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 and anorectal manometry 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 anorectal manometry-balloon expulsion test. The 4 females/6 males subjects were aged 23 (range 20-48) years. 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) cmH2O 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.

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.

Delaying surgery for optimization after colonic stent bridging is safe for left-sided malignant large bowel obstruction: Result from 10-year experience and risks factor analysis.

AIM: To evaluate the operative and oncological results after colonic stent bridging for left-sided malignant large bowel intestinal obstruction and the risk factors for survival and recurrence after definitive surgery. METHODOLOGY: Consecutive patients who underwent colonic stenting for malignant left-sided colonic obstruction were included. Patients for palliative stenting or emergency surgery, patient with low rectal tumour or peritoneal metastasis were excluded. The primary outcome was overall survival. Secondary outcomes included stent success rate, stenting related complications, rate of stoma formation and long-term oncological outcome including recurrence rate and recurrence free survival rate. RESULTS: From June 2011 to June 2021, a total of 222 patients underwent colonic stenting. 112 patients were bridged to surgery after initial stenting, but 7 patients dropped out. Overall survival was 35 months (IQR = 17.75-75.25 months) in the early operation group, 30 months (IQR = 17.5-49.5 months) in the delayed surgery group HR 0.981 (95%CI 0.70-1.395, p = 0.907). Sensitivity analysis performed by excluding stent complications and emergency surgery yielded the same conclusion. Overall stenting complications rate was 17.1%. 11 patients (10.4%) required emergency surgery. CONCLUSION: There was no difference between early and delayed surgery groups (>4weeks) in the overall survival and recurrence in patients who had stent-bridge to surgery for malignant left colonic obstruction. It is safe to defer definitive surgery to optimize patients and allow better recovery from initial obstruction after colonic stenting before definitive surgery without adversely affecting the oncological outcomes.

Droplet nuclei are generated during colonoscopy and are decreased by the use of carbon dioxide and water immersion technique.

OBJECTIVES: The COVID-19 pandemic has raised concerns on whether colonoscopies (CS) carry a transmission risk. The aim was to determine whether CS are aerosol-generating procedures. METHODS: This was a prospective observational trial including all patients undergoing CS at the Prince of Wales Hospital from 1 June to 31 July 2020. Three particle counters were placed 10 cm from each patient's anus and near the mouth of endoscopists and nurses. The particle counter recorded the number of particles of size 0.3, 0.5, 0.7, 1, 5, and 10 µm. Patient demographics, seniority of endoscopists, use of CO2 and water immersion technique, and air particle count (particles/cubic foot, dCF) were recorded. Multilevel modeling was used to test all the hypotheses with a post-hoc analysis. RESULTS: A total of 117 patients were recruited. During CS, the level of 5 µm and 10 µm were significantly higher than the baseline period (P = 0.002). Procedures performed by trainees had a higher level of aerosols when compared to specialists (0.3 µm, P < 0.001; 0.5 µm and 0.7 µm, P < 0.001). The use of CO2 and water immersion techniques had significantly lower aerosols generated when compared to air (CO2 : 0.3, 0.5, and 0.7 µm: P < 0.001; water immersion: 0.3 µm: P = 0.048; 0.7 µm: P = 0.03). There were no significant increases in any particle sizes during the procedure at the endoscopists' and nurses' mouth. However, 8/117 (6.83%) particle count tracings showed a simultaneous surge of all particle sizes at the patient's anus and endoscopists' and nurses' level during rectal extubation. CONCLUSION: Colonoscopy generates droplet nuclei especially during rectal extubation. The use of CO2 and water immersion techniques may mitigate these risks.

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.

Personalized laparoscopic resection of colon cancer with the use of indocyanine green lymph node mapping: Technical and clinical outcomes.

INTRODUCTION: To describe the experience of utilization of real time indocyanide green (ICG) fluorescent imaging for mapping out drainage lymph node and hence personalized lymphadenectomy in colorectal resection. METHODS: Perioperative injection of ICG before or during colon cancer resection by either intraluminal submucosal injection or laparoscopic peritumoural injection. The drainage lymph nodes were mapped out, and hence lymphadenectomy was performed enbloc with the main tumor. The effectiveness of mapping of drainage lymphatics and the procedure performed were recorded. RESULTS: A total of 21 patients (M:F = 14: 7) had perioperative ICG injection to map out the drainage lymphatics. The overall success rate was 86%. Seven patients (33%) had endoscopic submucosal injection, while 14 patients (67%) had intraoperative peritumoural injection. Three patients who had endoscopic submucosal injection had ICG extravasation, and hence failed lymph node mapping. Four patients (19%) had a change in extent of resection according to the lymph node mapping results. CONCLUSIONS: Personalized oncological colorectal resection and lymphadenectomy can be performed with the aid of ICG technology. Laparoscopic subserosal ICG injection may be the preferred route, as it minimize extravasation and aids to identify drainage lymph nodes without prolonging minimally invasive surgery. Further studies are required to determine the best route, strength, and timing of ICG injection and concordance with pathology to tailor the extent of resection for individual patients.

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.

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.

Mechanophysiological analysis of anorectal function using simulated feces in human subjects.

INTRODUCTION: Defecation is a complex process that is difficult to study and analyze. OBJECTIVES: Here, we present new analytical tools to calculate frictional force and tension during expulsion of the Fecobionics simulated stool in human subjects. METHODS: The 12-cm-long Fecobionics device contained pressure sensors, motion processor units for measurement of orientation and bending, and impedance rings for measurement of cross-sectional areas. Eight normal subjects defecated Fecobionics. The bending angle of the device, frictional force between the device and the surrounding tissue, and the stretch tensions were calculated. RESULTS: The bending angle and pressures changed during expulsion with the maximum pressure recorded at the rear. The averaged circumferential tension, longitudinal tension and friction force in each subject were associated with the front-rear pressure difference (r > 0.7, p < 0.005). The peak circumferential tension, longitudinal tension, and friction force immediately before expulsion of the rear were significantly higher compared to when the front entered the anal canal (F = 164.7, p < 0.005; F = 152.1, p < 0.005; F = 71.4, p < 0.005; respectively.). CONCLUSION: This study shows that Fecobionics obtained reliable data under physiological conditions. Mechanical features such as frictional force and stretch tensions were assessable during Fecobionics expulsion.

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.

Novel Fecobionics Defecatory Function Testing.

INTRODUCTION: Defecation is a complex process that can be easily disturbed. Defecatory disorders may be diagnosed using specialized investigation, including anorectal manometry (ARM) and the balloon expulsion test (BET). Recently, we developed a simulated stool named Fecobionics that integrates several tests and assesses pressures, orientation, and bending during evacuation. The aim was to evaluate the feasibility and performance of Fecobionics for assessing defecatory physiology in normal subjects. METHODS: Physiological expulsion parameters were assessed in an interventional study design. The 10-cm-long Fecobionics probe contained pressure sensors at the front and rear and inside a bag and 2 motion processor units. The bag was distended in the rectum of 20 presumed normal subjects (15 female/5 male) until urge to defecate. ARM-BET was also performed. Three subjects used +2 minutes to evacuate BET, and 1 subject had a high fecal incontinence score. Therefore, the normal group consisted of 16 subjects (13 female/3 male aged 25-78 years). RESULTS: All subjects reported that Fecobionics evacuation was similar to normal defecation. Fecobionics expulsion pressure signatures demonstrated 5 phases, reflecting rectal pressure, anal relaxation, and anal passage. Preload-afterload loop diagrams demonstrated clockwise contraction cycles. The expulsion duration for BET and Fecobionics was 16 ± 2 and 23 ± 5 seconds (P > 0.2), respectively. The duration of the Fecobionics and BET expulsions was associated (P < 0.001). The change in bending of Fecobionics during defecation was 40 ± 3°. DISCUSSION: Fecobionics obtained reliable data under physiological conditions. Agreement was found for comparable variables between ARM-BET and Fecobionics but not for other variables. The study suggests that Fecobionics is safe and effective in evaluation of key defecatory parameters.

Robotic surgery for rectal cancer: A systematic review of current practice.

AIM: To give a comprehensive review of current literature on robotic rectal cancer surgery. METHODS: A systematic review of current literature via PubMed and Embase search engines was performed to identify relevant articles from january 2007 to november 2013. The keywords used were: "robotic surgery", "surgical robotics", "laparoscopic computer-assisted surgery", "colectomy" and "rectal resection". RESULTS: After the initial screen of 380 articles, 20 papers were selected for review. A total of 1062 patients (male 64.0%) with a mean age of 61.1 years and body mass index of 24.9 kg/m(2) were included in the review. Out of 1062 robotic-assisted operations, 831 (78.2%) anterior and low anterior resections, 132 (12.4%) intersphincteric resection with coloanal anastomosis, 98 (9.3%) abdominoperineal resections and 1 (0.1%) Hartmann's operation were included in the review. Robotic rectal surgery was associated with longer operative time but with comparable oncological results and anastomotic leak rate when compared with laparoscopic rectal surgery. CONCLUSION: Robotic colorectal surgery has continued to evolve to its current state with promising results; feasible surgical option with low conversion rate and comparable short-term oncological results. The challenges faced with robotic surgery are for more high quality studies to justify its cost.

How to set up and manage a trainee-led research collaborative.

BACKGROUND: Ensuring that doctors in training acquire sufficient knowledge, experience and understanding of medical research is a universal and longstanding issue which has been brought into sharper focus by the growth of evidence based medicine. All healthcare systems preparing doctors in training for practice have to balance the acquisition of specific clinical attitudes, knowledge and skills with the wider need to ensure doctors are equipped to remain professionally competent as medical science advances. Most professional medical bodies acknowledge that this requires trainee doctors to experience some form of research education, not only in order to carry out original research, but to acquire sufficient academic skills to become accomplished research consumers in order to remain informed throughout their professional practice. There are many barriers to accomplishing this ambitious aim. DISCUSSION: This article briefly explains why research collaboratives are necessary, describes how to establish a collaborative, and recommends how to run one. It is based on the experiences of the pioneering West Midlands Research Collaborative and draws on the wider literature about the organisation and delivery of high quality research projects. Practical examples of collaborative projects are given to illustrate the potential of this form of research organisation. SUMMARY: The new trainee-led research collaboratives provide a supportive framework for planning, ownership and delivery of high quality multicentre research. This ensures clinical relevance, increases the chances of research findings being translated into changes in practice and should lead to improved patient outcomes. Research collaboratives also enhance the research skills and extend the scientific horizons of doctors in training.

Systematic review and meta-analysis of the incidence of incisional hernia at the site of stoma closure.

BACKGROUND: The incidence of incisional hernias at the site of stoma closure is surprisingly unclear. A review of the current literature was undertaken to determine how commonly this complication may occur and to assess the quality of evidence available. METHODS: A systematic review was performed to identify studies reporting the incidence of incisional hernia after closure of an ileostomy or colostomy. Studies including children (<16 years old) and studies in which >10% of the total number were trauma patients were excluded. RESULTS: Thirty-four studies provided outcomes for 2,729 closed stomas. Median follow-up time was 36 months but was only described in seven studies. Closure of loop ileostomies was the most commonly performed procedure (48%). The overall reported hernia rate was 7%, but with a wide range among studies (0-48%). Most studies based their hernia rates on retrospective clinical findings only. A separate analysis of three studies that were specifically designed to assess for stoma site hernias found the clinical hernia rate to be 30% (28/93) and the combined clinical/radiological hernia rate to be 35% (33/93). From 11 studies reporting reoperation rates, 51% of patients who developed a hernia required a surgical repair (34/66). There was a lower risk of hernia following reversal of ileostomy versus colostomy (odds ratio 0.28, 95% confidence interval 0.12-0.65). CONCLUSIONS: One in three patients may develop a hernia after stoma closure, and around half of hernias that are detected require repair. Risk of hernia is greater after colostomy closure than after ileostomy closure. Clinical measures to reduce the development of these hernias warrant consideration.

Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial.

BACKGROUND: Surgical site infection (SSI) is a common complication following abdominal surgery. It is associated with considerable morbidity and mortality, and its management results in significant cost to health services within both primary and secondary care. Some surgeons believe that the use of a wound-edge protection device may reduce the incidence of SSI. Whilst there is some encouraging evidence showing that such devices may lead to a reduction in SSI, there are no controlled trials of sufficient size or quality to support their routine use. METHODS/DESIGN: 750 patients will be recruited from around 20 surgical units within the United Kingdom. Patients undergoing laparotomy through any major abdominal incision for any indication, elective or emergency, are eligible. Patients under the age of 18, those undergoing a laparoscopic assisted procedure or who have undergone laparotomy within the previous 3 months, and those who are unable to give informed consent will be excluded. Patients will be randomised (1:1 ratio) to the use of a wound-edge protection device or no wound-edge protection device during surgery. Follow up will consist of blinded clinical wound reviews at 5-7 days and 30-33 days postoperatively with a self-completed questionnaire covering the intervening period. Quality of life questionnaires will be completed prior to surgery and at the subsequent wound review points and information on resource usage will also be captured.The primary outcome measure is SSI within 30 days of surgery. Secondary outcomes include the impact of the degree of wound contamination, patient comorbidity, and operative characteristics on the efficacy of a wound-edge protection device in reducing SSI and whether the use of a wound-edge protection device has an effect on health-related quality of life or length of hospital stay and is cost-effective. DISCUSSION: Rossini is the first multicentre observer-blinded randomised controlled trial of sufficient size and quality to establish whether the use of a wound-edge protection device in adult patients undergoing abdominal surgery leads to a lower rate of SSI. The results of this study will be used to inform current surgical practice and may potentially benefit patients undergoing surgery in the future. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN: ISRCTN40402832.