Prophylactic negative pressure wound therapy to improve wound healing rates following ileostomy closure: a randomized controlled trial.

BACKGROUND: Reversal of ileostomy is associated with morbidity including wound infection and prolonged wound healing. Negative pressure wound therapy (NPWT) has been shown to reduce time to wound healing by secondary intention. The aim of this study was to determine whether NPWT improved wound healing rates, compared with simple wound dressings, in patients undergoing reversal of ileostomy where the skin wound is closed with a purse-string suture. METHODS: This was a dual-centre, open-label, randomized controlled trial with two parallel intervention arms. Patients undergoing elective loop ileostomy reversal were randomized 1:1 to receive NPWT or simple wound dressings. The primary endpoint of the study was assessment of complete wound healing at day 42 post reversal of ileostomy and the secondary endpoints were patient-reported wound cosmesis using a visual analogue scale and rates of surgical site infection (SSI). RESULTS: The study was conducted from June 2018 to December 2021. The trial was approved by the local ethics committee. We enrolled 40 patients, 20 in each arm. One patient in each arm was lost to follow up. Nine patients (9/19, 47.36%) in the simple dressing group had wound healing vs. 13 patients (13/19, 68.42%) in the NPWT group (P = 0.188). There was no significant difference in patient- reported wound cosmesis or SSI. CONCLUSION: There was no difference in wound healing rates when comparing NPWT to simple wound dressings at early and late time points post reversal of ileostomy, where the skin wound was closed with a purse-string suture.

Pyridostigmine in chronic intestinal pseudo-obstruction - a systematic review.

BACKGROUND: Chronic intestinal pseudo-obstruction (CIPO) may be a primary or secondary phenomenon and is often multifactorial. Treatment is largely directed at improving colonic motility. The use of cholinesterase inhibitors such as pyridostigmine has been hypothesized to increase acetylcholine in the bowel, improving symptoms and transit times. METHODS: A systematic review of the use of pyridostigmine in CIPO was conducted using scientific and commercial search engines identifying scientific studies enrolling adult human subjects, published from 2000 to 2022 in the English language. RESULTS: Four studies were identified including two randomized controlled trials (RCT) and two observational studies. The studies had heterogenous inclusion criteria, dosing regimens and reported outcomes. Two studies were identified as being at high risk of bias. All studies reported improved patient outcomes with use of pyridostigmine, and low rates (4.3%) of mild cholinergic side effects. No major side effects were reported. CONCLUSION: The use of pyridostigmine in management of CIPO is biologically plausible due to its ability to increase colonic motility, and early studies on its role are uniformly suggestive of benefit with low side-effect profile. Four clinical studies have been conducted to date, with small sample sizes, heterogeneity and high risk of bias. Further high-quality studies are required to enable assessment of pyridostigmine's utility as an effective management strategy in CIPO.

Prospective randomised controlled trial of adults with perianal fistulising Crohn's disease and optimised therapeutic infliximab levels: PROACTIVE trial study protocol.

INTRODUCTION: Perianal fistulising Crohn's disease (pfCD) can be somewhat treatment refractory. Higher infliximab trough levels (TLIs) may improve fistula healing rates; however, it remains unclear whether escalating infliximab therapy to meet higher TLI targets using proactive, or routine, therapeutic drug monitoring (TDM) improves outcomes. This randomised controlled trial aimed to assess whether infliximab therapy targeting higher TLIs guided by proactive TDM improves outcomes compared with standard therapy. METHODS AND ANALYSIS: Patients with active pfCD will be randomised 1:1 to either the proactive TDM arm or standard dosing arm and followed up for 54 weeks. Patients in the proactive TDM arm will have infliximab dosing optimised to target higher TLIs. The targets will be TLI ≥ 25 µg/mL at week 2, ≥ 20 µg/mL at week 6 and ≥ 10 µg/mL during maintenance therapy. The primary objective will be fistula healing at week 32. Secondary objectives will include fistula healing, fistula closure, radiological fistula healing, patient-reported outcomes and economic costs up to 54 weeks. Patients in the standard dosing arm will receive conventional infliximab dosing not guided by TLIs (5 mg/kg at weeks 0, 2 and 6, and 5 mg/kg 8 weekly thereafter). Patients aged 18-80 years with pfCD with single or multiple externally draining complex perianal fistulas who are relatively naïve to infliximab treatment will be included. Patients with diverting ileostomies or colostomies and pregnant or breast feeding will be excluded. Fifty-eight patients per arm will be required to detect a 25% difference in the primary outcome measure, with 138 patients needed to account for an estimated 6.1% primary non-response rate and 10% dropout rate. ETHICS AND DISSEMINATION: Results will be presented in peer-reviewed journals and international conferences. Ethics approval has been granted by the South Western Sydney Local Health District Human Research Ethics Committee in Australia. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000023853); Pre-results.

Long-term outcomes of perianal fistulizing Crohn's disease in the biologic era.

BACKGROUND AND AIM: While the advent of biologic therapy has led to improved outcomes in perianal fistulizing Crohn's disease (pfCD), loss of response is common. Previous studies suggest that patients who achieve radiological healing (with healing of underlying tracts on magnetic resonance imaging [MRI]) have a longer duration of response. The aim of this study was to characterize MRI outcomes of pfCD at a specialist inflammatory bowel disease (IBD) unit and compare the long-term clinical outcomes between patients achieving MRI and clinical healing. METHODS: A retrospective analysis of perianal fistulizing Crohn's patients treated at one specialist IBD unit was performed. Records were reviewed for patient demographics, disease history, clinical assessments, investigation results, and disease flares. Clinical remission was defined as closure of all baseline fistula openings. Radiological healing was defined as the absence of any T2-hyperintense sinuses, tracts, or collections. The primary end-point was rate of MRI healing. The secondary outcome was defined as flare-free period (time between clinical or radiological healing and patients' first signs/symptoms requiring therapy escalation). RESULTS: A total of 93 patients were included, with a median follow-up of 4.8 years (interquartile range, 2.4-6 years). Of 44 patients, 22 (50%) achieved clinical remission, while 15 of 93 (16%) achieved radiological healing. Of 22 patients, 10 (45%) with clinical remission had a subsequent disease flare (median time of 7 months) compared with 3 of 15 (20%) patients with MRI healing (median time of 3.6 years). Radiological healing was associated with a significantly longer flare-free period (P = 0.01). CONCLUSION: Radiological healing occurs less commonly but represents a deeper form of healing, associated with improved long-term clinical outcomes.

Determinants of long-term function and general well-being in patients with an ileoanal pouch.

BACKGROUND AND AIM: Fecal incontinence and/or evacuation difficulty are common after ileoanal pouch surgery. This study aimed to determine whether the development of these symptoms can be predicted so that preventive measures might be instituted. METHODS: A consecutive series of 46 patients with ulcerative colitis (median age at surgery, 41 years; 50% female) and a functioning pouch for a duration ≥12 months was included. Assessment utilized medical record review and questionnaires on pre- and postoperative bowel function, quality of life, and psychological well-being. Pouch function was assessed by the Colorectal Functional Outcome score (0 = no impairment, 100 = worst impairment). Good pouch function was defined as a score ≤24. RESULTS: Fecal incontinence occurred in 67% preoperatively and 54% postoperatively; evacuation difficulty occurred in 65% and preoperatively and 85% postoperatively. The postoperative median Colorectal Functional Outcome score was 20 (range 2-74), with 44% of patients >24 (poor pouch function). Preoperative nocturnal fecal incontinence (odds ratio [OR] 4.92, 95% confidence interval [CI] 1.2-19.4, P = 0.02) and pouchitis (OR 5.41, 95% CI 1.2-23.7, P = 0.02) were associated with poor pouch function after multivariable regression analysis. Postoperative satisfaction, psychological well-being, and quality of life were significantly better in those with good pouch function, while poor sleep, impaired work, and sexual dysfunction were independently associated with poor pouch function. CONCLUSIONS: Functional bowel symptoms are common before and after pouch surgery and are associated with the impairment of patient-reported outcomes. Preoperative nocturnal fecal incontinence predicts poor pouch function. Therapeutic focus on continence, bowel evacuation, psychological well-being, and quality of life should begin before surgery.

Clinical utilization of magnetic resonance enterography in small bowel Crohn's disease management: a retrospective tertiary centre experience.

BACKGROUND: Magnetic resonance enterography (MRE) is the mainstay imaging modality in the evaluation of small bowel Crohn's disease (CD) activity and its associated complications. Few studies have assessed the indications for ordering it and its association with management changes. The objective was to identify the current clinical utilization of MRE and associated management changes in patients with established small bowel CD. METHODS: A retrospective audit was conducted on all patients with established CD who underwent MRE at a tertiary centre from November 2014 to December 2017. Clinical indications, radiological findings and management changes were obtained from patient records. RESULTS: A total of 220 patients underwent a total of 287 MRE examinations. The most common indications for ordering MREs were based on patient symptoms (n = 204, 71.1%) and routine disease surveillance (n = 57, 19.9%). The most common radiological findings were inflammation (n = 156, 54.4%) and strictures (n = 98, 34.1%). Management changes post MRE occurred in 152 of 287 (53%) cases. Of the 152 patients, 87 (57.2%) had changes in medical management, 40 (26.3%) had surgical or endoscopic intervention and 25 (16.4%) had both medical and surgical management changes. Management changes following MRE in patients with new or concerning symptoms were significantly higher than in surveillance patients (OR 4.1, P = 0.000003). CONCLUSION: This study provides a foundation for understanding the current utilization of MRE in small bowel CD at a tertiary centre. However, its role in altering management particularly within surveillance patients is yet to be defined. Future prospective trials are required to better delineate its role and develop an algorithm for small bowel CD management.

The Effect of Formalin Fixation on Resection Margins in Colorectal Cancer.

Resection margins in colorectal cancer carry clinical significance with regard to disease recurrence risk and selection for multimodal adjuvant therapy, especially with circumferential resection margins in rectal cancer. Colorectal cancer specimens are routinely fixed in formalin, which results in specimen and tumor-free margin shrinkage. However, the effects of shrinkage have not traditionally been taken into account when analyzing tumor-free margins. In this prospective study, 46 colorectal cancer specimens were measured in the fresh state and subsequently after formalin fixation for total specimen length, distal resection margin, and radial margin (circumferential resection margin for rectal cancer). The mean reduction after formalin fixation was 17.48 mm (14.7%) for distal resection margin and 1.20 mm (10.5%) for radial margin. For rectal cancer, circumferential resection margin reduction was 0.88 mm (11.8%); this was not affected by neoadjuvant chemoradiotherapy. Duration of formalin fixation did not significantly affect the extent of margin shrinkage. This is the first study to evaluate the effect of formalin fixation on radial resection margins, specifically as it relates to rectal cancer, and it demonstrates that shrinkage from formalin fixation should be a consideration in decision-making where the magnitude of tumor-free margins is small.

Three-point stapled fixation technique to manage ileostomy spout retraction.

This paper details a technique to manage non-fixed stomal retraction using a using a non-cutting linear stapler.

Three-Dimensional Modeling for Crohn's Fistula-in-Ano: A Novel, Interactive Approach.

BACKGROUND: Pelvic MRI allows for clear delineation of anatomy in Crohn's fistula-in-ano, although its interpretation is often difficult for nonradiologists. OBJECTIVE: The aim was to develop a 3-dimensional model where fistula tracts and their relationship to the sphincter complex can be accurately defined, which can then be rotated in multiple axes by the surgeon. DESIGN: A 3-dimensional model was created based on MRI images. An additional 3-dimensional T2-weighted sequence was added to the existing MRI protocol to obtain high-resolution images. Segmentation of the fistula tract and volume rendering of the segmented tract were performed to create the final model. SETTINGS: This was a single-center study conducted in Victoria, Australia. PATIENTS: All of the patients who had pelvic MRI for fistulating Crohn's disease between March 2016 and March 2017 had the additional MRI sequence. INTERVENTIONS: Postprocessing of MRI images was performed by a single radiologist. RESULTS: Total acquisition time for MRI images was extended to 31 minutes compared with the standard 2-dimensional protocol lasting 25 minutes. Additional postprocessing time used to create the model was ≈15 minutes. Two clinical vignettes using this model are presented and compared with conventional 2-dimensional MRI images to highlight the use of the 3-dimensional modeling technique. LIMITATIONS: This technique involves a semiautomatic process of fistula tract segmentation that requires radiologist expertise and additional postprocessing time. CONCLUSIONS: This 3-dimensional modeling technique enables accurate identification of tracts in Crohn's fistula-in-ano and improves spatial orientation for the surgeon. The model has the potential to be an invaluable preoperative tool to guide operative decision-making, as well as enabling the assessment of response to medical or surgical therapy.

Patients' perspective on bowel resection for inflammatory bowel disease.

PURPOSE: The study aimed to determine whether patients are receiving adequate counselling about elective bowel resection and timely surgery for inflammatory bowel disease (IBD). METHODS: Patients with IBD who underwent an elective bowel resection in a tertiary referral centre between April 2012 and Dec 2014 were identified from a prospective database. Patients under the age of 16 years were excluded from the study. Patients were contacted over the phone to complete a questionnaire regarding their perspective on their surgery, including the consultations that took place, preparedness and timing of surgery, as well as patient attitude towards bowel resection and satisfaction with post-operative outcomes. Demographic details were recorded. RESULTS: Thirty-one patients participated in the study. Twenty-one (68%) patients were diagnosed with Crohn's disease, nine (29%) were diagnosed with ulcerative colitis, and one (3%) had indeterminate colitis. Twenty-seven (87%) patients reported that the timing of the initial consultation regarding the option of bowel resection was appropriate. Twenty-five (81%) patients felt prepared after a consultation with the surgical team with regard to perioperative issues and potential complications. Fourteen (45%) patients reported that the timing of bowel resection was appropriate, while 15 (48%) reported that it should have been earlier. A significant improvement in patient's pre- and post-operative attitudes towards bowel resection was demonstrated (p = 0.004). Thirty (97%) patients were either happy or very happy with their results and symptom improvement post-bowel resection. CONCLUSION: Most patients are receiving adequate counselling about elective bowel resection for IBD, although there is room for improvement for preoperative education and optimising timing of surgery.

SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial.

BACKGROUND: Colorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects may last for many years and adversely affect QoL, and they may not be adequately addressed by standard specialist-based follow-up. Optimal management of these effects should harness the expertise of both primary care and specialist care. Shared models of care (involving both the patient's primary care physician [PCP] and specialist) have the potential to better support survivors and enhance health system efficiency. METHODS/DESIGN: SCORE (Shared care of Colorectal cancer survivors) is a multisite randomised controlled trial designed to optimise and operationalise a shared care model for survivors of CRC, to evaluate the acceptability of the intervention and study processes, and to collect preliminary data regarding the effects of shared care compared with usual care on a range of patient-reported outcomes. The primary outcome is QoL measured using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes are satisfaction with care, unmet needs, continuity of care and health resource use. The shared care model involves replacement of two routine specialist follow-up visits with PCP visits, as well as the provision of a tailored survivorship care plan and a survivorship booklet and DVD for CRC survivors. All consenting patients will be randomised 1:1 to either shared care or usual care and will complete questionnaires at three time points over a 12-month period (baseline and at 6 and 12 months). Health care resource use data will also be collected and used to evaluate costs. DISCUSSION: The evaluation and implementation of models of care that are responsive to the holistic needs of cancer survivors while reducing the burden on acute care settings is an international priority. Shared care between specialists and PCPs has the potential to enhance patient care and outcomes for CRC survivors while offering improvements in health care resource efficiency. If the findings of the present study show that the shared care intervention is acceptable and feasible for CRC survivors, the intervention may be readily expanded to other groups of cancer survivors. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000004369p . Registered on 3 January 2017; protocol version 4 approved 24 February 2017.

Endoscopic balloon dilatation of Crohn's strictures: a safe method to defer surgery in selective cases.

BACKGROUND: Endoscopic balloon dilatation (EBD) provides a valuable alternative to surgery for strictures in Crohn's disease (CD). Data are lacking regarding the factors that improve the safety and effectiveness of EBD in CD. The aim of this study is to determine the safety and efficacy of EBD and the clinical variables, which are predictive of successful treatment of CD strictures with EBD. METHODS: The records of all patients with CD in whom EBD was attempted between 2008 and 2013 were reviewed. Procedures were conducted at a single tertiary referral centre using a Boston Scientific CRE® TTS balloon. Technical success was defined as the ability to traverse the stricture with the endoscope and clinical success as the resolution of obstructive symptoms at review. RESULTS: Forty-seven patients with a total of 58 strictures (19 primary and 39 anastomotic strictures) were treated with EBD with median follow-up of 37 months. A total of 161 dilatation procedures were performed, with technical success reported in 139/158 (88%) cases and clinical success reported in 105/137 (76.7%) cases with complete data. Complications occurred in 7/161 dilatations (4.3% dilatations, 15% patients), three patients with perforation, one with acute bleeding and three admitted with abdominal pain. Eighteen of the 47 patients required surgery (38%). Strictures of <50 mm (P = 0.04) and those dilated to a diameter of ≥15 mm (P = 0.031) were less likely to require surgical resection. CONCLUSIONS: EBD is safe for both primary and post-surgical strictures. Stricture length and diameter of dilatation are predictive of success. In selected patients, treatment with EBD may reduce or delay the need for surgery.

Effect of intestinal resection on quality of life in Crohn's disease.

INTRODUCTION: Patients with Crohn's disease have poorer health-related quality of life [HRQoL] than healthy individuals, even when in remission. Although HRQoL improves in patients who achieve drug-induced or surgically induced remission, the effects of surgery overall have not been well characterised. METHODS: In a randomised trial, patients undergoing intestinal resection of all macroscopically diseased bowel were treated with postoperative drug therapy to prevent disease recurrence. All patients were followed prospectively for 18 months. C-reactive protein [CRP], Crohn's Disease Activity Index [CDAI], and faecal calprotectin [FC] were measured preoperatively and at 6, 12, and 18 months. HRQoL was assessed with a general [SF36] and disease-specific [IBDQ] questionnaires at the same time points. RESULTS: A total of 174 patients were included. HRQoL was poor preoperatively but improved significantly [p < 0.001] at 6 months postoperatively. This improvement was sustained at 18 months. Females and smokers had a poorer HRQoL when compared with males and non-smokers, respectively. Persistent endoscopic remission, intensification of drug treatment at 6 months, and anti-tumour necrosis factor therapy were not associated with HRQoL outcomes different from those when these factors were not present. There was a significant inverse correlation between CDAI, [but not endoscopic recurrence, CRP, or FC] on HRQoL. CONCLUSION: Intestinal resection of all macroscopic Crohn's disease in patients treated with postoperative prophylactic drug therapy is associated with significant and sustained improvement in HRQoL irrespective of type of drug treatment or endoscopic recurrence. HRQoL is lower in female patients and smokers. A higher CDAI, but not direct measures of active disease or type of drug therapy, is associated with a lower HRQoL.

Measurement of fecal calprotectin improves monitoring and detection of recurrence of Crohn's disease after surgery.

BACKGROUND & AIMS: Crohn's disease (CD) usually recurs after intestinal resection; postoperative endoscopic monitoring and tailored treatment can reduce the chance of recurrence. We investigated whether monitoring levels of fecal calprotectin (FC) can substitute for endoscopic analysis of the mucosa. METHODS: We analyzed data collected from 135 participants in a prospective, randomized, controlled trial, performed at 17 hospitals in Australia and 1 hospital in New Zealand, that assessed the ability of endoscopic evaluations and step-up treatment to prevent CD recurrence after surgery. Levels of FC, serum levels of C-reactive protein (CRP), and Crohn's disease activity index (CDAI) scores were measured before surgery and then at 6, 12, and 18 months after resection of all macroscopic Crohn's disease. Ileocolonoscopies were performed at 6 months after surgery in 90 patients and at 18 months after surgery in all patients. RESULTS: Levels of FC were measured in 319 samples from 135 patients. The median FC level decreased from 1347 µg/g before surgery to 166 µg/g at 6 months after surgery, but was higher in patients with disease recurrence (based on endoscopic analysis; Rutgeerts score, ≥i2) than in patients in remission (275 vs 72 µg/g, respectively; P < .001). Combined 6- and 18-month levels of FC correlated with the presence (r = 0.42; P < .001) and severity (r = 0.44; P < .001) of CD recurrence, but the CRP level and CDAI score did not. Levels of FC greater than 100 µg/g indicated endoscopic recurrence with 89% sensitivity and 58% specificity, and a negative predictive value (NPV) of 91%; this means that colonoscopy could have been avoided in 47% of patients. Six months after surgery, FC levels less than 51 µg/g in patients in endoscopic remission predicted maintenance of remission (NPV, 79%). In patients with endoscopic recurrence at 6 months who stepped-up treatment, FC levels decreased from 324 µg/g at 6 months to 180 µg/g at 12 months and 109 µg/g at 18 months. CONCLUSIONS: In this analysis of data from a prospective clinical trial, FC measurement has sufficient sensitivity and NPV values to monitor for CD recurrence after intestinal resection. Its predictive value might be used to identify patients most likely to relapse. After treatment for recurrence, the FC level can be used to monitor response to treatment. It predicts which patients will have disease recurrence with greater accuracy than CRP level or CDAI score.