Defecatory Function Studies Using the Fecobionics Device Are Repeatable.

BACKGROUND: Only limited data exist on repeatability of anorectal studies with the established physiological and clinical technologies for assessment of anorectal function. Fecobionics is a new multi-sensor simulated feces that provide data by integrating elements from current tests. AIMS: To study repeatability of anorectal data obtained with the Fecobionics device. METHODS: We assessed the database of Fecobionics studies to determine how many repeated studies were done. From a total of 260 Fecobionics studies, 19 subjects with repeated studies using approximately the same protocol and prototype were identified. Key pressure and bending parameters were assessed and the repeatability analyzed using Bland Altman plots. Furthermore, the inter- and intra-individual coefficient of variation (CV) were computed. RESULTS: Fifteen subjects (5F/10 M) with repeated studies were normal subjects, three were patients with fecal incontinence and one subject suffered from chronic constipation. The main analysis was conducted on the cohort of normal subjects. The bias for 11 parameters were within the confidence interval, whereas two were slightly outside. The interindividual CV was lowest for the bend angle (10.1-10.7) and between 16.3 and 51.6 for the pressure parameters. The intra-individual CVs were approximately half of the inter-individual CVs, spanning from 9.7 to 27.6. CONCLUSION: All data from normal subjects were within previously defined normality. The Fecobionics data showed acceptable repeatability with bias within the confidence limits for almost all parameters. The intra-individual CV was much lower than the inter-individual CV. Dedicated large-scale studies are warranted to evaluate the influence of age, sex, and disease on repeatability as well as comparing between technologies.

Fecobionics Characterization of Patients With Fecal Incontinence.

Fecal incontinence (FI) is characterized by involuntary loss of rectal content. Up to 9.5% of Americans younger than 70 years suffer from FI.1 The pathophysiology has many causes and is not well understood and diagnosed.

Simulated stool for assessment of anorectal physiology.

Fecal continence is maintained by several mechanisms including anatomical factors, anorectal sensation, rectal compliance, stool consistency, anal muscle strength, mobility, and psychological factors. The homeostatic balance is easily disturbed, resulting in symptoms including fecal incontinence and constipation. Current technologies for assessment of anorectal function have limitations. Overlap exist between data obtained in different patient groups, and there is lack of correlation between measurements and symptoms. This review describes a novel technology named Fecobionics for assessment of anorectal physiology. Fecobionics is a simulated stool, capable of dynamic measurements of a variety of variables during defecation in a single examination. The data facilitate novel analysis of defecatory function as well as providing the foundation for modeling studies of anorectal behavior. The advanced analysis can enhance our physiological understanding of defecation and future interdisciplinary research for unraveling defecatory function, anorectal sensory-motor disorders, and symptoms. This is a step in the direction of improved diagnosis of anorectal diseases.

Electroacupuncture-reduced sedative and analgesic requirements for diagnostic EUS: a prospective, randomized, double-blinded, sham-controlled study.

BACKGROUND AND AIMS: The role of electroacupuncture (EA) in reducing sedative and analgesic requirements during EUS is uncertain. The aim of this study was to investigate the efficacy of EA in reducing procedure-related pain and discomfort during EUS. METHODS: This was a double-blinded randomized controlled study conducted between March 2014 and July 2016. Consecutive patients who were scheduled for diagnostic EUS were recruited and randomized to receive EA or sham-electroacupuncture (SA). The primary outcome was the dosage of propofol used. Other outcome measurements included pain scores, anxiety scores, satisfaction scores, patients' willingness to repeat the procedure, total procedure time, and adverse events. RESULTS: A total of 128 patients were recruited to the study. The patients who received EA had significantly fewer requirements for patient-controlled sedation and analgesia (PCA). The median (interquartile range) number of demands for PCA (2 [1-5] vs 16.5 [8.5-33.8]; P < .001), the number of successful demands (2 [1-4] vs 9 [5.3-13]; P < .001), and the total dose of propofol (0.15 [0.08-0.34] vs 0.77 [0.38-1.09]; P < .001) and alfentanil (0.38 [0.20-0.86] vs 1.92 [0.94-2.72]; P < .001) were all significantly less. Patients who received EA also had significantly lower procedural pain scores and anxiety scores (P < .001), and higher satisfaction scores (P < .001), and they were more willing to repeat the procedure (P < .001). Being in the SA group and the procedure time were significant predictors of increased PCA demands (P < .001 and P = .009, respectively). CONCLUSIONS: In conclusion, the use of EA reduced sedative and analgesia demands, improved patient experience, and was associated with a low risk of adverse events during diagnostic EUS. (Clinical trial registration number: NCT02066194.).

Translation and validation of the traditional Chinese version of the faecal incontinence quality of life scale.

PURPOSE: Psychometric evaluation with tools such as the faecal incontinence quality of life scale is an essential component of clinical assessment. Currently, there is no translated Traditional Chinese version of the scale. A validated translated version may help to improve the quality of healthcare received in countries with Chinese minorities (0.5, 1.2 and 4.0% of the UK, USA and Australian population, respectively) as well as local population of Hong Kong. The purpose of this study is to validate the Traditional Chinese version of the faecal incontinence quality of life scale (FIQL). METHODS: The FIQL questionnaire was translated into Traditional Chinese Language followed by linguistic validation. It was then tested on 55 patients with faecal incontinence and 93 controls in the colorectal outpatients clinic. Faecal incontinence severity index was also used for the assessment of disease severity. RESULTS: Internal consistency was good/excellent for all scales (Cronbach's alpha >0.70, between 0.71 and 0.93). The intra-class correlation indicated a high stability over time with coefficients ranging between 0.78 and 0.90. Test and retest of all four scales found no significant differences of mean scores between baseline and retest. The mean faecal incontinence quality of life scale scores of all four domains improved significantly after treatment of 10 patients whose faecal incontinence severity index scores decreased by 50 % of their pre-treatment scores, hence indicating good sensitivity. CONCLUSIONS: This study demonstrates the linguistic and psychometric validity of the traditional Chinese version of the faecal incontinence quality of life scale.

Long-term oncologic outcomes of laparoscopic versus open surgery for rectal cancer: a pooled analysis of 3 randomized controlled trials.

OBJECTIVE: To compare long-term oncologic outcomes between laparoscopic and open surgery for rectal cancer and to identify independent predictors of survival. BACKGROUND: Few randomized trials comparing laparoscopic and open surgery for rectal cancer have reported long-term survival data. METHODS: Data from the 3 randomized controlled trials comparing curative laparoscopic (n=136) and open surgery (n=142) for upper, mid, and low rectal cancer conducted at the Prince of Wales Hospital, Hong Kong, between September 1993 and August 2007 were pooled together for this analysis. Survival and disease status were updated to February 2012. Survival was calculated using the Kaplan-Meier method, and independent predictors of survival were determined using the Cox regression analysis. RESULTS: The demographic data of the 2 groups were comparable. The median follow-up time of living patients was 124.5 months in the laparoscopic group and 136.6 months in the open group. At 10 years, there were no significant differences in locoregional recurrence (5.5% vs. 9.3%; P=0.296), cancer-specific survival (82.5% vs. 77.6%; P=0.443), and overall survival (63.0% vs. 61.1%; P=0.505) between the laparoscopic and open groups. There was a trend toward lower recurrence rate at 10 years in the laparoscopic group than in the open group among patients with stage III cancer (P=0.078). The Cox regression analysis showed that stage III cancer, lymphovascular permeation, and blood transfusion, but not the operative approach, were independent predictors of poorer cancer-specific survival. CONCLUSIONS: This pooled analysis with a follow-up of more than 10 years confirms the long-term oncologic safety of laparoscopic surgery for rectal cancer.

Electroacupuncture reduces duration of postoperative ileus after laparoscopic surgery for colorectal cancer.

BACKGROUND & AIMS: We investigated the efficacy of electroacupuncture in reducing the duration of postoperative ileus and hospital stay after laparoscopic surgery for colorectal cancer. METHODS: We performed a prospective study of 165 patients undergoing elective laparoscopic surgery for colonic and upper rectal cancer, enrolled from October 2008 to October 2010. Patients were assigned randomly to groups that received electroacupuncture (n = 55) or sham acupuncture (n = 55), once daily from postoperative days 1-4, or no acupuncture (n = 55). The acupoints Zusanli, Sanyinjiao, Hegu, and Zhigou were used. The primary outcome was time to defecation. Secondary outcomes included postoperative analgesic requirement, time to ambulation, and length of hospital stay. RESULTS: Patients who received electroacupuncture had a shorter time to defecation than patients who received no acupuncture (85.9 ± 36.1 vs 122.1 ± 53.5 h; P < .001) and length of hospital stay (6.5 ± 2.2 vs 8.5 ± 4.8 days; P = .007). Patients who received electroacupuncture also had a shorter time to defecation than patients who received sham acupuncture (85.9 ± 36.1 vs 107.5 ± 46.2 h; P = .007). Electroacupuncture was more effective than no or sham acupuncture in reducing postoperative analgesic requirement and time to ambulation. In multiple linear regression analysis, an absence of complications and electroacupuncture were associated with a shorter duration of postoperative ileus and hospital stay after the surgery. CONCLUSIONS: In a clinical trial, electroacupuncture reduced the duration of postoperative ileus, time to ambulation, and postoperative analgesic requirement, compared with no or sham acupuncture, after laparoscopic surgery for colorectal cancer. ClinicalTrials.gov number, NCT00464425.

Laparoscopic-assisted versus open total mesorectal excision with anal sphincter preservation for mid and low rectal cancer: a prospective, randomized trial.

BACKGROUND: This single-center, prospective, randomized trial was designed to compare the short-term clinical outcome between laparoscopic-assisted versus open total mesorectal excision (TME) with anal sphincter preservation (ASP) in patients with mid and low rectal cancer. Long-term morbidity and survival data also were recorded and compared between the two groups. METHODS: Between August 2001 and August 2007, 80 patients with mid and low rectal cancer were randomized to receive either laparoscopic-assisted (40 patients) or open (40 patients) TME with ASP. The median follow-up time for all patients was 75.7 (range 16.9-115.7) months for the laparoscopic-assisted group and 76.1 (range 4.7-126.6) months for the open group. The primary endpoint of the study was short-term clinical outcome. Secondary endpoints included long-term morbidity rate and survival. Data were analyzed by intention-to-treat principle. RESULTS: The demographic data of the two groups were comparable. Postoperative recovery was better after laparoscopic surgery, with less analgesic requirement (P < 0.001), earlier mobilization (P = 0.001), lower short-term morbidity rate (P = 0.043), and a trend towards shorter hospital stay (P = 0.071). The cumulative long-term morbidity rate also was lower in the laparoscopic-assisted group (P = 0.019). The oncologic clearance in terms of macroscopic quality of the TME specimen, circumferential resection margin involvement, and number of lymph nodes removed was similar between both groups. After curative resection, the probabilities of survival at 5 years of the laparoscopic-assisted and open groups were 85.9 and 91.3 %, respectively (P = 0.912). The respective probabilities of being disease-free were 83.3 and 74.5 % (P = 0.114). CONCLUSIONS: Laparoscopic-assisted TME with ASP improves postoperative recovery, reduces short-term and long-term morbidity rates, and seemingly does not jeopardize survival compared with open surgery for mid and low rectal cancer ( http://ClinicalTrials.gov Identifier: NCT00485316).

Consistency of Feces Affects Defecatory Function.

Background/Aims: It is a common belief that constipated patients have hard feces that contributes to the difficulties defecating. To the best of our knowledge, no studies had been published on controlled evacuation of simulated feces with different consistencies. Methods: Twelve normal subjects were recruited for studies with the simulated feces device "Fecobionics" of different consistency (silicone shore 0A-40A corresponding to Bristol Stool Form Scale types 2-4). The subjects filled out questionnaires and had the balloon expulsion test (BET) and anorectal manometry (ARM) done for reference. The Fecobionics probes were inserted in rectum in random order with +20 minutes between insertions. The bag was filled to urge-to-defecate and evacuations took place in privacy. Non-parametric statistics with median and quartiles are provided. Results: One subject was excluded due to technical issues, and another had abnormal ARM-BET. The 4 females/6 males subjects were 23yrs (range 20-48). Most differences were observed between the 0A and 10A probe (duration, maximum bag pressure, duration x maximum bag pressure, and relaxation of the front pressure and the bend angle during evacuation), eg, the duration was 9 (8-12) seconds at 0A and 18 (12-21) seconds at 10A (P < 0.05), and maximum bag pressure was 107 (96-116) at 0A and 140 (117-162) cmH2O at 10A (P < 0.05). The bend angle before evacuation differed between the probes whereas only the 10A differed from 40A during defecation. The 10A was harder to evacuate than the 0A probe. Except for the bend angles, no further significant change was observed from 10A to 40A. Conclusion: Fecal consistency affects defecatory parameters.

The rectum, anal sphincter and puborectalis muscle show different contraction wave forms during prolonged measurement with a simulated feces.

Contractile patterns in rectum, puborectalis muscle and anal sphincter must be studied to understand defecation. Six subjects had contractile waveforms studied with Fecobionics. Symptom questionnaires, balloon expulsion test and anorectal manometry were done for reference. The Fecobionics bag was filled in rectum to urge-to-defecate volume and measurements were done for 4 h before the subjects attempted to evacuate the device. Pressures and bend angle (BA) variations were analyzed with Fast Fourier Transformation. Four normal subjects exhibited low frequency waves (< 0.06 Hz) for pressures and BA. The waves were uncoordinated between recordings, except for rear and bag pressures. Peak wave amplitudes occurred at 0.02-0.04 Hz. Pressures and the BA differed for peak 1 (p < 0.001) and peak 2 amplitudes (p < 0.005). The front pressure amplitude was bigger than the others (rear and BA, p < 0.05; bag, p < 0.005) for peak 1, and bigger than bag pressure (p < 0.005) and BA (p < 0.05) for peak 2. One subject was considered constipated with lower front pressure amplitudes compared to normal subjects and increased amplitudes for other parameters. The sixth subject was hyperreactive and differed from the other subjects. In conclusion, the rectum, anal sphincter and puborectalis muscle showed different contraction waves during prolonged measurements. The data call for larger studies to better understand normal defecation, feces-withholding patterns, and the implications on anorectal disorders.

Detection of miR-92a and miR-21 in stool samples as potential screening biomarkers for colorectal cancer and polyps.

OBJECTIVE: The detection of molecular markers in stool samples is a potential strategy for colorectal cancer (CRC) screening. This study evaluated the feasibility of detecting miR-21 and miR-92a in stool samples of patients with CRC or polyps. METHODS: The reproducibility of detection and stability of stool-based microRNA were evaluated. Stool samples were collected from 88 patients with CRC, 57 patients with colorectal polyps and 101 healthy controls. MiRNA levels in CRC tissues and stool samples were detected by real-time quantitative reverse transcription PCR. Stool miR-21 and miR-92a levels were compared before and after the removal of tumour or advanced adenoma. RESULTS: The study demonstrated that stool-based miRNA were stable with highly reproducible detection. The expression of miR-21 and miR-92a was significantly higher in CRC tissues compared with their adjacent normal tissues (p<0.0001). Patients with CRC had a significantly higher stool miR-21 level (p<0.01) and miR-92a level (p<0.0001) compared with normal controls. Stool miR-92a, but not miR-21, was significantly higher in patients with polyps than in controls (p<0.0001). At a cut-off value of 435 copies/ng of stool RNA, miR-92a had a sensitivity of 71.6% and 56.1% for CRC and polyp, respectively, and a specificity of 73.3%. In addition, the stool miR-92a level demonstrated a higher sensitivity for distal CRC than proximal CRC (p<0.05), and a higher sensitivity for advanced adenoma than minor polyps (p<0.05). Removal of tumour resulted in reduced stool miR-21 and miR-92a levels (p<0.01), and the removal of advanced adenoma resulted in a reduction of the stool miR-92a level (p<0.05). CONCLUSION: Stool miRNA are useful for screening CRC and polyps.

The non-invasive diagnosis of colorectal cancer via a SOX9-based gene panel.

Colorectal cancer (CRC) threatens human health seriously. Early diagnosis of CRC is critical to improving patient survival. Meanwhile, non-invasive detection through tumor-circulating markers can be an important auxiliary diagnosis. In this study, we performed targeted RNA sequencing in paired tumor and adjacent normal fresh frozen tissues from 68 patients, and we also measured circulating mRNA levels in 4 time-point plasma samples collected before and after operation or chemotherapy. Our results showed that SOX9 (6.73-fold with adjusted p value < 1 × 10-45), MYC (20.59-fold with adjusted p value < 1 × 10-57), and MMP7 (131.94-fold with adjusted p value < 1 × 10-78) highly expressed in tumor compared with adjacent normal tissues. Besides, the circulating mRNA of SOX9 (41.14-fold with adjusted p value < 1 × 10-13) in CRC was significantly higher than in the normal control as well. Moreover, a SOX9-based 9-gene panel (SOX9, GSK3A, FZD4, LEF1, DVL1, FZD7, NFATC1, KRT19, and RUVBL1) showed the non-invasive diagnostic value of CRC (AUC: 0.863 (0.766-0.960), TPR: 0.92, TNR: 0.87). In summary, SOX9 expression consistently increases in tumor and plasma samples from CRC patients, which indicates the important role of SOX9 in CRC progression and its potential in non-invasive diagnosis of CRC.

The diagnostic significance of CDH17-positive circulating tumor cells in patients with colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) is the second leading cause of cancer deaths in Hong Kong. We tested the hypothesis that circulating tumor cell (CTC) analysis by ARB101 antibody could be used as a tool for CRC detection, progression, and therapy response. RESEARCH METHODS: ARB101 antibody was used for investigation of CDH17 expression in formalin-fixed, paraffin-embedded (FFPE) tissue sections and circulating tumor cells (CTCs) of CRC patients. RESULTS: Using ARB101, highest sensitivity was observed in 98/100 (98%) colorectal cancer tissue compared to 72/100 gastric cancer (72%) and 27/32 pancreatic cancer (84%). Immunoreactivity of CDH17 was significantly higher in distant metastatic (tumor-node-metastasis [TNM] stage IV) than non-distant metastatic (TNM stage I to III) CRC. ARB101 antibody also manifested the higher sensitivity than c-erbB2 (8%) and epidermal growth factor receptor (EGFR)-targeting antibodies (37%) with the significance (p < 0.0001). ARB101 positive CTCs were detected in 64/83 (77%) TNM stage I to IV CRC patients. Furthermore, ARB101 positive CTCs detected in TNM stage I to III CRC patients before and after surgical operation are statistically significant (p < 0.0001). CONCLUSIONS: CTC detection by ARB101 antibody could serve as a potential non-invasive approach for CRC detection, progression, and monitoring of treatment response.

Cell-free circulating tumor RNAs in plasma as the potential prognostic biomarkers in colorectal cancer.

Background: Cell free RNA (cfRNA) contains transcript fragments from multiple cell types, making it useful for cancer detection in clinical settings. However, the pathophysiological origins of cfRNAs in plasma from colorectal cancer (CRC) patients remain unclear. Methods: To identify the tissue-specific contributions of cfRNAs transcriptomic profile, we used a published single-cell transcriptomics profile to deconvolute cell type abundance among paired plasma samples from CRC patients who underwent tumor-ablative surgery. We further validated the differentially expressed cfRNAs in 5 pairs of CRC tumor samples and adjacent tissue samples as well as 3 additional CRC tumor samples using RNA-sequencing. Results: The transcriptomic component from intestinal secretory cells was significantly decreased in the in-house post-surgical cfRNA. The HPGD, PACS1, and TDP2 expression was consistent across cfRNA and tissue samples. Using the Cancer Genome Atlas (TCGA) CRC datasets, we were able to classify the patients into two groups with significantly different survival outcomes. Conclusions: The three-gene signature holds promise in applying minimal residual disease (MRD) testing, which involves profiling remnants of cancer cells after or during treatment. Biomarkers identified in the present study need to be validated in a larger cohort of samples in order to ascertain their possible use in early diagnosis of CRC.

Fecobionics characterization of female patients with fecal incontinence.

Defecatory disorders including fecal incontinence (FI) are diagnosed on the symptom pattern supplemented by anorectal manometry (ARM), the balloon expulsion test (BET), and endo-anal ultrasonography. In this study, we used a simulated stool named Fecobionics to study distinct defecation patterns in FI patients using preload-afterload diagrams and to provide comparative data on defecation indices (DIs) between passive and urge incontinent patients. All subjects had Fecobionics, endo-anal ultrasonography and ARM-BET done. The Fecobionics bag was distended in rectum until urge in 37 female patients (64.1 ± 1.5 yrs) and a group of normal subjects (NS, 12F, age 64.8 ± 2.8 yrs). Rear-front pressure (preload-afterload) diagrams and DIs were compared between groups. The FISI score in the patients was 8.6 ± 0.6. The NS did not report FI-related symptoms. All patients and NS defecated Fecobionics and ARM-BET within 2 min. The urge volume was 46.1 ± 3.6 and 35.3 ± 5.9 mL in the FI and normal groups (P > 0.1). The expulsion duration was 14.8 ± 2.4 and 19.8 ± 5.1 s for the two groups (P > 0.1). The preload-afterload diagrams demonstrated clockwise loops that clearly differed between the FI subtypes and NS. The DIs showed profound difference between patients and NS. Fecobionics data showed higher correlation with symptoms in FI patients than ARM-BET. Fecobionics obtained novel pressure signatures in subtypes of FI patients and NS. Fecobionics provides DI data that cannot be obtained with ARM-BET.

Fecobionics Evaluation of Biofeedback Therapy in Patients With Fecal Incontinence.

INTRODUCTION: Biofeedback therapy (BFT) is a well-known treatment for functional anorectal disorders. The effect of BFT was monitored in fecal incontinence (FI) patients with the Fecobionics test and with the conventional technologies, anorectal manometry (ARM) and balloon expulsion test (BET). METHODS: Studies were performed in 12 patients before and after 8 weeks of biofeedback training. The Fecal Incontinence Severity Index (FISI) score was obtained. Anal resting and squeeze pressures were measured before the bag was distended in the rectum until urge to defecate. Pressure recordings were made during Fecobionics evacuation. RESULTS: BFT resulted in 24% reduction in FISI scores (P < 0.01). Seven patients were characterized as responders. Anal pressures, the urge-to-defecate volume, and defecatory parameters did not change significantly during BFT. For ARM-BET, the maximum anal squeeze pressure, the urge-to-defecate volume, and the expulsion time were lower after BFT compared with those before BFT (P < 0.05). For Fecobionics, the change in urge volume (r = 0.74, P < 0.05) and the change in defecation index (r = 0.79, P < 0.01) were associated with the change in FISI score. None of the ARM-BET parameters were associated with the change in FISI score. It was studied whether any pre-BFT data could predict treatment success. The Fecobionics expulsion duration and the defecation index predicted the outcome (P < 0.05). The defecation index had a sensitivity of 100% and a specificity of 72%. None of the ARM-BET parameters predicted the outcome (all P > 0.2). DISCUSSION: Fecobionics was used as a tool to monitor the effect of BFT and proved better than conventional technologies for monitoring and predicting the outcome in the FISI score.

Functional anorectal studies in patients with low anterior resection syndrome.

BACKGROUND: Most patients who have undergone low anterior resection suffer from bowel dysfunction postoperatively. This condition is referred to as low anterior resection syndrome (LARS). The aim was to study defecatory patterns in LARS patients compared to a primary control group of fecal incontinence (FI) patients and normal subjects (NS) with the Fecobionics device. METHODS: Fecobionics expulsion parameters were assessed in an interventional study design. The Fecobionics probe contained pressure sensors at the front, rear, and inside the bag. The bag was distended until urge sensation in rectum in 11 LARS patients (5F/6M, 63.2 ± 2.9 years), 11 FI subjects (7F/4M, 64.4 ± 2.5 years), and 11 NS (7F/4M, 63.6 ± 3.0 years). Defecation indices were computed from the Fecobionics data. All subjects had high-resolution anorectal manometry (ARM) and balloon expulsion test (BET) done. Symptoms were evaluated with LARS and Wexner scores. KEY RESULTS: The LARS score in the LARS patients was 39.0 ± 0.6. The Wexner score in the LARS, FI, and NS groups was 14.2 ± 0.7, 10.1±1.0, and 0.0 ± 0.0 (p < 0.01). The resting anal pressure and squeeze pressure were lowest in LARS patients (p < 0.05). The urge volume was 11.8 ± 4.2, 59.6 ± 6.4, and 41.6 ± 6.4 ml in the LARS, FI, and NS groups, respectively (p < 0.001). The expulsion duration did not differ between groups. Defecation indices were lowest in the LARS patients (p < 0.05). ARM-BET confirmed the low urge volume in LARS patients whereas anal pressures did not differ between groups. CONCLUSIONS AND INFERENCES: The LARS patients had low anal pressures and urge volume. Most Defecation Indices differed between the LARS group and the other groups.

Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial.

BACKGROUND: Patients with colorectal cancer have a high risk of iron deficiency anaemia (IDA) due to chronic tumour induced blood loss, a reduced dietary iron intake from poor nutrition or gastrointestinal malabsorption. This pilot, double blinded, randomised controlled trial (RCT) examined the effect and feasibility of using preoperative iron isomaltoside for treating iron deficiency anaemia. METHODS: Forty eligible adults with IDA were randomised to receive either intravenous iron isomaltoside (20 mg.kg-1 up to 1000 mg over 30 minutes) or usual preoperative care (control) three weeks before scheduled colorectal surgery. The primary outcomes were perioperative changes in haemoglobin and ferritin concentrations. RESULTS: The recruitment rate was 78% of all eligible referred patients (1.9 patients/month). The haemoglobin and ferritin concentrations were higher in the iron isomaltoside group than the control group over the perioperative period (group*time interaction P = 0.042 and P < 0.001 respectively). Mean haemoglobin change from baseline to before surgery was higher in the iron isomaltoside group (7.8, 95% CI: 3.2 to 12.3 g.l-1) than the control group (1.7, 95% CI: -1.9 to 5.3 g.l-1) [mean difference 6.1, 95% CI: 0.3 to 11.8 g.l-1; P = 0.040]. The ferritin change from baseline to before surgery between groups was large in favour of the iron isomaltoside group (mean difference 296.9, 95% CI: 200.6 to 393.2 µg.l-1; P < 0.001]. There were no differences between groups in packed red blood cell transfusions needed, surgical complications, quality of recovery and days (alive and) at home within 30 days after surgery. CONCLUSION: Iron isomaltoside therapy was safe and had a minimal effect on perioperative changes in haemoglobin concentration. Given the slow recruitment and new evidence emerging during the conduct of this study, conducting a multi-centre RCT based on the current pilot trial protocol is unlikely to be feasible. TRIAL REGISTRATION: ClinicalTrials.gov NCT03565354.

Effect of a patient education video and prehabilitation on the quality of preoperative person-centred coordinated care experience: protocol for a randomised controlled trial.

INTRODUCTION: Multimodal prehabilitation, an emerging field within the Perioperative Medicine specialty, requires close multidisciplinary team coordination. The goal is to optimise the patient's health status in the 4-8 weeks before elective surgery to withstand surgical stress. Most patients are unfamiliar with the concept of prehabilitation but are interested in participating in such a programme after explanation. The objective of this randomised controlled trial is to evaluate the effect of prehabilitation (patient education video and multimodal prehabilitation) on the preoperative patient-centred coordinated care experience. METHOD AND ANALYSIS: One hundred patients undergoing major elective surgery (cardiac, colorectal, hepatobiliary-pancreatic and urology) will be recruited into a two-group, parallel, superiority, single-blinded randomised controlled trial. Patients will be randomised to receive either preoperative patient education comprising of a video and prehabilitation programme with standard care (intervention) or standard care (control). The primary outcome measure will be the quality of preoperative patient care experience using the 11-item Chinese version of the Person-Centred Coordinated Care Experience Questionnaire (P3CEQ) before surgery. Secondary outcomes will include the change in Hospital Anxiety and Depression Scale (HADS) score from trial enrolment to before surgery, Quality of Recovery Score (QoR-15) on third day after surgery and Days Alive and At Home within 30 days after surgery (DAH30). Intention-to-treat and per-protocol analyses will be performed. ETHICS AND DISSEMINATION: The Joint CUHK-NTEC Clinical Research Ethics Committee approved the study protocol (CREC Ref. No. 2021.518-T). The findings will be presented at scientific meetings, in peer-reviewed journals and to study participants. TRIAL REGISTRATION NUMBER: ChiCTR2100053637.

Characterization of Patients With Obstructed Defecation and Slow Transit Constipation With a Simulated Stool.

INTRODUCTION: Defecatory disorders including obstructed defecation (OD) are currently diagnosed using specialized investigations including anorectal manometry and the balloon expulsion test. Recently, we developed a simulated stool named Fecobionics that provides a novel type of pressure measurements and analysis. The aim was to study OD phenotypes compared with slow transit constipation (STC) patients and normal subjects (NS). METHODS: Fecobionics expulsion parameters were assessed in an interventional study design. The Fecobionics device contained pressure sensors at the front, rear, and inside a bag. All constipation patients had colon transit study, defecography, anorectal manometry, and balloon expulsion test performed. The Fecobionics bag was distended in the rectum until desire-to-defecate in 26 OD compared with 8 STC patients and 10 NS. Rear-front pressures (preload-afterload parameters) and defecation indices (DIs) were compared between groups. RESULTS: The Wexner constipation scoring system score was 13.8 ± 0.9 and 14.6 ± 1.5 in the OD and STC patients (P > 0.5). The median desire-to-defecate volume was 80 (quartiles 56-80), 60 (54-80), and 45 (23-60) mL in OD, STC, and NS, respectively (P < 0.01). The median expulsion duration was 37 (quartiles 15-120), 6 (3-11), and 11 (8-11) seconds for the 3 groups (P < 0.03). Fecobionics rear-front pressure diagrams demonstrated clockwise loops with distinct phenotype differences between OD and the other groups. Most DIs differed between OD and the other groups, especially those based on the anal afterload reflecting the nature of OD constipation. Several OD subtypes were identified. DISCUSSION: Fecobionics obtained novel pressure phenotypes in OD patients. DIs showed pronounced differences between groups. Larger studies are needed on OD subtyping.