87 Clinical Trials for Various Conditions
Point-of-care gastric ultrasound will be used to measure stomach contents postoperative in patients who underwent colorectal surgery. Stomach volume and status (empty or full) will be compared retrospectively to the standard clinical criteria for diet advancement to determine if stomach volume via ultrasound is associated with successful diet advancement, nausea/vomiting, nasogastric tube replacement, length of stay, and other clinical outcomes. Clinicians performing clinical care will be blinded to the ultrasound exam results.
This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.
This study is designed as a prospective clinical trial aimed at investigating the mechanisms behind observed improvements in type 2 diabetes mellitus (T2DM) following bariatric surgery. The majority of patients with T2DM who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, in particular, experience complete remission of T2DM almost immediately post-surgery. This response occurs before significant weight loss is possible. To assess the mechanisms involved with disease resolution, the investigators propose a study to evaluate patients at the UW Medical Center (UWMC) who have T2DM and are undergoing RYGB with G (gastronomy)-tube placement as part of their clinical care. The investigators are interested in this sub-population as the G-tube allows us the unique opportunity to evaluate glycemic control and insulin response following delivery or exclusion of nutrients to the otherwise bypassed portion of the gastrointestinal tract. The investigators hypothesize that nutrient delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved in glucose control.
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.
A pilot to test feasibility of improving patient/caretaker quality of life and resilience.
The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.
This pilot study is looking at how well epoetin alfa, given in the immediate post-operative period, works in reducing anemia and the need for transfusions.
The institution of perioperative Enhanced Recovery Protocols (ERPs) has been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but data in pediatric populations are lacking. The Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery, which has the short title "ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US)," study is a multicenter, pragmatic, prospective study, using a stepped wedge cluster randomized controlled trial design. The study is designed to test the adoption, effectiveness, and generalizability of a newly developed, 21-element ERP for children undergoing elective gastrointestinal surgery.
This prospective randomized clinical trial will assess the effect of pre-operative convective warming on intra-operative thermoregulation in patients undergoing gastrointestinal or genitourinary surgical procedures with the Tiger anesthesia perioperative protocol.
The purpose is to identify modifiable factors in older adults associated with functional decline following major non-emergent surgery. The hypothesis of this proposal is that poor preoperative exercise tolerance and physical performance, potentially modifiable factors, are crucial in predicting functional decline and disability following surgery. When completed, this study will reveal detailed information on the incidence and risk factors for functional decline in older adults following surgery. It will direct future research targeting interventions in older adults at highest risk for functional decline following surgery, thereby decreasing the incidence of premature disability.
Observational research has linked physical activity with faster recovery, improved quality of life, and greater survival; however, little is known about the effects of physical activity in pre-operative, peri-operative, or post-operative treatment contexts and there is a need for interventions to improve patient outcomes across the cancer treatment continuum. Three propositions derived from basic research, epidemiological evidence, and clinical practice informed our intervention development efforts: (1) Patient outcomes will be enhanced by interventions that increase physical activity (i.e., standing, walking) across the cancer treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure) will enhance patient outcomes both by increasing physical activity and by stimulating additional adaptive physiological responses to reduced sedentary time (responses which are independent of physical activity-induced responses). (3) Patients with gastrointestinal cancers often suffer functional limitations that limit their independence and their health behaviors are strongly influenced by the family environment so interventions that engage caregivers (e.g., spouses) will be more effective than those that target patients/survivors alone.
Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic hypoglycemia (HH). The hypoglycemia is very debilitating and can be even life threatening. There is limited experience with pasireotide in hyperinsulinemic hypoglycemia (only one publication); there is more experience with octreotide, both in adults and children successful interventions with octreotide in hyperinsulinemic hypoglycemia have been published. Pasireotide via its different somatostatin receptor binding profile has clear effects on insulin, glucagon and incretin secretion and can ultimately lead to hyperglycemia. This mode of action (especially the effects on insulin and incretin secretion) could be very useful in the setting of hyperinsulinemic hypoglycemia.
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
This pilot clinical trial studies an electronic monitoring device of patient-reported outcomes (PROs) and function in improving patient-centered care in patients with gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way of asking patients about the quality of life, symptoms, and activity using online surveys and an activity tracking watch may make it easier for patients to tell their doctors and nurses about any issues before and after surgery. Electronic systems of assessing PROs may increase the depth and accuracy of available clinical data, save administrative time, prompt early intervention that improves the patient experience, foster patient-provider communication, improve patient safety, and enhance the consistency of data collection across multiple sites.
Infants with congenital gastrointestinal anomalies (CGIA) experience multiple physiologic stressors, including neonatal surgery, early in life during an essential time of growth and development. Early physiologic stressors such as inadequate nutrition have been linked to altered growth patterns and neurodevelopmental delays later in life. In other groups of at-risk infants, early body composition measurements can be used as predictors of long-term health outcomes more so than weight and length alone. The primary objective of this study is to determine if body composition changes in early life are predictive of neurodevelopmental outcomes among infants with CGIA. The secondary objective is to determine if infants with CGIA have altered body composition over time when compared with healthy infants. The investigators propose a prospective, observational study of infants with CGIA, including detailed chart review, body composition measurements, and neurodevelopmental testing at follow-up. If a correlation between body composition measurements and neurodevelopmental outcomes is established in this population, the addition of body composition measurement to standard of care in the neonatal intensive care unit and in follow-up care could allow for further optimization of overall health and development of this vulnerable pediatric population through earlier detection of growth alterations and informed interventions.
This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. Patients in the control arm will take 100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary objective is to determine the time to first bowel movement after surgery.
By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.
This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.
Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS. The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.
Objective: To follow people with GISTs and collect tumor tissue so that it can be studied in the lab. Eligibility: People age 6 and older who have a GIST. Design: Participants will be screened with a review of their medical records and samples. Participants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies. Participants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained. Participants may speak with a genetic counselor. They may have genetic testing. Participants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek. Participants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis. Participants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery. If a participant has surgery, tumor tissue samples and research specimen will be taken. If a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.
The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery. Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.
The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.
This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs
This phase III trial compares a home-based telemonitoring program that collects symptom and daily step information to surgeon only care in improving recovery and stopping complications within 30 days after surgery in patients with gastrointestinal, genitourinary, or gynecologic cancer who are scheduled to undergo abdominal surgery. Patients may experience a decrease in functional capacity and experience symptoms like pain and fatigue after surgery, and this may change their ability to walk and function. Home-based telemonitoring of patient symptoms and their ability to walk and function after surgery may help doctors and nurses find and treat problems early, which may improve the patient's recovery and lower the number of complications after surgery.
This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.
This pilot clinical trial studies how well Walking for Recovery from Surgery works in improving quality of life in older adults with lung or gastrointestinal cancer and their family caregivers. A walking program, such as Walking for Recovery from Surgery may help support overall well-being as a caregiver, and may help improve family member or friend's recovery from surgery.
The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques. It is hypothesized that the use of the Enseal device will demonstrate an improvement a patient's overall experience through less postoperative bleeding and pain, decreased time for wound healing, and a faster return to work.
This is a research study to evaluate the effectiveness of 3 different types of routine pain management regimens used during clinically indicated, minimally invasive oncologic (cancer) surgery. This project is considered "Research" and participation is voluntary. Upon enrollment in this study, the research team will collect data from the patient's medical records. The patient will undergo all of the normal testing and procedures required pre-operatively (standard of care). The study team will then randomly assign the patient (like a flip of a coin) to one of three different study arms for pain management during surgery: 1. Laparoscopic Transversus Abdominis Plane Block (LapTAP) with Local Anesthetic (LA) 2. Laparoscopic Transversus Abdominis Plane Block (LapTAP) only 3. Local Anesthetic (LA) only The patient will receive standard pre- and post-operative care according to clinical guidelines (routine care). The study team will collect information from the patient's medical record for the first 24 hours after their surgery and upon discharge. This information will include pain scores, amount of medication required, any side effects the patient may have experienced, and satisfaction with pain control. Participation in the study will end upon discharge from the hospital.