35 Clinical Trials for Various Conditions
The purpose of this study is to create a decision tool using ultrasound, patient history, and laboratory values to predict a diagnosis of complicated diverticulitis and whether the patient requires further imaging. The accuracy of the decision tool will be evaluated. This study will also assess the ability of ultrasound to diagnose complicated and simple diverticulitis, and the inter-provider reliability of ultrasound interpretation of diverticulitis
This is a randomized trial (n=75) of a Mediterranean style Food Pattern and versus standardized guidance on fiber intake for patients with diverticulitis to evaluate the feasibility of this dietary intervention including willingness to randomize and adherence to a Med-style dietary pattern. The investigators will employ state-of-the-art behavioral interventions in the form of electronic feedback to improve health-related behaviors and support dietary customization based on participants' budget, dietary preferences, and restrictions. The investigators will also examine plasma inflammatory biomarkers (interleukin-6, interleukin-10, and interleukin-1β) and fecal calprotectin at baseline, 6, and 12 months.
Fecal Microbiota Transplantation (FMT) is an established treatment for Clostridium difficile (C. diff) infection refractory to medical management. As C. diff infection usually arises due to significant disturbances in the gut microbiome, FMT is typically performed to restore a healthy microbiome among affected patients who have failed other treatments. Diverticulitis is a major, and often recurrent, source of morbidity in the U.S for which antibiotics and surgical resection constitute the only treatment options to date. Although alterations of the intestinal microbiome have also been shown among patients with diverticular disease, research on FMT in diverticulitis is sparse. The intended goal of this project is to determine the feasibility, effectiveness and safety of FMT in the treatment of uncomplicated diverticulitis, using clinical outcomes and microbiome analyses.
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm.
This study aims to describe current treatment practices in the US for managing acute uncomplicated diverticulitis. In addition, we will identify clinical factors associated with the decision to discharge versus hospitalize patients with uncomplicated diverticulitis with the goal of informing clinical decision-making and providing a foundation for diagnostic algorithms to guide clinical practice.
Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last decade, the use of elective colon resection has increased by more than 50%, and diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike have a difficult time deciding if surgery is the best choice to treat diverticulitis. The goal of the DEBUT study is to improve the understanding about how doctors and patients make decisions to have elective surgery for diverticulitis, and the global impact of diverticulitis on patients' lives.
Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups.
The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.
The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
The goal of this observational study is to learn if a new surgical technique, called the NICE procedure, is as safe as standard methods for treating benign left-sided colon and rectal diseases in adults. The main question it aims to answer is: Does the NICE procedure lead to similar or lower rates of surgical site infections (SSIs) within 30 days compared to traditional surgery? Researchers will gather information from hospitals across the country to evaluate how well this procedure works when performed by experienced surgeons in everyday clinical settings. Participants will: Have surgery using the NICE procedure, which uses a robotic platform and removes the specimen through a natural opening (the rectum). Be monitored for any infections or complications after surgery. Complete surveys to track their recovery, bowel function, and quality of life for up to 6 months. This study may help improve recovery, reduce pain, and lower infection risk in future colorectal surgeries.
The study aims to determine the effect of gum arabic on gut bacteria and GI function.
The purpose of this trial is to gather information on the postoperative recovery time and hospital length of stay experienced by patients having laparoscopic surgeries. This trial will also collect data on daily surgical pain and pain medication and how it relates to recovery after surgery. In addition, the investigators will collect data on the use of pain medication and laxatives in patients following laparoscopic large bowel resection.
The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.
The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.
This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with or without polyethylene glycol work in reducing infection in patients undergoing elective colorectal surgery. Polyethylene glycol, may draw water from the body into the colon, flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to give preoperative neomycin and metronidazole hydrochloride with or without polyethylene glycol in reducing surgical site infection after colorectal surgery.
Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis. 2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality. This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.
Being able to accurately monitor patient bodily fluid levels during and after surgery is very important, as there are a number of complications that can arise if a patient's fluid levels become unbalanced, such as swelling within or pressure on various bodily organ systems. There are several different ways that physicians can monitor a patient's fluid balance during and after surgery, such as measuring the amount of urine output or the use of central venous catheters which measure the pressure in the veins entering the heart. Most of these techniques are invasive since they require tubes to be inserted into the body. A potential alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA). Bioimpedance assessments work by using small electrical currents that can accurately predict both the water surrounding the outside of cells in the body, as well as the total amount of water in the entire body. Electrical bioimpedance assessments have been used to estimate patient swelling following surgery (edema), to measure the volume of blood the heart is pumping out, as well as to calculate body fat percentages. The goal of this study is to relate this technology to fluid shifts within the body that occur as a result of surgery, in particular, major intra-abdominal surgeries. By using bioimpedance during and after surgery, the investigators will compare the data collected with that calculated by using traditional measures of body fluid status, such as urine output and intraoperative blood loss. During the study, the bioimpedance monitors will not replace the standard bodily fluid monitors and will not interfere with their readings. Additionally, the electrical current produced by the bioimpedance monitors is too small for patients to feel and will not interfere with medical devices such as pacemakers.
The purpose of the study is to evaluate the effect of Exparel on pain control and patient outcome after colon resection. The investigators will evaluate the clinical course of the patients who receive exparel as compared to the patients who do not receive exparel. Exparel is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three days. A long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5 hour half-life.
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known diagnoses identified by medical doctors. Specifically, the investigators hypothesize that the organ system involving any of a series of known active diagnoses will be identified in the EPIC ClearView Response Scale report with the intention of providing potential triage capabilities.
Bowel removal is indicated for various types of colon and rectal disease, including colon cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others. Following removal of the diseased segment of bowel your surgeon will reconnect the two healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an extremely dangerous situation. The cause of leakage has many causes and is not well understood, but appears to be at least in part due to not having enough blood going to the bowel. There is currently no way to evaluate the blood supply to the bowel. The purpose of this study is to utilize a special camera to evaluate the blood supply of the bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing the occurrence of leaks
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.
A database has been established to track the outcomes of all cases performed in the University Hospitals Department of Surgery in an effort to improve quality of surgical performance and case management. Specifically, the purpose of the database will be used as a quality improvement tool for analyzing process and outcome measures and to accurately track cases performed by surgeons.
The purpose of this study is to assess if follow-up telephone calls after colorectal surgery affects a patient's satisfaction, the outcome of their surgery, and their quality of life. In addition, readmissions, complications and emergency room visits can be tracked via these telephone calls, ensuring optimal communication between patients and the surgical office.
The purpose of this study is to produce a user-friendly tool- in the form of a questionnaire - to accurately assess early quality of life in patients after abdominal colorectal surgery from the first day after surgery to 6 months after. The study will also compare this questionnaire to the other currently available assessment tools. Patients are invited to participate if they are undergoing abdominal colorectal surgery at University Hospitals of Cleveland.
The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.
This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score \< 10 and \> 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes. The most common reason for surgery is acute appendicitis followed by gallbladder disease. Despite the common incidence of non-obstetric surgery among pregnant women, little is known regarding fetal outcome and the impact of laparoscopic interventions versus traditional open procedures. Even less is known about the role of non-operative management of general surgical disease in the pregnant population. However, fetal outcome is not compromised by emergency general surgery condition interventions.