Patient-reported outcome measures in oncology: a qualitative study of the healthcare professional's perspective.

BACKGROUND: In the last decades, the number of cancer survivors has increased significantly due to improved treatment and better detection of recurrence. This increased survival redirects the scope from survival towards optimising functional outcomes and improving health-related quality of life (HRQol). Functional and HRQoL outcomes can be assessed with patient-reported outcome measures (PROMs). However, the use of PROMs in daily oncological care is not common. This qualitative study investigates the barriers and facilitators of PROM use in an oncological setting, from the perspective of the healthcare professionals (HCPs). METHODS: Individual semi-structured interviews were conducted among Dutch oncological HCPs. Barriers and facilitators of PROM implementation were identified on various levels of the healthcare system (i.e. level of the patient, individual professional, medical team, and healthcare organisation). Interviews were audio recorded and transcribed verbatim. Transcripts were manually analysed by two independent reviewers using a thematic approach. Identified barriers and facilitators were categorised into Grol and Wensing's framework for changing healthcare practice. RESULTS: Nineteen oncological HCPs working in academic and non-academic hospitals were interviewed. Barriers for PROM implementation were lack of good IT support, lack of knowledge on how to use PROMs, lack of time to complete and interpret PROMs, and a high administrative burden. PROM implementation can be facilitated by providing clear guidance regarding PROM interpretation, evidence that PROMs can save time, and stimulating multidisciplinary teamwork. CONCLUSION: From a HCP point of view, adequately functioning IT technology, sufficient knowledge on PROMs, and dedicated time during the consultation are essential for successful implementation of PROMs in oncological care. Additional local context-specific factors need to be thoroughly addressed.

Heterogeneity in outcome selection, definition and measurement in studies assessing the treatment of cryptoglandular anal fistula: findings from a systematic review.

BACKGROUND: Treatment for cryptoglandular anal fistula (AF) is challenging and a lack of uniform outcomes in the literature prevents direct comparison of treatments. This can be addressed by developing a core outcome set, a standardised set of outcomes reported in all interventional studies for a specific condition. The aim of this systematic review is to assess the range of outcomes, their definitions, and the measurement instruments currently utilised in interventional studies for adult patients with AF. This will inform the development of an AF core outcome set. METHODS: Medline, Embase and The Cochrane Library were searched to identify all patient- and clinician-reported outcomes in studies assessing medical, surgical or combination treatment of adult patients with AF published from January 2008 to May 2020. The resulting outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to better understand their distribution. RESULTS: In total, 155 studies were included, 552 outcomes were extracted, with a median of three outcomes (interquartile range 2-5) per study. Only 25% of studies demonstrated high-quality outcome reporting. The outcomes were merged into 52 unique outcomes and structured into four core areas and 14 domains, with the majority in the domain of physiological or clinical (gastrointestinal) outcomes. The most commonly reported outcomes were healing (77%), incontinence (63%), and recurrence (40%), with no single outcome assessed across all studies. There was a wide variation in outcome definitions and measurement instruments used. CONCLUSIONS: There is substantial heterogeneity in outcomes, definitions, and measurement instruments reported in interventional studies for cryptoglandular anal fistula. This emphasises the need for standardised outcome reporting and measurement.

The effect of the number of active electrode poles during tined lead placement on long-term efficacy of sacral neuromodulation in patients with faecal incontinence.

AIM: There is an ongoing debate as to whether or not the efficacy of sacral neuromodulation (SNM) is optimized by maximizing the total number of active electrode poles (AEPs) during lead placement because there are more programming options. However, this is at the cost of increased operating time. The aims of this study were to establish if a higher number of AEPs improves SNM efficacy during the trial period and after permanent implantable pulse generator (IPG) placement and if there is there a correlation between number of AEPs and battery life of the first placed IPG. METHOD: This was a single centre retrospective cohort study of new patients with faecal incontinence who underwent SNM between 2000 and 2018. Exclusion criteria were sphincter defect > 30%, rectocele/enterocele Grade 3 or higher and incomplete records. RESULTS: In all, 288/456 (63%) patients (women 91%; mean age 58.5 ± 11.7 years) were eligible for analysis. The number of AEPs during lead placement was two (n = 42, 14.5%), three (n = 82, 28.5%) and four (n = 164, 57%). There was no association between the number of AEPs during tined lead placement and long-term efficacy. Neither the success rate of the trial phase nor the battery life after first placed IPG was influenced by the number of AEPs. CONCLUSION: In this study, the number of AEPs does not seem to influence long-term efficacy of SNM success rate during the trial phase or the battery life of the first placed IPG. However, we also suggest that at the very least there should be two AEPs at lead placement.

European Society of ColoProctology: guideline for haemorrhoidal disease.

AIM: The goal of this European Society of ColoProctology project was to establish a multidisciplinary, international guideline for haemorrhoidal disease (HD) and to provide guidance on the most effective (surgical) treatment for patients with HD. METHODS: The development process consisted of six phases. In phase one we defined the scope of the guideline. The patient population included patients with all stages of haemorrhoids. The target group for the guideline was all practitioners treating patients with haemorrhoids and, in addition, healthcare workers and patients who desired information regarding the treatment management of HD. The guideline needed to address both the diagnosis of and the therapeutic modalities for HD. Phase two consisted of the compilation of the guideline development group (GDG). All clinical members needed to have affinity with the diagnosis and treatment of haemorrhoids. Further, attention was paid to the geographical distribution of the clinicians. Each GDG member identified at least one patient in their country who could read English to comment on the draft guideline. In phase three review questions were formulated, using a reversed process, starting with possible recommendations based on the GDG's knowledge. In phase four a literature search was performed in MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews. The search was focused on existing systematic reviews addressing each review question, supplemented by other studies published after the time frame covered by the systematic reviews. In phase five data of the included papers were extracted by the surgical resident (RT) and checked by the methodologist (JK) and the GDG. If needed, meta-analysis of the systematic reviews was updated by the surgical resident and the methodologist using Review Manager. During phase six the GDG members decided what recommendations could be made based on the evidence found in the literature using GRADE. RESULTS: There were six sections: (i) symptoms, diagnosis and classification; (ii) basic treatment; (iii) outpatient procedures; (iv) surgical interventions; (v) special situations; (vi) other surgical techniques. Thirty-four recommendations were formulated. CONCLUSION: This international, multidisciplinary guideline provides an up to date and evidence based summary of the current knowledge of the management of HD and may serve as a useful guide for patients and clinicians.

Longitudinal associations of light-intensity physical activity with quality of life, functioning and fatigue after colorectal cancer.

PURPOSE: Evidence from cross-sectional studies suggests that higher levels of light-intensity physical activity (LPA) are associated with better health-related quality of life (HRQoL) in colorectal cancer (CRC) survivors. However, these associations have not been investigated in longitudinal studies that provide the opportunity to analyse how within-individual changes in LPA affect HRQoL. We investigated longitudinal associations of LPA with HRQoL outcomes in CRC survivors, from 6 weeks to 2 years post-treatment. METHODS: Data were used of a prospective cohort study among 325 stage I-III CRC survivors (67% men, mean age: 67 years), recruited between 2012 and 2016. Validated questionnaires were used to assess hours/week of LPA (SQUASH) and HRQoL outcomes (EORTC QLQ-C30, Checklist Individual Strength) at 6 weeks, and 6, 12 and 24 months post-treatment. We applied linear mixed regression to analyse longitudinal confounder-adjusted associations of LPA with HRQoL. RESULTS: We observed statistically significant longitudinal associations between more LPA and better global quality of life and physical, role and social functioning, and less fatigue over time. Intra-individual analysis showed that within-person increases in LPA (per 8 h/week) were related to improved HRQoL, including better global quality of life (ß = 1.67, 95% CI 0.71; 2.63; total range scale: 0-100) and less fatigue (ß = - 1.22, 95% CI - 2.37; - 0.07; scale: 20-140). Stratified analyses indicated stronger associations among participants below the median of moderate-to-vigorous physical activity (MVPA) at diagnosis. CONCLUSION: Higher levels of LPA were longitudinally associated with better HRQoL and less fatigue in CRC survivors up to two years post-treatment. Further prospective studies using accelerometer data are necessary to inform development of interventions targeting LPA.

European Society of Coloproctology Core Outcome Set for haemorrhoidal disease: an international Delphi study among healthcare professionals.

AIM: There is considerable heterogeneity in outcomes in studies reporting on the treatment of haemorrhoidal disease (HD). The aim of this study was to develop a Core Outcome Set (COS) for HD in cooperation with the European Society of Coloproctology. METHOD: A Delphi study was performed according to the Outcome Measures in Rheumatology (OMERACT) methodology. In total 38 healthcare professionals and 30 patients were invited to the panel. Previously, 10 outcome domains and 59 outcomes were identified through a systematic literature review. In this study, these domains and outcomes were formed into one questionnaire for healthcare professionals and a separate questionnaire for patients. Sequential questionnaire rounds prioritizing the domains and outcomes were conducted. Panel members were asked to rate the appropriateness of each domain and outcome on a nine-point Likert scale. During a face-to-face meeting, healthcare professionals agreed on the primary and secondary end-points of the COS for HD. Finally, a short survey was sent to the healthcare professionals in order to reach consensus on how the chosen end-points should be assessed and at which time points. RESULTS: The response rate in questionnaire round 1 for healthcare professionals was 44.7% (n = 17). Sixteen out of 17 healthcare professionals also completed the questionnaire in round 2. The response rate for the patient questionnaire was 60% (n = 18). Seventeen healthcare professionals participated in the face-to-face meeting. The questionnaire rounds did not result in a clear-cut selection of primary and secondary end-points. Most domains and outcomes were considered important, and only three outcomes were excluded. During the face-to-face meeting, agreement was reached to select the domain 'symptoms' as primary end-point, and 'complications', 'recurrence' and 'patient satisfaction' as secondary end-points in the COS for HD. Furthermore, consensus was reached that the domain 'symptoms' should be a patient reported outcome measure and should include the outcomes 'pain' and 'prolapse', 'itching', 'soiling' and 'blood loss'. The domain 'complications' should include the outcomes 'incontinence', 'abscess', 'urinary retention', 'anal stenosis' and 'fistula'. Consensus was reached to use 'reappearance of initial symptoms' as reported by the patient to define recurrence. During an additional short survey, consensus was reached that 'incontinence' should be assessed by the Wexner Fecal Incontinence Score, 'abscess' by physical examination, 'urinary retention' by ultrasonography, 'anal stenosis' by physical examination, and 'fistula' by physical examination and MR imaging if inconclusive. During follow-up, the outcome 'symptoms' should be assessed at baseline, 7 days, 6 weeks and 1 year post-procedure. The outcomes 'abscess' and 'urinary retention' should be assessed 7 days post-procedure and 'incontinence', 'anal stenosis' and 'fistula' 1 year post-procedure. CONCLUSIONS: We developed the first European Society of Coloproctology COS for HD based on an international Delphi study among healthcare professionals. The next step is to incorporate the patients' perspective in the COS. Use of this COS may improve the quality and uniformity of future research and enhance the analysis of evidence.

Long-term outcomes of a Malone antegrade continence enema (MACE) for the treatment of fecal incontinence or constipation in adults.

PURPOSE: The aim of the study was to assess the long-term outcome of a Malone antegrade continence enema (MACE) procedure for fecal incontinence or constipation in adults. METHODS: This retrospective single-center study assessed the long-term outcome and quality of life (QoL) of patients who underwent a MACE procedure between 2005 and 2014 at the Maastricht University Medical Centre. Success rate was quantified by using Malone's continence scale. Quality of life was assessed by validated questionnaires covering general quality of life (SF-36 and Karnofsky scale), current pain level (visual analog scale), fecal incontinence (Vaizey incontinence survey), or constipation (Cleveland Clinic Constipation Score). RESULTS: Based on patients' records, 22 out of 30 patients (73%; 95% CI 54-87%) were still using their MACE. Mean follow-up was 43 months (SD 25.9) since time of surgery. According to the Malone continence scale, the overall success rate was 37% (95% CI 20.0-53.3). Nine patients developed a postoperative complication. Eighteen out of 22 patients (13 with constipation and 5 with fecal incontinence) returned the QoL questionnaires (82% response rate). Long-term quality of life of patients with a MACE did not differ from the general Dutch population. CONCLUSIONS: In our cohort of patients with fecal incontinence or constipation, MACE resulted in a disappointed overall success rate of 37%. However, it may be indicated in patients who do not prefer more invasive surgical procedures or a definite stoma. The success and morbidity rate should be thoroughly discussed with the patients preoperatively.

Towards a core outcome set for hemorrhoidal disease-a systematic review of outcomes reported in literature.

PURPOSE: Previously published literature regarding treatment of hemorrhoidal disease (HD) revealed a lack of uniform defined outcomes. These differences between outcomes among studies limit transparency and lead to incomparability of results. The aim of this study was to systematically list the types of outcomes used in HD studies. This list will be used to develop a core outcome set. METHODS: We searched Medline (Pubmed), Embase (OVID), and Cochrane for interventional studies for adult patients with HD. Two authors independently identified and reviewed eligible studies. This resulted in a list of outcomes reported by each clinical trial. All outcomes were categorized using the conceptual framework OMERACT filter 2.0. RESULTS: A total of 34 randomized controlled trials and prospective observational studies were included in this study. A total of 59 different types of outcomes were identified. On average, 5.8 different outcomes (range 2-8) were used per study. The outcomes were structured into three core areas and10 ten domains. The most commonly reported core area was pathophysiological manifestations including the domain symptoms, complications, and recurrence. The most frequently reported outcomes were pain (91%), blood loss (94%), prolapse (71%), and incontinence (56%). There was a high variation in definitions of the common outcomes. And often there was no definition at all. CONCLUSION: This study shows a substantial heterogeneity in the types of outcomes in HD studies. We provided an overview of the types of outcomes reported in HD studies and identified a list of potentially relevant outcomes required for the development of a COS.

Sacral neuromodulation versus personalized conservative treatment in patients with idiopathic slow-transit constipation: study protocol of the No.2-trial, a multicenter open-label randomized controlled trial and cost-effectiveness analysis.

PURPOSE: The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. METHODS: This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Patients with obstructed outlet, irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, ß = 0.80, 30% difference in success). Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. Long-term costs and effectiveness will be estimated by a decision analytic model. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic. CONCLUSIONS: The results of this trial will be used to make a final decision regarding reimbursement of SNM from the Dutch Health Care Package in this patient group. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov , identifier NCT02961582, on 12 October 2016.

Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults.

AIM: Sacral neuromodulation (SNM) is a minimally invasive therapy for functional constipation (FC) and is most often used to treat adults. Recent studies suggest that SNM may also beneficial in children. However, comparative data regarding preferred age of SNM for FC are lacking. Therefore, long-term results of SNM for FC were compared between children and adults. METHOD: All patients treated with SNM for FC between 2004 and 2015 were evaluated. Outcomes of children (age 10-18 years) were compared with those for adults (≥ 18 years). The primary end-point was a defaecation frequency of three or more times per week, which is consistent with the ROME-III criteria. Secondary outcomes were quality of life (QoL; SF-36) and the Cleveland Clinic Constipation Score. RESULTS: One hundred and eighty patients (45 children, 135 adults) were eligible for SNM. The mean age was 15.8 (children) and 41.4 years (adults). One hundred and twenty-six patients received permanent SNM (38 children, 88 adults). Mean follow-up was 47 months in both groups. Defaecation frequency increased in both groups after SNM compared with baseline. Defaecation frequency in adults was higher than in children. The increased defaecation frequency was maintained during the entire follow-up period in both groups. QoL of children was impaired compared with the Dutch population with regard to bodily pain, general health and vitality. Adults had worse QoL with regard to physical functioning, bodily pain, general health, vitality and social functioning compared with the Dutch population. QoL of children did not differ from adults. CONCLUSION: Sacral neuromodulation (SNM) should be considered in children (< 18 years) with FC. However, the indication of SNM for FC remains debatable considering the limited improvements and high costs.

Dutch validation of the low anterior resection syndrome score.

AIM: The aim of this study was to validate the Dutch translation of the low anterior resection syndrome (LARS) score in a population of Dutch rectal cancer patients. METHOD: Patients who underwent surgery for rectal cancer received the LARS score questionnaire, a single quality of life (QoL) category question and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. A subgroup of patients received the LARS score twice to assess the test-retest reliability. RESULTS: A total of 165 patients were included in the analysis, identified in six Dutch centres. The response rate was 62.0%. The percentage of patients who reported 'major LARS' was 59.4%. There was a high proportion of patients with a perfect or moderate fit between the QoL category question and the LARS score, showing a good convergent validity. The LARS score was able to discriminate between patients with or without neoadjuvant radiotherapy (P = 0.003), between total and partial mesorectal excision (P = 0.008) and between age groups (P = 0.039). There was a statistically significant association between a higher LARS score and an impaired function on the global QoL subscale and the physical, role, emotional and social functioning subscales of the EORTC QLQ-C30 questionnaire. The test-retest reliability of the LARS score was good, with an interclass correlation coefficient of 0.79. CONCLUSION: The good psychometric properties of the Dutch version of the LARS score are comparable overall to the earlier validations in other countries. Therefore, the Dutch translation can be considered to be a valid tool for assessing LARS in Dutch rectal cancer patients.

Alternatives to antibiotics for prevention of surgical infection.

BACKGROUND: Surgical-site infection (SSI) is still the second most common healthcare-associated infection, after respiratory tract infection. SSIs are associated with higher morbidity and mortality rates, and result in enormous healthcare costs. In the past decade, several guidelines have been developed that aim to reduce the incidence of SSI. Unfortunately, there is no consensus amongst the guidelines, and some are already outdated. This review discusses the recent literature regarding alternatives to antibiotics for prevention of SSI. METHODS: A literature search of PubMed/MEDLINE was performed to retrieve data on the prevention of SSI. The focus was on literature published in the past decade. RESULTS: Prevention of SSI can be divided into preoperative, perioperative and postoperative measures. Preoperative measures consist of showering, surgical scrubbing and cleansing of the operation area with antiseptics. Perioperative factors can be subdivided as: environmental factors, such as surgical attire; patient-related factors, such as plasma glucose control; and surgical factors, such as the duration and invasiveness of surgery. Postoperative measures consist mainly of wound care. CONCLUSION: There is a general lack of evidence on the preventive effectiveness of perioperative measures to reduce the incidence of SSI. Most measures are based on common practice and perceived effectiveness. The lack of clinical evidence, together with the stability of the high incidence of SSI (10 per cent for colorectal procedures) in recent decades, highlights the need for future research.

Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence.

BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS: Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION: PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study.

PURPOSE: Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease. METHODS: A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS. DISCUSSION: Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.

Cost-effectiveness of sacral neuromodulation for chronic refractory constipation in children and adolescents: a Markov model analysis.

AIM: This study aimed to assess the cost-effectiveness of sacral neuromodulation (SNM) compared with conservative treatment in children and adolescents with constipation refractory to conservative management. METHOD: A Markov probabilistic model was used, comparing costs and effectiveness of SNM and conservative treatment in children and adolescents aged 10-18 years with constipation refractory to conservative management. Input for the model regarding transition probabilities, utilities and healthcare costs was based on data from a cohort of patients treated in our centre. This cohort consisted of 30 female patients (mean age 16 years) with functional constipation refractory to conservative management. The mean duration of laxative use in this group was 5.9 years. All patients had a test SNM, followed by a permanent SNM in 27/30. Median follow-up was 22.1 months (range 12.2-36.8). The model was run to simulate a follow-up period of 3 years. RESULTS: The mean cumulative costs for the SNM group and the conservative treatment group were €17 789 (SD €2492) and €7574 (SD €4332) per patient, respectively. The mean quality adjusted life years (QALYs) in the SNM group was 1.74 (SD 0.19), compared with 0.86 (SD 0.14) in the conservatively managed group. The mean incremental cost-effectiveness ratio was €12 328 per QALY (SD €4788). Sensitivity analysis showed that the outcomes were robust to a wide range of model assumptions. CONCLUSION: Chronic constipation seriously affects the quality of life of children and adolescents. Preliminary evidence suggests that SNM can improve symptoms and quality of life at a reasonable cost.

Systematic review and meta-analysis of surgical interventions for high cryptoglandular perianal fistula.

PURPOSE: Perianal fistulas, and specifically high perianal fistulas, remain a surgical treatment challenge. Many techniques have, and still are, being developed to improve outcome after surgery. A systematic review and meta-analysis was performed for surgical treatments for high cryptoglandular perianal fistulas. METHODS: Medline (Pubmed, Ovid), Embase and The Cochrane Library databases were searched for relevant randomized controlled trials on surgical treatments for high cryptoglandular perianal fistulas. Two independent reviewers selected articles for inclusion based on title, abstract and outcomes described. The main outcome measurement was the recurrence/healing rate. Secondary outcomes were continence status, quality of life and complications. RESULTS: The number of randomized trials available was low. Fourteen studies could be included in the review. A meta-analysis could only be performed for the mucosa advancement flap versus the fistula plug, and did not show a result in favour of either technique in recurrence or complication rate. The mucosa advancement flap was the most investigated technique, but did not show an advantage over any other technique. Other techniques identified in randomized studies were seton treatment, medicated seton treatment, fibrin glue, autologous stem cells, island flap anoplasty, rectal wall advancement flap, ligation of intersphincteric fistula tract, sphincter reconstruction, sphincter-preserving seton and techniques combined with antibiotics. None of these techniques seem superior to each other. CONCLUSIONS: The best surgical treatment for high cryptoglandular perianal fistulas could not be identified. More randomized controlled trials are needed to find the best treatment. The mucosa advancement flap is the most investigated technique available.

Long-term outcome of low perianal fistulas treated by fistulotomy: a multicenter study.

PURPOSE: Fistulotomy is considered to be the golden standard for the treatment of low perianal fistula but might have more influence on continence status than believed. This study was performed to evaluate the healing rate after a fistulotomy and to show results for continence status. METHODS: A retrospective database study was performed in one university medical center and its six affiliated hospitals. All patients treated with a fistulotomy for a low perianal fistula were identified. Healing and recurrence of the fistula were identified. Questionnaires on continence status and quality of life were mailed to all patients. RESULTS: In total, 537 patients were identified. The primary etiology of the fistulas was cryptoglandular (66.5%). Recurrence was seen in 88 patients (16.4%) resulting in a primary healing rate of 83.6%. After secondary treatment for the recurrence, another 40 patients healed. This resulted in a secondary healing rate of 90.3%. The Kaplan-Meier analysis showed that at 5 years, the healing rate was 0.81 (95% confidence interval (95% CI) 0.71-0.85). The mean Vaizey score was 4.67 (SD 4.80). Major incontinence, defined as a Vaizey score of >6, was seen in 95 (28.0%) patients. Only 26.3% of the patients had a perfect continence status (Vaizey score 0). Quality of life was not different from the general population. CONCLUSIONS: Fistulotomy seems to be associated with a healing rate of 0.81 (95% CI 0.71-0.85) after 5 years. However, major incontinence is still reported by 26.8% of patients and only 26.3% of patients had a perfect continence status.

Treatment of Crohn's disease-related high perianal fistulas combining the mucosa advancement flap with platelet-rich plasma: a pilot study.

BACKGROUND: Healing rates after surgical closure for high perianal fistula in patients with Crohn's disease are even more disappointing than in patients with cryptoglandular fistulas. The objective was to improve healing rates by combining the well-known mucosal advancement flap with platelet-rich plasma. METHODS: A prospective pilot study was conducted in one tertiary referral centre. Consecutive patients with primary or recurrent Crohn's disease-related high perianal fistulas, defined as involving the middle and/or upper third parts of the anal sphincter complex, were included. A staged procedure was performed with non-cutting seton treatment for 3 months first, followed by a mucosal advancement flap with injection of platelet-rich plasma into the fistula tract. RESULTS: Ten consecutive patients were operated on between 2009 and 2014. Half (50%) of the patients had undergone previous fistula surgery. Mean follow-up was 23.3 months (SD 13.0). Healing of the fistula was 70% (95% confidence interval, 33-89%) at 1 year. One (10%) patient had a recurrence, and in two (20%) patients, the fistula was persistent after treatment. An abscess occurred in one (10%) patient. The median post-operative Vaizey score was 8.0 (range 0-21), indicating a moderate to severe continence impairment. CONCLUSIONS: The results of combining the mucosal advancement flap with platelet-rich plasma in patients with Crohn's disease-related high perianal fistulas are moderate with a healing rate of 70%. Further investigation is needed to determine the benefits and risks on continence status for this technique in this patient population.

Rectovaginal fistula: a new technique and preliminary results using collagen matrix biomesh.

BACKGROUND: A rectovaginal fistula (RVF) is a debilitating condition that is difficult to treat. Many available techniques are invasive and involve extensive surgery. A local procedure with good closure rates would be preferable as a first step in the treatment of RVF. The aim of this study was the development of a local technique for the closure of RVF with good closure rates to prevent the use of more invasive procedures. METHODS: This was a pilot study. Patients with RVF who had undergone multiple operations in the pelvic area, local radiotherapy, chemotherapy or had been diagnosed with Crohn's disease were included in the study. All had a history of surgery for RVF. A cross-linked collagen matrix biomesh was placed in the rectovaginal septum using a transperineal or a transvaginal approach. The main outcome measure in this study was the closure rate reported as absence of the fistula at 1 year. RESULTS: Twelve patients were included in the study. Absence of fistula at 1 year was 0.64 (95 % confidence interval 0.30-0.85). Three patients (25.0 %) developed a recurrence, two were reoperated on with a gracilis flap transposition, and one was treated with laparoscopic ligation. In one patient (8.3 %), the fistula failed to close within 3 months after the mesh placement. CONCLUSIONS: Our technique shows promising results. A local and simple technique with acceptable closure and morbidity rates, like our local repair with biomesh, would be ideal as a first step in treating RVFs. Long-term results are needed.