Real-world practice and outcomes in pilonidal surgery: Pilonidal Sinus Treatment Studying The Options (PITSTOP) cohort.

BACKGROUND: Numerous surgical approaches exist for the treatment of pilonidal disease. Current literature on treatment is of poor quality, limiting the ability to define optimal intervention. The aim of this study was to provide real-world data on current surgical practice and report patient and risk-adjusted outcomes, informing future trial design. METHODS: This UK-wide multicentre prospective cohort study, including patients (aged over 16 years) who had definitive treatment for symptomatic pilonidal disease, was conducted between May 2019 and March 2022. Patient and disease characteristics, and intervention details were analysed. Data on patient-reported outcomes, including pain, complications, treatment failure, wound issues, and quality of life, were gathered at various time points up to 6 months after surgery. Strategies were implemented to adjust for risk influencing different treatment choices and outcomes. RESULTS: Of the 667 participants consenting, 574 (86.1%) were followed up to the study end. Twelve interventions were observed. Broadly, 59.5% underwent major excisional surgery and 40.5% minimally invasive surgery. Complications occurred in 45.1% of the cohort. Those who had minimally invasive procedures had better quality of life and, after risk adjustment, less pain (score on day 1: mean difference 1.58, 95% c.i. 1.14 to 2.01), fewer complications (difference 17.5 (95% c.i. 9.1 to 25.9)%), more rapid return to normal activities (mean difference 25.9 (18.4 to 33.4) days) but a rate of higher treatment failure (difference 9.6 (95% c.i. 17.3 to 1.9)%). At study end, 25% reported an unhealed wound and 10% had not returned to normal activities. CONCLUSION: The burden after surgery for pilonidal disease is high and treatment failure is common. Minimally invasive techniques may improve outcomes at the expense of a 10% higher risk of treatment failure.

Classification and stratification in pilonidal sinus disease: findings from the PITSTOP cohort.

AIM: Research in pilonidal disease faces several challenges, one of which is consistent and useful disease classification. The International Pilonidal Society (IPS) proposed a four-part classification in 2017. The aim of this work was to assess the validity and reliability of this tool using data from the PITSTOP cohort study. METHOD: Face validity was assessed by mapping the items/domains in the IPS tool against tools identified through a systematic review. Key concepts were defined as those appearing in more than two-thirds of published tools. Concurrent and predictive validity were assessed by comparing key patient-reported outcome measures between groups at baseline and at clinic visit. The outcomes of interest were health utility, Cardiff Wound Impact Questionnaire (CWIQ) and pain score between groups. Significance was set at p = 0.05 a priori. Interrater reliability was assessed using images captured during the PITSTOP cohort. Ninety images were assessed by six raters (two experts, two general surgeons and two trainees), and classified into IPS type. Interrater reliability was assessed using the unweighted kappa and unweighted Gwet's AC1 statistics. RESULTS: For face validity items represented in the IPS were common to other classification systems. Concurrent and predictive validity assessment showed differences in health utility and pain between groups at baseline, and for some treatment groups at follow-up. Assessors agreed the same classification in 38% of participants [chance-corrected kappa 0.52 (95% CI 0.42-0.61), Gwet's AC1 0.63 (95% CI 0.56-0.69)]. CONCLUSION: The IPS classification demonstrates key aspects of reliability and validity that would support its implementation.

Research and practice priorities in pilonidal sinus disease: a consensus from the PITSTOP study.

AIM: Pilonidal sinus disease is a common condition treated by colorectal surgeons. There is a lack of literature in the field to guide optimal management of this condition. As part of the PITSTOP study, we aimed to identify policy and research priorities to provide direction to the field. METHOD: Patients and surgeons were invited to participate. A 'So what, now what' exercise was conducted, informed by data from PITSTOP. This generated statements for research and practice priorities. A three-round online Delphi study was conducted, ranking statements based on policy and research separately. Statements were rated 1 (not important) to 9 (important). Statements that were rated 7-9 by more than 70% of participants were entered into the consensus meeting. Personalized voting feedback was shown between rounds. A face-to-face meeting was held to discuss statements, and participants were asked to rank statements using a weighted choice vote. RESULTS: Twenty-two people participated in the focus group, generating 14 research and 19 policy statements. Statements were voted on by 56 participants in round 1, 53 in round 2 and 51 in round 3. A total of 15 policy statements and 19 research statements were discussed in the consensus round. Key policy statements addressed treatment strategies and intensity, surgeon training opportunities, need for classification and the impact of treatment on return to work. Research recommendations included design of future trials, methodology considerations and research questions. CONCLUSION: This study has identified research and policy priorities in pilonidal sinus disease which are relevant to patients and clinicians. These should inform practice and future research.

A survey of treatment preferences of UK surgeons in the treatment of pilonidal sinus disease.

AIM: Pilonidal sinus is a common surgical condition which impacts a young and economically active population. There are limited data to guide treatment in this condition. The aim of this work was to assess current practice. METHOD: A survey was developed as part of the PITSTOP study. It included questions on volume of practice, treatment preferences and training. The survey was delivered to consultant surgeons with a UK practice through social media, specialty surgical societies and through PITSTOP sites. Descriptive statistics were reported. RESULTS: Of the 200 people who received a link to the questionnaire, 109 completed it (response rate 54.5%). Respondents treated a median of 15 patients per year, with 20% of these having recurrent disease. Estimates of recurrence were higher than reported in the literature and higher than in a survey 10 years ago. Nearly 50% of surgeons advocate nonsurgical treatment in some patients despite limited evidence. Two thirds practised interventions not favoured by guidelines, including excision and leave open and midline closure techniques. Invasive procedures tended to be favoured when minimally invasive procedures may be appropriate. Surgical training programmes were the key training setting for commonly offered procedures, with few other training opportunities reported. For some procedures, no formal training had been given. CONCLUSION: This survey highlights issues with quality in pilonidal surgery in the UK, with persistence of potentially outdated techniques, no consistent treatment escalation plan, a suggestion of under- or overtreatment of disease and a high perception of failure. This may relate to the current system of training and lack of evidence-based guidance.

Is early bowel resection better than medical therapy for ileocolonic Crohn's disease? A systematic review and meta-analysis.

AIM: There is emerging evidence supporting early bowel resection (EBR) for ileocaecal Crohn's disease (CD) as an alternative to conventional escalation of medical therapy (MT). Here, we present a systematic review and meta-analysis of studies comparing the outcomes of EBR with those of MT in ileocolonic CD, with a focus on ileocaecal disease. METHODOLOGY: The MEDLINE, Embase, CINAHL and Cochrane Central Register of Controlled Trials databases were searched for studies reporting the outcomes of EBR versus MT for ileocolonic CD. The Cochrane tools for assessment of risk of bias were used to assess the methodological quality of studies. RESULTS: Nine records (from 8 studies, with a total of 1867 patients) were included in the analysis. Six studies were observational and two were randomised controlled trials. There was a reduced need for drug therapy in the EBR arm. The rate of intestinal resection at 5 years was 7.8% in the EBR arm and 25.4% in the MT group with a pooled OR of 0.32 (95% CI 0.19, 0.54; p < 0.0001). The EBR group had a longer resection-free survival (HR 0.56, 95% CI 0.38, 0.83; p = 0.004). These outcomes were consistent in a subgroup analysis of patients with ileocaecal disease. Morbidity and quality of life scores were similar across the two groups. CONCLUSION: EBR is associated with a more stable remission compared to initial MT for ileocolonic Crohn's disease. There is enough evidence to support EBR as an alternative to escalation of MT in selected patients with limited ileocaecal disease.

Surgeon preference for treatment allocation in older people facing major gastrointestinal surgery: an application of the discrete choice experiment methodology.

AIM: Variation in major gastrointestinal surgery rates in the older population suggests heterogeneity in surgical management. A higher prevalence of comorbidities, frailty and cognitive impairments in the older population may account for some variation. The aim of this study was to determine surgeon preference for major surgery versus conservative management in hypothetical patient scenarios based on key attributes. METHOD: A survey was designed according to the discrete choice methodology guided by a separate qualitative study. Questions were designed to test for associations between key attributes (age, comorbidity, urgency of presentation, pathology, functional and cognitive status) and treatment preference for major gastrointestinal surgery versus conservative management. The survey consisting of 18 hypothetical scenarios was disseminated electronically to UK gastrointestinal surgeons. Binomial logistic regression was used to identify associations between the attributes and treatment preference. RESULTS: In total, 103 responses were received after 256 visits to the questionnaire site (response rate 40.2%). Participants answered 1847 out of the 1854 scenarios (99.6%). There was a preference for major surgery in 1112/1847 (60.2%) of all scenarios. Severe comorbidities (OR 0.001, 95% CI 0.000-0.030; P = 0.000), severe cognitive impairment (OR 0.001, 95% CI 0.000-0.033; P = 0.000) and age 85 years and above (OR 0.028, 95% CI 0.005-0.168; P = 0.000) were all significant in the decision not to offer major gastrointestinal surgery. CONCLUSION: This study has demonstrated variation in surgical treatment preference according to key attributes in hypothetical scenarios. The development of fitness-stratified guidelines may help to reduce variation in surgical practice in the older population.

The Association of Coloproctology of Great Britain and Ireland guideline on the management of anal fissure.

AIM: The management of anal fissure: ACPGBI position statement was written 15 years ago. [KLR Cross et al., Colorectal Dis, 2008]. Our aim was to update the guideline and provide recommendations on the most effective treatment for patients with anal fissures utilising a multidisciplinary, rigorous guideline methodology. METHODS: The development process consisted of six phases. In phase 1 we defined the scope of the guideline. The patient population included patients with acute and chronic anal fissure. The target group was all practitioners (primary and secondary care) treating patients with fissures and, in addition, healthcare workers and patients who desired information regarding fissure management. In phase 2 we formed a guideline development group (GDG) including a methodologist. In phase 3 review questions were formulated, using a reversed PICO process, starting with possible recommendations based on the GDG's knowledge. In phase 4 a comprehensive literature search focused on existing systematic reviews addressing each review question, supplemented by more recent studies if appropriate. In phase 5 data were extracted from the included papers and checked by the GDG. If indicated, meta-analysis of systematic review data was updated by the GDG. During phase 6 the GDG members decided what recommendations could be made based on the evidence in the literature and strength of the recommendation was assessed using 'grade'. RESULTS: This guideline is divided into two sections: Primary care which includes (i) diagnosis; (ii) basic treatment; (iii) topical treatment; and secondary care which includes (iv) botulinum toxin therapy; (v) surgical intervention and (vi) special situations (including pregnancy and breast-feeding patients, children, receptive anal intercourse and low-pressure fissures). A total of 23 recommendations were formulated. A new term clinically healed was described by the GDG. CONCLUSION: This guideline provides an up-to-date evidence-based summary of the current knowledge of the management of anal fissure and may serve as a useful guide for clinicians as well as a potential reference for patients.

Ileostomy for chronic constipation: a good idea or just asking for more trouble?

AIM: A defunctioning stoma may be an option for a small group of patients with chronic constipation who have exhausted all forms of conservative management and remain symptomatic. We investigated this group in terms of stoma-related complications and whether they regretted the intervention. METHODS: Patients presenting to Sheffield Teaching Hospitals Pelvic Floor Unit over a 7-year period with chronic constipation unresponsive to conservative management and who had undergone a loop ileostomy for management were interviewed using the decision regret scale. Details about subsequent stoma-related surgery were recorded. RESULTS: Thirty-seven of 38 female patients identified (median age 49 years, range 24-86) completed the decision regret scale. Median follow-up was 34 months (range 7-74). About half (49%) had no regret and a further 27% had minimal regret about the decision for a stoma. Fifty-five per cent of patients had further operations related to the stoma, some undergoing up to five operations. CONCLUSION: A small group of patients with intractable constipation may benefit from a loop ileostomy but are likely to need subsequent surgery to the stoma. Despite this most patients who have had a stoma do not regret the decision.

Survey to define informational needs of patients undergoing surgery for Crohn's anal fistula.

AIM: There are many surgical treatments used in Crohn's anal fistula, although none is perfect. Decisions about surgery in this condition may be preference sensitive. The aim of this study was to identify what information patients would like in order to make treatment decisions and to explore experiences of making decisions in this setting. METHOD: A survey was designed based upon qualitative interviews and input from patients and clinicians. It included a long list of informational items to be ranked on a scale of importance, a control preference scale, the decision regret scale, and items exploring preferred information formats. This was distributed through 10 English hospitals to patients with recent surgical treatment for Crohn's anal fistula. Results were analysed using principal component analysis, to identify key informational needs, and other appropriate descriptive statistics. RESULTS: In total 92 questionnaires were returned (response rate 41.8%); 48 (52.5%) respondents were women and 54 (58.7%) had undergone seton insertion. Principal component analysis identified three information needs: wound and aftercare, effect on perianal symptoms, severity of surgery. Decision-making preferences showed a desire to participate in decision-making. Median decision regret score was 25/100 (i.e., low). The preferred format for sharing information to support decision-making was from the surgeon, 80/92 (87.0%), and from a booklet, 58/92 (63.0%). CONCLUSION: Key informational needs in this condition are wound and after care, effect on perianal symptoms, and severity of surgery. Patients would like this information to help engage in shared decision-making.

Healthcare professional preferences in the health and fitness assessment and optimization of older patients facing colorectal cancer surgery.

AIM: There are few age- and fitness-specific, evidence-based guidelines for colorectal cancer surgery. The uptake of different assessment and optimization strategies is variable. The aim of this study was to explore healthcare professional opinion about these issues using a mixed methods design. METHODS: Semi-structured qualitative interviews were undertaken with healthcare professionals from a single UK region involved in the treatment, assessment and optimization of colorectal surgery patients. Interviews were analysed using the framework approach. An online questionnaire survey was subsequently designed and disseminated to UK surgeons to quantitatively assess the importance of interview themes. Descriptive statistics were used to analyse questionnaire data. RESULTS: Thirty-seven healthcare professionals out of 42 approached (response rate 88%) were interviewed across five hospitals in the south Yorkshire region. Three broad themes were developed: attitudes towards treatment of the older patient, methods of assessment of suitability and optimization strategies. The questionnaire was completed by 103 out of an estimated 256 surgeons (estimated response rate 40.2%). There was a difference in opinion regarding the role of major surgery in older patients, particularly when there is coexisting dementia. Assessment was not standardized. Access to optimization strategies was limited, particularly in the emergency setting. CONCLUSION: There is wide variation in the process of assessment and provision of optimization strategies in UK practice. Lack of evidence-based guidelines, cost and time constraints restrict the development of services and pathways. Differences in opinion between surgeons towards patients with frailty or dementia may account for some of the variation in colorectal cancer outcomes.

Protocol for a multi-centre observational and mixed methods pilot study to identify factors predictive of poor functional recovery after major gastrointestinal surgery and strategies to enhance uptake of perioperative optimization: Optimizing the care and treatment pathways for older patients facing major gastrointestinal surgery (OCTAGON).

INTRODUCTION: National datasets report large variations in outcomes from older people (≥65 years) between different UK surgical units. This implies that not all patients receive the same level of care or access to resources, such as rehabilitation or allied health professional input. This might impact functional decline. AIMS: Our aim is to evaluate the baseline status of older patients facing major gastrointestinal surgery and the impact of variation in perioperative assessment and provision of perioperative support on functional outcomes. Patients' experiences and views of assessment and optimization will be explored via integrated qualitative semi-structured interviews. METHODS AND ANALYSIS: This multi-centre, pilot cohort study will include patients ≥65 years presenting via both elective and emergency pathways at three to five South Yorkshire NHS hospitals (Clinical Trials registration NCT04545125). The primary outcome is functional recovery measured using the World Health Organization Disability Assessment Schedule 2.0 at 6 weeks post-operation. Secondary outcomes include feasibility, quality of life, length of stay and complication rate. An opportunistic sample size of 120 has been estimated and will inform the design of a future, adequately powered study. For the qualitative study, 20-30 semi-structured patient interviews will be undertaken with patients from the cohort study to explore experiences of assessment and optimization. Interviews will be digitally recorded, transcribed verbatim and analysed according to the framework approach. ETHICS AND DISSEMINATION: This study has been approved by the National Health Service Research Ethics Committee and is registered centrally with Health Research Authority. It has been adopted by the National Institute for Health Research Portfolio scheme. Dissemination will be via international and national surgical and geriatric conferences.

A systematic review of the quality of reporting of interventions in the surgical treatment of Crohn's anal fistula: an assessment using the TIDiER and Blencowe frameworks.

BACKGROUND: Crohn's anal fistula is a challenging condition, and may require multiple surgical procedures. To replicate successful procedures, these must be adequately reported in the literature. The aim of this study was to review the quality of reporting of components of surgical interventions for Crohn's anal fistula. METHODS: A systematic review was conducted. It was registered with PROSPERO (CRD:42019135157). The Medline and EMBASE databases were searched for studies reporting interventions intended to close fistula in patients with Crohn's disease, published between 1999 and August 2019. Abstracts and full texts were screened for inclusion by two reviewers. Dual extraction of data was performed to compare reporting to the TIDiER and Blencowe frameworks for reporting of interventions. RESULTS: Initial searches identified 207 unique studies; 38 full texts were screened for inclusion and 33 were included. The most common study design was retrospective cohort (17/33), and the most frequently reported interventions were anal fistula plug (n = 8) and fibrin glue (n = 6). No studies showed coverage of all domains of TIDieR. Reporting was poor among domains related to who provided an intervention, where it was provided, and how it was tailored. Reporting of domains in the Blencowe framework was poor; the majority of studies did not report the component steps of procedures or efforts to standardise them. CONCLUSIONS: This study demonstrates that reporting on technical aspects of interventions for Crohn's anal fistula is poor. Surgeons should aim to improve reporting to allow accurate reproduction of techniques both in clinical practice and in clinical trials.

Thirty years of the Association of Coloproctology of Great Britain and Ireland.

This is a summary of the history of the Association of Coloproctology of Great Britain and Ireland from its inception in the late 1980s to the present day.

Developing a core outcome set for fistulising perianal Crohn's disease.

OBJECTIVE: Lack of standardised outcomes hampers effective analysis and comparison of data when comparing treatments in fistulising perianal Crohn's disease (pCD). Development of a standardised set of outcomes would resolve these issues. This study provides the definitive core outcome set (COS) for fistulising pCD. DESIGN: Candidate outcomes were generated through a systematic review and patient interviews. Consensus was established via a three-round Delphi process using a 9-point Likert scale based on how important they felt it was in determining treatment success culminating in a final consensus meeting. Stakeholders were recruited nationally and grouped into three panels (surgeons and radiologists, gastroenterologists and IBD specialist nurses, and patients). Participants received feedback from their panel (in the second round) and all participants (in the third round) to allow refinement of their scores. RESULTS: A total of 295 outcomes were identified from systematic reviews and interviews that were categorised into 92 domains. 187 stakeholders (response rate 78.5%) prioritised 49 outcomes through a three-round Delphi study. The final consensus meeting of 41 experts and patients generated agreement on an eight domain COS. The COS comprised three patient-reported outcome domains (quality of life, incontinence and a combined score of patient priorities) and five clinician-reported outcome domains (perianal disease activity, development of new perianal abscess/sepsis, new/recurrent fistula, unplanned surgery and faecal diversion). CONCLUSION: A fistulising pCD COS has been produced by all key stakeholders. Application of the COS will reduce heterogeneity in outcome reporting, thereby facilitating more meaningful comparisons between treatments, data synthesis and ultimately benefit patient care.

A systematic review of non-invasive modalities used to identify women with anal incontinence symptoms after childbirth.

INTRODUCTION AND HYPOTHESIS: Anal incontinence following childbirth is prevalent and has a significant impact upon quality of life (QoL). Currently, there is no standard assessment for women after childbirth to identify these symptoms. This systematic review aimed to identify non-invasive modalities used to identify women with anal incontinence following childbirth and assess response and reporting rates of anal incontinence for these modalities. METHODS: Ovid Medline, Allied and Complementary Medicine Database (AMED), Cumulative Index of Nursing and Allied Health Literature (CINAHL), Cochrane Collaboration, EMBASE and Web of Science databases were searched for studies using non-invasive modalities published from January 1966 to May 2018 to identify women with anal incontinence following childbirth. Study data including type of modality, response rates and reported prevalence of anal incontinence were extracted and critically appraised. RESULTS: One hundred and nine studies were included from 1602 screened articles. Three types of non-invasive modalities were identified: validated questionnaires/symptom scales (n = 36 studies using 15 different instruments), non-validated questionnaires (n = 50 studies) and patient interviews (n = 23 studies). Mean response rates were 92% up to 6 weeks after childbirth. Non-personalised assessment modalities (validated and non-validated questionnaires) were associated with reporting of higher rates of anal incontinence compared with patient interview at all periods of follow-up after childbirth, which was statistically significant between 6 weeks and 1 year after childbirth (p < 0.05). CONCLUSIONS: This systematic review confirms that questionnaires can be used effectively after childbirth to identify women with anal incontinence. Given the methodological limitations associated with non-validated questionnaires, assessing all women following childbirth for pelvic-floor symptomatology, including anal incontinence, using validated questionnaires should be considered.