View clinical trials related to Ileus.
Filter by:The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
The investigators are testing the hypothesis that lower pressure pneumoperitoneum during laparoscopic large bowel surgery protects the bowel from postoperative ileus and bowel dysfunction leading to faster recovery and discharge from the hospital. Our study will focus on the effects of high or low intraperitoneal pressure as well as pressure variations on the course of postoperative ileus, time to hospital discharge, and postoperative gastrointestinal dysfunction in adult patients undergoing laparoscopic large bowel resection (i.e., sigmoidectomy and right colectomy). A randomized parallel group study will be conducted involving 5 arms of surgical patients to test whether differences on postoperative ileus outcome parameters occur between high (15 mm Hg) and low pressure pneumoperitoneum (8-12 mm Hg), as well as whether there are differences between the 2 insufflation devices that provide constant or variable intrabdominal pressure throughout the laparoscopic surgery. For high pressure pneumoperitoneum, either neostigmine or sugammadex are used for reversal of moderate neuromuscular blockade. For low pressure pneumoperitoneum, sugammadex is used for reversal of deep neuromuscular blockade. The investigators plan to use 2 types of gas insufflation devices, one of which will provide a relatively stable pressure level throughout surgery (AirSeal® device), and the second one will provide a more variable pressure (Olympus standard insufflation device). Using both pressure modalities, the investigators will study the effects of different pressure characteristics on the course of postoperative ileus, duration of in-hospital treatment, pain level, and the stability of hemodynamic and respiratory parameters during surgery. Changes in intrabdominal pressure during the surgery will be monitored and recorded using a custom software for later analysis of fluctuations in pressure to relate them to outcomes. Other parameters will be obtained from EPIC (IHIS) medical charts. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.
A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.
People who undergo surgery, or develop intestinal obstruction will spend a period of time without normal bowel function. This might extend beyond the normal measures of passage of flatus or tolerance of diet. This study will take a three stage approach to develop a patient reported outcome measure for gastrointestinal recovery. Stage 1: Qualitative interviews with 20-40 patients who have undergone major abdominal surgery, or conservatively managed intestinal obstruction. These interviews will identify key themes and ideas to develop the questionnaire. Stage 2: Face validity testing of questionnaire with 20 patients, using the QQ-10 questionnaire to aid assessment. The questionnaire may be edited after this. Stage 3: 250-500 patients will be asked to complete the questionnaire following surgery or treatment for intestinal obstruction. Basic demographics will also be collated. Item reduction and scale refinement will be undertaken using this dataset. This will provide a PROM of gastrointestinal recovery which is ready for validation.
The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage. I t is most often performed after a low anterior resection indicated for lower-middle rectal cancer. A second operation is required for closure, with a morbidity of about 25%. Many studies have been completed in order to detect possible risk factors - both patient-related and surgery-related - for complications in ileostomy closure surgery. Currently, there is a lack of research studies focused on the preoperative management of these patients. Our purpose is to reduce the complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus. Main objective: To assess whether efferent loop stimulation two weeks before ileostomy closure decreases the incidence of postoperative paralytic ileus.
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them. These pilot prospective, open clinical studies suggests that myoelectrical activity, measured on the abdominal surface with a noninvasive wireless patch system, carries predictive value in determining time to feeding and time to flatus following open abdominal surgery. Having such information in advance of clinical measures could facilitate timely interventions, be it early feeding or delaying feeding as dictated by the patient's unique recovery profile. The G-Tech Wireless Patch System would provide a unique insight into the process allowing for a tailored protocol that could improve patient satisfaction and optimize recovery. The system could also enable feedback on the impact to the overall gastrointestinal myoelectrical activity of medications, particularly opioids, used for pain management that are known to inhibit gastrointestinal function by disrupting the normal recovery patterns of colonic motility.23-25 While it remains to be seen, in addition to predicting time to flatus/bowel movement early on, the ability to continue monitoring the patient may allow one to predict onset of secondary complications, such as wound infections or anastomotic leaks, that are associated with ileus. Similarly, given the wireless noninvasive nature of the system the patients could be discharged home with the patches, whereby they would serve as a remote monitoring tool. This could be particularly useful in cases where the patients may have been discharged early and may be at a high risk for readmission. The system would then send updates/alerts to the care team for management and potentially avoid preventable readmissions.
Postoperative ileus (POI) is a serious complication after surgery. While it complicates all type of surgery, it is more frequent after abdominal surgery (especially bowel or colorectal surgery). Many studies aim to reduce the occurence of POI without efficiency. The aim of this study is to assess the efficiency of the vagal stimulation, by the mean of chewing, to reduce the duration of POI.
Postoperative ileus (POI) is a significant complication after colorectal surgery, with reported incidence ranging from 10~30%, leading to increased morbidity, hospital length of stay, and thus medical cost. To determine the risk factors for POI is one of the key elements for Enhanced Recovery after Surgery protocol. Increased perioperative opioid usage has been proposed as an independent risk factor for postoperative ileus, as perioperative opioid minimization has proposed to be an effective measure to decrease the incidence of POI. Although opioids are widely used to attenuate stress during surgery, and represent the cornerstone of pain treatment, anesthesiologists are strive to minimize opioid use to decrease opioid-related GI side effects. In this study, the investigators aim to find out the general occurrence of POI in the laparoscopic colorectal surgery and the effects of the postoperative opioid usage on this outcome. The strategies of opioid minimization was also investigated.
The goal of the BEET IT study is to examine if preoperative intake of beetroot juice can ameliorate gastrointestinal (GI) recovery after colorectal surgery and thereby help to reduce the duration of postoperative ileus (POI) and prevent prolonged POI. Adult patients undergoing laparoscopic colorectal surgery are randomized 1:1 to consume either concentrated beetroot juice (active intervention) or nitrate-depleted concentrated beetroot juice (placebo) during the week before their surgery. Blood, tissue and/or fecal samples are collected at specific time points pre- and/or postoperatively to study markers related to inflammation, oxidative stress and GI function. Patients are followed from the week before surgery (start of the intervention) until 3 months post-surgery. The study takes place at 5 hospitals in Flanders, Belgium.
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection.