Helen J. S. Jones

Summary: Aim: Fistula laser closure (FiLaC) is a minimally invasive treatment option for perianal fistulas with acceptable healing rates. We report implementation and include short-term results in line with the IDEAL (Idea, Development, Exploration, Assessment, Long-term study) 2A framework in patients with complex fistulas and previous surgical repair attempts. Method: Prospective audit data from 56 consecutive patients with perianal fistulas treated between June 2024 and January 2025. The FiLaC procedure included cleaning the fistula tract, application of approximately 100 J/cm fistula length and closing of the internal opening with a stitch. All patients refused more invasive operations and/or were not suitable for advanced repair. Results: Patients were diagnosed with fistulas after a median of 34.5 months (interquartile range, IQR 13.8–54.2 months), with a median of 3 months (IQR 1.8–4.0 months) following previous fistula-related surgery. Most patients had cryptoglandular fistulas (80.4%) while 19.6% had inflammatory bowel disease-related fistulas. Most fistulas were transsphincteric (69.6%), and only 32.1% of patients were seton-free before the procedure. During the first postprocedural outpatient visit at 7.9 weeks (median; IQR 6.4–10.9 weeks), clinical healing was evident in 14 (24.1%) cases, and 23 (39.7%) patients reported relevant symptomatic improvement. A total of 21 patients (36.2%) did not report any improvement, 3 patients (5.2%) experienced a postoperative complication, with 1 (1.7%) requiring a return to theatre due to an abscess. After a median of 10.4 months, the “seton-free rate” was 67.9%, This represents a relevant improvement to 32.1% before FiLaC. Conclusion: The use of FiLaC is a safe, sphincter-preserving treatment for complex perianal fistulas and was associated with a marked increase in the seton-free rate. While complete fistula healing rates were lower than previously reported, FiLaC remains an option for patients with complex disease.

Background: There is no consensus on optimal management of pilonidal disease. Surgical practice is varied, and existing literature is mainly single-centre cohort studies of varied disease severity, interventions and outcome assessments. Objectives: A prospective cohort study to determine: disease severity and intervention relationship most valued outcomes and treatment preference by patients recommendations for policy and future research. Design: Observational cohort study with nested mixed-methods case study. Discrete choice experiment. Clinician survey. Three-stage Delphi survey for patients and clinicians. Inter-rater reliability of classification system. Setting: Thirty-one National Health Service trusts. Participants: Patients aged > 16 years referred for elective surgical treatment of pilonidal disease. Interventions: Surgery. Main outcome measures: Pain postoperative days 1 and 7, time to healing and return to normal activities, complications, recurrence. Outcomes compared between major and minor procedures using regression modelling, propensity score-based approaches and augmented inverse probability weighting to account for measured potential confounding features. Results: Clinician survey: There was significant heterogeneity in surgeon practice preference. Limited training opportunities may impede efforts to improve practice. Cohort study: Over half of patients (60%; N = 667) had a major procedure. For these procedures, pain was greater on day 1 and day 7 (mean difference day 1 pain 1.58 points, 95% confidence interval 1.14 to 2.01 points, n = 536; mean difference day 7 pain 1.53 points, 95% confidence interval 1.12 to 1.95 points, n = 512). There were higher complication rates (adjusted risk difference 17.5%, 95% confidence interval 9.1 to 25.9%, n = 579), lower recurrence (adjusted risk difference −10.1%, 95% confidence interval −18.1 to −2.1%, n = 575), and longer time to healing (>34 days estimated difference) and time to return to normal activities (difference 25.9 days, 95% confidence interval 18.4 to 33.4 days). Mixed-methods analysis: Patient decision-making was influenced by prior experience of disease and anticipated recovery time. The burden involved in wound care and the gap between expected and actual time for recovery were the principal reasons given for decision regret. Discrete choice experiment: The strongest predictors of patient treatment choice were risk of infection/persistence (attribute importance 70%), and shorter recovery time (attribute importance 30%). Patients were willing to trade off these attributes. Those aged over 30 years had a higher risk tolerance (22.35–34.67%) for treatment failure if they could experience rapid recovery. There was no strong evidence that younger patients were willing to accept higher risk of treatment failure in exchange for a faster recovery. Patients were uniform in rejecting excision-and-leave-open because of the protracted nursing care it entailed. Wysocki classification analysis: There was acceptable inter-rater agreement (κ = 0.52, 95% confidence interval 0.42 to 0.61). Consensus exercise: Five research and practice priorities were identified. The top research priority was that a comparative trial should broadly group interventions. The top practice priority was that any interventions should be less disruptive than the disease itself. Limitations: Incomplete recruitment and follow-up data were an issue, particularly given the multiple interventions. Assumptions were made regarding risk adjustment. Conclusions and future work: Results suggest the burden of pilonidal surgery is greater than reported previously. This can be mitigated with better selection of intervention according to disease type and patient desired goals. Results indicate a framework for future higher-quality trials that stratify disease and utilise broad groupings of common interventions with development of a patient-centred core outcome set. Trial registration: This trial is registered as ISRCTN95551898. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/17/02) and is published in full in Health Technology Assessment; Vol. 28, No. 33. See the NIHR Funding and Awards website for further award information.

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.

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.

Aims: After local excision of early rectal cancer, definitive lymph node status is not available. An alternative means for accurate assessment of recurrence risk is required to determine the most appropriate subsequent management. Currently used measures are suboptimal. We assess three measures of tumour stromal content to determine their predictive value after local excision in a well‐characterised cohort of rectal cancer patients without prior radiotherapy.Methods and results: A total of 143 patients were included. Haematoxylin and eosin (H&E) sections were scanned for (i) deep neural network (DNN, a machine‐learning algorithm) tumour segmentation into compartments including desmoplastic stroma and inflamed stroma; and (ii) digital assessment of tumour stromal fraction (TSR) and optical DNA ploidy analysis. 3′ mRNA sequencing was performed to obtain gene expression data from which stromal and immune scores were calculated using the ESTIMATE method. Full results were available for 139 samples and compared with disease‐free survival. All three methods were prognostic. Most strongly predictive was a DNN‐determined ratio of desmoplastic to inflamed stroma >5.41 (P < 0.0001). A ratio of ESTIMATE stromal to immune score 36.5% (P = 0.037).Conclusions: The DNN‐determined ratio of desmoplastic to inflamed ratio is a novel and powerful predictor of disease recurrence in locally excised early rectal cancer. It can be assessed on a single H&E section, so could be applied in routine clinical practice to improve the prognostic information available to patients and clinicians to inform the decision concerning further management.

Aim The optimal management of a polyp cancer that has been removed endoscopically is unclear. Further local excision is often advocated to remove the polyp stalk or scar or to ensure clear margins, but the benefit of this is unclear. The aim of this paper is to determine whether the indications for further local excision can be better defined. Method Data were collected from two institutions (in UK and Denmark) which maintain prospective databases to collect information on all patients undergoing transanal endoscopic microsurgery (TEM). The study group was all patients who had a TEM after macroscopically complete polypectomy for rectal cancer. Data covering an 11-year period were analysed. RESULTS Sixty three patients had TEM with no residual cancer after macroscopically complete polypectomy. Residual adenoma was found in 23 (37%). A postpolypectomy endoscopy had not detected the residual adenoma in three. Malignant local recurrence occurred in five patients (8%) and distant metastases in another two (3%). Recurrence occurred in 4/23 (17%) when there was residual adenoma in the TEM specimen and in 3/40 (7.5%) where there was scar only, although this did not reach significance. In two instances recurrence was around 10 years after TEM. Those with residual adenoma at TEM tended to have poorer survival. Conclusion Further local excision often reveals no residual cancer despite microscopically involved polypectomy margins. Careful endoscopy is required to assess the polypectomy site as residual tumour can be missed. In the absence of residual adenoma, TEM does not appear to be of benefit, although a small risk of recurrence exists.

Purpose Neoadjuvant radiotherapy is commonly used in rectal cancer. When used prior to radical surgery in locally advanced disease, up to one-quarter of patients have no residual cancer at surgery suggesting that radical surgery was unnecessary; those with complete clinical response may be managed on a rectal-preserving ‘watch-and-wait’ pathway. In those receiving radiotherapy for early stage cancer, local excision of small volume residual or recurrent tumour is possible, but its value is unclear. Methods Data were collected from two institutions (UK and Denmark) which maintain prospective databases on all patients undergoing local excision by transanal endoscopic microsurgery (TEM). The study group was all patients who had TEM after neoadjuvant radiation for rectal cancer over an 11-year period. Results Forty-five patients had TEM after neoadjuvant radiation, 18 after short course radiotherapy (SCRT) and 27 after chemoradiotherapy (CRT). Local recurrence occurred in 13 (29%) and distant metastases in 11 (24%). Complete pathological response was noted in 10 (22%), 28% after SCRT and 19% after CRT, p = 0.02. However, local recurrence still occurred in 60% of those with ypT0 after SCRT. The recurrence rate may be higher in those with residual disease at TEM compared with complete responders (40 vs 30%). Conclusion If complete response can be determined clinically, local excision of the scar does not confer benefit, but follow-up should be maintained. If there is regrowth or residual tumour at TEM, further recurrence is common, and the benefits of TEM may not outweigh the risks, except in those unsuitable for radical surgery.

Aims and objectives: To report on the development, implementation and evaluation of the first year of the National Institute for Health Research 70@70 Senior Nurse Research Leader Programme.Background: Internationally, there is a lack of nursing and midwifery research and policy contribution to healthcare sectors. To address this, funding was obtained for a Senior Nurse and Midwife Research Leader Programme in England. The programme aimed to increase nursing and midwifery research capacity and capability and support the development of future research leaders.Design: The programme had three phases: development, implementation and evaluation. The cohort study's evaluation phase consisted of a survey and qualitative written feedback.Methods: An online survey was sent to cohort members (n = 66). Quantitative survey data was analysed in Survey Monkey. Written feedback asked cohort members to summarise their activities and any challenges. Data were thematically analysed. The “Strengthening the Reporting of Observational Studies in Epidemiology” reporting checklist was used.Results: Thirty‐nine (59%) cohort members responded to the survey. Responders valued being part of a network (46%), having protected time (22%) and having workplace autonomy (13%). Challenges reported included difficulties accessing online resources (32%), lack of collaborative opportunities (17%) and organisational barriers (10%). Fifty‐six (85%) cohort members submitted the written report. The main themes were “relationship and profile building”, “developing capability and capacity”, “developing the workforce”, “patient and public involvement and engagement” and “quality improvement.”Conclusions: The 70@70 programme has increased the research profile of the nursing and midwifery professions at a local and national level. International healthcare systems can learn from this, by considering optimal ways to provide nurses and midwives with the tools, resources and confidence to actively contribute to research policy and practice.Relevance to Clinical Practice: The initiatives undertaken through year 1 of the programme have created a platform through which research can be incorporated into clinical practice, education and teaching.