FI) and leakage-related symptoms affected greater proportions of patients in cohorts 2 and 3, often with greater severity and frequency, compared with cohort 1 (Fig.1). Across all cohorts, 58% of patients (cohort 1/2/3, n = 158/35/40) reported experiencing FI and completed the FIQL questionnaire: cohorts 2 and 3 reported lower (worse) FIQL scores across domains than cohort 1 (Fig.2). Conclusion The burden of illness in patients with CPF is substantial, with medical and surgical intervention rates, and symptom severity and frequency greater than for those with non-PAF CD. Higher disease burden, including FI, was noted in patients with CPF compared with the non-PAF CD cohort. An unmet need remains for improved management and outcomes of CPF. Sponsor: Takeda Pharmaceuticals USA, Inc.

Sphinkeeper™ for faecal incontinence: a preliminary report.

AimA new artificial anal sphincter placed into the intersphincteric space, SphinKeeper™, has recently been proposed to improve outcomes in the treatment of faecal incontinence (FI). We report our preliminary results with short‐term follow‐up, comparing preoperative and postoperative data after implant of SphinKeeper™ in patients suffering from FI.MethodsAll patients older than 18 years were included with FI of at least 6 months, incontinence episodes occurring more than once a week and resistance to other conservative treatments. Anorectal manometry, endoanal ultrasound, Cleveland Clinic FI Score, FI Quality of Life score and total number of episodes of FI per week were recorded preoperatively and at the end of the 6‐month follow‐up period.ResultsThirteen consecutive patients were treated with SphinKeeper™. No intra‐operative nor postoperative complications were reported. Two cases of prosthesis extrusion occurred, and in one case an anterior dislocation was detected. Maximum resting pressure, total number of episodes of FI per week and Cleveland Clinic FI Score were improved after 6 months (P < 0.05).ConclusionsSphinKeeper™ could be a minimally invasive procedure for FI with good postoperative outcomes. If these results are confirmed by studies with more patients and longer follow‐up, it could be a first‐line approach in FI.

The effect of artificial anal band on quality of life of patients with fecal incontinence

Aim: The aim of this study was to evaluate incontinence levels before and after implantation of an artificial anal band (AAB), and to evaluate the change in quality of life of patients with fecal incontinence. Material and Methods: Patients with fecal incontinence who underwent AAB implantation were included in the study. The Cleaveland Clinic/Wexner Incontinence Score (CCIS) and Fecal Incontinence Quality of Life (FIQoL) scales were evaluated before, 2 weeks and 5 years post-implantation.Results: Eight patients underwent AAB implantation. The mean±SD pre-operative CCIS decreased significantly (p0.001) from 19.4±0.5 to 3.1±0.6 two weeks after AAB activation. Similarly, a significant improvement was observed between mean pre- and post-operative FIQoL scores (49.4 vs. 102.0; p=0.012). Most (62.5%) of the patients could actively use the implant. Surgical revision was performed in the post-operative period in 50% of the patients (n=4, 3 women). In 2 (25%) patients, AAB was explanted either due to a secondary surgical site infection (n=1, man) or due to a perianal skin maceration (n=1, man). Conclusion: AAB implantation is an effective treatment option for improving quality of life in patients with fecal incontinence. Appropriate patient selection criteria may improve explantation and surgical revision rates and increase the rate of effective use of AAB. Keywords: Fecal; incontinence; artificial anal band; efficacy; quality of life.

Reliability and validity of the simplified Chinese version of the fecal incontinence quality of life questionnaire in the patients with fecal incontinence

Objective: To develop the Chinese version of the fecal incontinence quality of life (FIQL) questionnaire, and to validate them in Chinese population. Methods: Our study included 52 cases recruiting from outpatients diagnosed with fecal incontinence in Peking Union Medical College Hospital, fecal incontinence in Beijing City nursing homes for the elderly, and patients received perineal repair surgeries who suffered from perineal laceration and laceration in in Peking Union Medical College Hospital from October 2013 to 2016 December.The Original English Fecal Incontinence Quality of Life scale questionnaires were translated into Chinese and they were linguistically validated following the Cross-cultural adaptation of health-related quality of life measures.The reliability and validity of the Chinese version of FIQL questionnaires in Chinese population were evaluated. Results: Fifty-two patients completed the FIQL and the SF-12 questionnaires, as well as Cleveland Clinic Incontinence Score.The Cronbach's alpha of FIQL was 0.949, test-retest reliability ICC was 0.437-0.866. FIQL scores were positively correlated with SF-12 (Spearman correlation coefficient was 0.588, P<0.01) and negatively correlated with Cleveland Clinic Incontinence Score (Spearman correlation coefficient was -0.617, P<0.01). Factor analysis showed that there were 6 common factors in FIQL. Conclusions: Chinese version of FIQL have high reliability and validity in Chinese population, there fore it is suitable for clinic and research.

Laparoscopic Vaginal Suspension and Rectopexy for Rectal Prolapse.

PurposeLaparoscopic procedures for the treatment of patients with a rectal prolapse have gained increasing worldwide acceptance because they have lower recurrence and better functional outcome than perineal procedures. Nevertheless, ideal surgical methods are still not available. We propose a new surgical technique, laparoscopic vaginal suspension and rectopexy, for correcting a full-thickness rectal prolapse and/or middle-compartment prolapse. This study assessed the short-term outcomes for patients who underwent laparoscopic vaginal suspension and rectopexy.MethodsBetween April 2014 and April 2016, 69 female patients underwent laparoscopic vaginal suspension and rectopexy to correct a rectal prolapse. Demographics, medical histories, and surgical and follow-up details were collected from their medical records. In addition to the clinical outcome, we repeated defecation proctography and a questionnaire regarding functional results three months after surgery.ResultsNo major morbidities or no mortalities occurred. The defecation proctography confirmed excellent anatomical result in all cases. Of 7 patients with combined middle-compartment prolapses, we observed good anatomical correction. During follow-up, full-thickness recurrence occurred in one patient. Preoperative fecal incontinence was improved significantly at 3 months (mean Wexner score: 12.35 vs. 7.71; mean FISI: 33.29 vs. 21.07; P < 0.001). Analysis of responses to the fecal incontinence quality of life (FIQOL) questionnaire showed overall improvement at 3 months compared to the preoperative baseline (mean pre- and postoperative FIQOL scores: 12.11 vs. 14.39; P < 0.004).ConclusionLaparoscopic vaginal suspension and rectopexy is a new combined procedure for the treatment of patients with rectal prolapses. It has excellent functional outcomes and minimal morbidity and can correct and prevent middlecompartment prolapses.

Long‐term functional outcome of colonic resections: how much does faecal impairment influence quality of life?

Older data suggest that colonic resection has a negative impact on continence and quality of life. The aim of this study was to evaluate the functional outcome of colonic resections for colonic cancer and diverticulitis and its influence on quality of life. Patients who underwent colonic resection between 2005 and 2013 were identified from a prospective database. A survey with two questionnaires [Faecal Incontinence Quality of Life (FIQL) scale, Short Form 12 (SF-12)] and additional questions concerning bowel function was sent to all patients. Colonic resection was performed in 362 patients in the study period; 297 patients returned the questionnaires (response rate 82.0%). Faecal urgency or incontinence more than once a month was present in 15% of patients and 25% of patients reported that bowel symptoms limited their quality of life. The mean total FIQL score for all patients was 3.58. The SF-12 score was comparable to a reference population without prior colonic resection. Patients after right-sided resections had liquid stool more often than others (45.3% vs 38.7%, P=0.011). No differences in bowel function and quality of life were detected between resections for colonic cancer and diverticulitis. Most patients experience no limitation in bowel function after segmental colectomy. Those with limitations in bowel function still seem to cope well, as the quality of life is not severely affected. Nevertheless, most patients with lower functional scores also had lower quality of life scores. Whether surgery is a relevant factor has to be questioned, as the prevalence of faecal incontinence in a comparable population without prior surgery is almost identical.

Quality of Life After a Low Anterior Resection for Rectal Cancer in Elderly Patients.

PurposeFecal incontinence is a major concern, and its incidence increases with age. Quality of life may decrease due to fecal incontinence after both sphincter-saving surgery and a rectal resection with a permanent stoma. This study investigated quality of life, with regard to fecal incontinency, in elderly patients after rectal-cancer surgery.MethodsAll patients who underwent elective rectal surgery with anastomosis for rectal cancer between December 2008 and June 2012 at two Dutch hospitals were eligible for inclusion. The Wexner and the fecal incontinence quality of life (FIQoL) scores were collected. Young (<70 years of age) and elderly (≥70 years of age) patients were compared.ResultsSeventy-nine patients were included, of whom 19 were elderly patients (24.1%). All diverting stomas that had been placed (n = 60, 75.9%) had been closed at the time of the study. There were no differences in Wexner or FIQoL scores between the young and the elderly patients. Also, there were no differences between patients without a diverting stoma and patients in whom bowel continuity had been restored. Elderly females had significantly worse scores on the FIQoL subscales of coping/behavior (P = 0.043) and depression/self-perception (P = 0.004) than young females. Elderly females scored worse on coping/behavior (P = 0.010) and depression/self-perception (P = 0.036) than elderly males. Young and elderly males had comparable scores.ConclusionQuality of life with regard to fecal incontinency is worse in elderly females after sphincter-preserving surgery for rectal cancer. Patients should be informed of this impact, and a definite stoma may be considered in this patient group.

A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study

The transobturator posterior anal sling (TOPAS) system is a posterior anal sling that is a minimally invasive, self-fixating polypropylene mesh intended to treat fecal incontinence (FI) in women who have failed conservative therapy. We are reporting 1-year outcome in a prospective, multicenter study under investigational device exemption, evaluating this new treatment modality. A total of 152 women were implanted with the TOPAS system at 14 centers in the United States. FI was assessed preoperatively and at the 12-month follow up with a 14-day bowel diary, Cleveland Clinic Incontinence Scores, and FI Quality of Life questionnaires. Treatment success was defined as reduction in number of FI episodes of ≥50% compared to baseline. Missing bowel diary data were considered treatment failures. The Wilcoxon signed rank test was used to compare changes observed at 12 months vs baseline. Mean age was 59.6 years old (SD 9.7). The mean duration of FI was 110 mo (range 8-712) months. Mean length of the implant procedure was 33.4 (SD 11.6) minutes. Mean EBL was 12.9 (SD 10.5) mL. Average follow-up was 24.9 months. At 12 months, 69.1% of patients met the criteria for treatment success, and 19% of subjects reported complete continence. FI episodes/wk decreased from a median of 9.0 (range 2-40) at baseline to 2.5 (range 0-40) (P < .001). FI days decreased from a median of 5.0 (range 1.5-7) at baseline to 2.0 (range 0-7) (P < .001) over a 7-day period. FI associated with urgency decreased from a median at baseline of 2.0 (range 0-26) to 0 (range 0-14.5) (P < .001). The mean Cleveland Clinic Incontinence Scores decreased from 13.9 at baseline to 9.6 at 12 months (P < .001). FI Quality of Life scores for all 4 domains improved significantly from baseline to 12 months (P < .001). A total of 66 subjects experienced 104 procedure- and/or device-related adverse events (AEs). Most AEs were short in duration and 97% were managed without therapy or with nonsurgical interventions. No treatment-related deaths, erosions, extrusions, or device revisions were reported. The most common AE categories were pelvic pain (n = 47) and infection (n = 26). Those subjects experiencing pelvic pain had a mean pain score (0-10 scale, 0 = no pain) during the 12-month follow-up of 1.2 (SD 2.4). The TOPAS system provides significant improvements in FI symptoms and quality of life with an acceptable AE profile and may therefore be a viable minimally invasive treatment option for FI in women.

PTU-246 Augmentation of a sphincter repair

Introduction Faecal incontinence (FI) affects between 1–10% of adults in varying degrees. Current epidemiological studies have shown that up to 1% of adults have regular episodes of faecal incontinence that adversely impacts their quality of life. A variety of synthetic and biological agents have been used for both overlapping sphincter repair (OSR) and as an anal bulking agent. The aim of this review is to provide an overview of the use of biological materials in the augmentation of the sphincter repair. Method A systematic search of PubMed was conducted using the search terms ‘anal bulking agents’, ‘anal sphincter repair’ or ‘overlapping sphincter repair’. Studies that utilised biological material for either sphincter repair or as a bulking agent were included. Overall, 5 studies were indentified for analysis after inclusion and exclusion criteria were applied. Results There were 3 studies with 127 patients of which 122 underwent anal bulking with a biological agent. 105 patients received a cross-linked porcine dermal collagen in the form of PermacolTM and a further 17 received Glutaraldehyde cross-linked (GAX) collagen, a highly purified bovine dermal collagen. Anorectal physiology was carried out in 27 patients and demonstrated deterioration in maximum resting pressure, and no significant change in maximum squeeze increment. Quality of life scores such as St Mark’s incontinence score, SF-36 and the Cleveland Clinic Florida Incontinence Score (CCFIS) demonstrated an improvement in scores at 6 weeks and 6 months, but this had deteriorated at 12 month follow up. There were no complications reported. 10 patients received a cross-linked porcine dermal collagen (PermacolTM) for OSR and 13 patients received porcine intestinal submucosa (Surgisis©) to carry out an anal encirclement procedure. Improvements in Faecal Incontinence Severity Index (FISI), CCFIS and two subscales of Faecal Incontinence Quality of Life (FIQL) (coping/behaviour and embarrassment) were observed in the group of patients undergoing OSR. Furthermore, the FISI, Wexner score and all components of FIQL score (lifestyle, coping/behaviour, depression and embarrassment) showed an improvement following anal encirclement using biological material. Incontinence episodes decreased to an average of one per week from 8 to 10 preoperatively and no complications were reported. Conclusion Sphincter augmentation with biological material has demonstrated significantimprovement in continence and quality of life scores in the short term compared to traditional repair. Long-term studies are necessary to determine if this effect is sustained. Disclosure of interest None Declared.

Biofeedback Therapy Before Ileostomy Closure in Patients Undergoing Sphincter-Saving Surgery for Rectal Cancer: A Pilot Study.

PurposeThis study prospectively investigated the effects of biofeedback therapy on objective anorectal function and subjective bowel function in patients after sphincter-saving surgery for rectal cancer.MethodsSixteen patients who underwent an ileostomy were randomized into two groups, one receiving conservative management with the Kegel maneuver and the other receiving active biofeedback before ileostomy closure. Among them, 12 patients (mean age, 57.5 years; range, 38 to 69 years; 6 patients in each group) completed the study. Conservative management included lifestyle modifications, Kegel exercises, and medication. Patients were evaluated at baseline and at 1, 3, 6, and 12 months after ileostomy closure by using anal manometry, modified Wexner Incontinence Scores (WISs), and fecal incontinence quality of life (FI-QoL) scores.ResultsBefore the ileostomy closure, the groups did not differ in baseline clinical characteristics or resting manometric parameters. After 12 months of follow-up, the biofeedback group demonstrated a statistically significant improvement in the mean maximum squeezing pressure (from 146.3 to 178.9, P = 0.002). However, no beneficial effect on the WIS was noted for biofeedback compared to conservative management alone. Overall, the FI-QoL scores were increased significantly in both groups after ileostomy closure (P = 0.006), but did not differ significantly between the two groups.ConclusionAlthough the biofeedback therapy group demonstrated a statistically significant improvement in the maximum squeezing pressure, significant improvements in the WISs and the FI-QoL scores over time were noted in both groups. The study was terminated early because no therapeutic benefit of biofeedback had been demonstrated.

Antegrade continence enema procedure: impact on quality of life in patients with spinal cord injury.

This is a prospective cohort study. Patients with spinal cord injury (SCI) often suffer from severe constipation/fecal incontinence. The antegrade continence enema (ACE) procedure is often used to control these distressing symptoms when medical management fails. Improvement in the quality of life (QOL) following the ACE procedure has been demonstrated in patients with fecal incontinence of various etiologies. We assess the impact of the ACE procedure on QOL in patients with fecal incontinence due to SCI. This study was conducted in the United States. We measured the impact of fecal incontinence on QOL in patients with SCI undergoing ACE using the validated fecal incontinence quality of life (FIQL) QOL instrument. The FIQL scores QOL in four domains: lifestyle, coping/behavior, depression/self-perception and embarrassment. Surveys were prospectively administered before and after surgery. Preoperative and postoperative survey scores were compared using two-sample T-test. Between 2003 and 2010, the ACE procedure was performed on 17 patients with SCI, including 10 paraplegic and seven quadriplegic patients with an average age of 33 years at the time of surgery. Scores in all four QOL realms assessed by the FIQL instrument improved significantly following the ACE procedure. Stomal stenosis requiring channel revision occurred in three patients and was the most common complication. This is the first study to our knowledge that assesses the impact of the ACE procedure on the QOL in patients with SCI. Using a validated questionnaire, we demonstrated significant improvement in QOL related to fecal incontinence following the ACE procedure in these patients who are severely affected by their bowel dysfunction.