Symptoms and General Pathology

All Conditions

Infections

Nutritional and Metabolic Diseases

Digestive System Diseases

Inflammation

Communicable Diseases

Malnutrition

Sepsis

Ileus

Nutrition Disorders

Pharmaceutical Solutions

All Drugs and Chemicals

Herbal and Botanical

Soybean oil, phospholipid emulsion

Fat Emulsions, Intravenous

Parenteral Nutrition Solutions

Soy Bean

Olive

Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital

Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.

Intralipid

ClinOleic

Johane P Allard, MD, FRCPC

Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).

Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.

There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.

The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.

Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.

Length of stay in the hospital and ICU will be recorded. We will record how many days it took,since admission to the hospital, for the patient to be discharged. This is an expected average of 4 weeks of length of stay.

We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable. The expected average of hospital stay is 4 weeks.

We will measure weight before, at day 10 and after PN to calculate the BMI at this different points. The last day of PN is whenever the patient is taken off PN. This can vary considerably from patient to patient.

we will record the infections the patients develop during PN until one week after PN

We will measure hand grip strength at baseline (day0) and at day 10 of PN. This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength

is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support

we will record antibiotic days from the start of PN until one week after PN is discontinued

hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN

Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency

Johane Allard

Professor of Medicine, Director-Division of Gastroenterology

Neoplasms

Rare Diseases

Stomach Neoplasms

Intestinal Obstruction

Intestinal Diseases

Gastrointestinal Diseases

Stomach Cancer

The patients who were received acupuncture after gastric cancer surgery

The patients who were not received acupuncture after gastric cancer surgery

Acupuncture treatment after gastric cancer surgery during 5 postoperative days

acupuncture

Hyun-dong Chae, Professor

Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is being accepted in the West as a treatment option for managing POI and various functional gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who underwent gastric surgery for a later large-scale study.

Before surgery, patients were randomized (using simple randomization) to either acupuncture (A) group or non-acupuncture (NA) group. In both groups, sitz markers were inserted in duodenum or jejunum during surgery for detection of postoperative remnant sitz markers by Xray. In the A group, acupuncture treatment was given once daily for up to 5 consecutive days starting on postoperative day 1. The acupuncture points which were used were based on traditional Korean medicine. No acupuncture treatment was performed in the NA group.

Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)

Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study

Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 1.

Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 3.

Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 5.

Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 7.

Daegu Catholic University Medical Center

Doctor

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Analgesics

Central Nervous System Depressants

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Anti-Arrhythmia Agents

Channel Blockers

Anticonvulsants

Psychotropic Drugs

Oxycodone

Anesthetics

Acetaminophen

Ibuprofen

Dexamethasone

Lidocaine

Bupivacaine

Morphine

Hydromorphone

Dexamethasone acetate

Analgesics, Opioid

Ketorolac

Ketorolac Tromethamine

Celecoxib

Gabapentin

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Narcotics

* Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital
* Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol.
* Intraoperative: dexamethasone and epidural bupivacaine
* Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine
* Postoperative: hydromorphone PCA, ibuprofen, oxycodone

* Day or surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg)
* Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight
* Day of surgery postoperative: toradol, ibuprofen, tylenol
* Postoperative: ibuprofen, oxycodone, and hydromorphone prn

-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP

-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)

-Lidocaine infusion 1 mg/kg ideal body weight (IBW)

Premal H Thaker, M.D., MS

Lindsay Kuroki, M.D., MSCI

Lara Crock, M.D., Ph.D.

To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).

Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy

A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.

-Defined by bilious emesis requiring a change in diet to nothing-per-mouth (NPO) status or nasogastric tube placement (NGT) in the absence of other indications. Patients who had NGT placed prophylactically at the time of surgery were not considered to have an ileus unless an NGT was reinserted or they met the above criteria. Participants will be assigned a value of yes ileus or no ileus. The rate of post op ileus is defined as the observed number of yes ileus in each study arm divided by the total number of subjects in the study arm. Fisher's exact test will be used to compare non-paired nominal data.

-Length of stay will be determined by the dates of admission as recorded on EPIC (days).

-Postoperative hypotension will be defined as \<90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit.

-Patients will be asked on day of discharge if they were satisfied with their pain control during their hospitalization. They will be able to choose from the following: 0=satisfied, 1= somewhat satisfied, 2= neutral, 3=somewhat dissatisfied, 4=dissatisfied).

-Pain scores will be determined by the 0-10 numeric rating scale (NRS). 0=no pain and 10=the most pain.

-As determined by an NRS pain score ≥ 5

Washington University School of Medicine

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

This group will be given a pedometer following radical cystectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 1,000/day. POD 3-6: 2,000/day. POD 7-9: 3,000/day. POD 10-14: 4,000/day. POD 14-21: 5,000

This is the control group. Following radical cystectomy subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery.

Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.

Use of a pedometer following surgery

Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.

Standard of care

Basil Ferenczi, MD

Basil A Ferenczi, MD

John Corman, MD

This is a study to evaluate whether use of a pedometer following radical cystectomy decreases post-operative narcotic use and time to return of bowel function.

This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical cystectomy on rate of ileus, return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 21. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until post-operative day 21.

Use of Pedometer Following Radical Cystectomy

Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy

Morphine equivalents used following radical cystectomy.

Time begins day of surgery to day of discharge. Time in days

Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)

Time from induction to emergence of anesthesia in minutes

Virginia Mason Hospital/Medical Center

Benaroya Research Institute

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Anti-Infective Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

During the two weeks prior to the ileostomy closure procedure, daily stimulation of the efferent loop will be performed by irrigation with 500 ml of physiological saline or 500 ml of warm water, preferably bottled, associated with a nutritional thickener. The patient will be instructed by a stomatotherapy nurse. Stimulation will be performed up to the day before the intervention. Kegel exercises will be suggested.

Every surgeon will use his or her usual technique for all patients included in the study, regardless of the group assigned in the randomization.

All patients in both groups will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol.

Direct standard surgery. Every surgeon will use his or her usual technique for all patients included in the study, regardless of the group assigned in the randomization.

All patients in both groups will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol.

Daily stimulation of the efferent loop will be performed during the two weeks prior to the surgery.

Ileostomy stimulation

Jorge Arredondo

Irene Oliva

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 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%. Bowel obstruction is the most common complication following this procedure, with an incidence of up to 29%. There is also a risk of anastomotic leakage, observed in 2% of patients, with a reintervention rate approaching 10%. A recent meta-analysis reported up to 2% mortality after stoma reversal.

There are many structural changes in the mucosa of the small bowel after ileostomy formation, which may contribute to the observed morbidity. The distal end may be atrophied, with pathophysiological changes contributing to a reduction in absorptive function and motility.

CONTROVERSY 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.

THE NEED FOR SUCH A STUDY There is a high risk of complications following ileostomy reversal (as high as 20%), including bowel dysfunction, anastomotic leakage, bowel perforation and postoperative ileus. This increases the length of hospital stay and healthcare costs.

Our purpose is to reduce this complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus.

MAIN PURPOSE (OBJECTIVE/GOAL/ SUBJET/PURPOSE) To assess whether efferent loop stimulation two weeks before ileostomy closure decreases the incidence of postoperative paralytic ileus.

SECUNDARY/SIDE/MINOR To evaluate hospital stay and short- and long-term postoperative complications in both groups. To compare postoperative anal continence in both groups.

INCLUSION CRITERIA Patients over 18 years of age who undergo a scheduled protective ileostomy closure surgery, performed in rectal cancer surgery. All patients will follow a homogeneous protocol for testing the rectal anastomosis prior to closure, based on an opaque enema to rule out the presence of anastomotic leakage. Entry into the study does not affect the other surgical indications, in terms of time to ileostomy closure, type of operation or anaesthesia, or request for additional tests. Elective surgery. Patients who sign the informed consent document.

EXCLUSION CRITERIA Patients undergoing simultaneous abdominal procedures at the time of ileostomy closure. History of protective ileostomy for a pathology other than rectal cancer. History of surgery in the ileal region.

BACKGROUND DATA Age, sex, body mass index (calculated as weight in kilograms divided by height in metres squared), American Society of Anesthesiologists (ASA) status and primary diagnosis. Neoadjuvant RT, neoadjuvant QT, time since end of adjuvant chemotherapy. Comorbidities (hypertension, DM, dyslipidaemia, respiratory pathology, others). Complications of the primary tumour surgery. Baseline analytical parameters: proteins, creatinine, ions, Hb and leukocytes.

SURGICAL DATA Operative time (in minutes), presence of parasternal hernia, time from main surgery to ileostomy closure, mesh placement.

EFFERENT LOOP STIMULATION TECHNIQUE:

During the two weeks prior to the ileostomy closure procedure, daily stimulation of the efferent loop will be performed by irrigation with 500 ml of physiological saline or 500 ml of warm water, preferably bottled, associated with a nutritional thickener (Resource, Nestlé Health-science, 6.4g sachet). The patient will be instructed by a stomatotherapy nurse. Stimulation will be performed up to the day before the intervention. Kegel exercises will be suggested.

SURGICAL TECHNIQUE Every surgeon will use his or her usual technique, with a choice between options A and B, using the same technique for all patients included in the study, regardless of the group assigned in the randomization.

Option A. Mechanical closure:

Peri-ileostomy incision. Ileostomy closure technique: anti-peristaltic L-L anastomosis by linear stapler with triple stapling, with endo-stapler closure of the enterotomy and similar loading. Invagination of the staple line.

Option B. Manual closing Peri-ileostomy incision. Ileostomy closure technique: Manual closure of the enterotomy with monofilament or braided suture, using loose stitches or continuous suture, according to standard technique.

All patients will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol.

PRIMARY OUTCOMES Presence of paralytic ileus (defined as intolerance to oral food on or after the third postoperative day, in the absence of clinical or radiological signs of obstruction, requiring placement of a nasogastric tube or associated with two of the following: nausea/vomiting, abdominal distention and the absence of flatus).

ADDITIONAL, MINOR, SECONDARY OUTCOMES Secondary outcomes will include length of hospital stay, time to tolerate regular diet, time to first passage of flatus, time to first passage of stool, general morbidity \[including anastomotic leak, surgical site infection (superficial, deep, organ space), other complications: urinary tract infection, pneumonia, postoperative acute kidney injury, deep vein thrombosis, pulmonary embolism, small bowel obstruction, myocardial infarction, stroke, reoperation and "other". Mortality and diarrhoea. The severity of surgical complications will be classified according to the Clavien-Dindo scale. Grade of postoperative continence and incidence of anterior resection syndrome. Hospital readmission rate.

LONG-TERM OUTCOMES (6 MONTHS):

Readmission rate. Surgical re-intervention. Eventration.

THE STATISTICAL ANALYSIS A comparative analysis will be performed between the two groups according to prior stimulation of the efferent loop or not.

Categorical samples will be analyzed by means of contingency tables and Chi-square. Continuous variables will be examined by comparing means using Student's t-test and medians with the Mann-Whitney U test. Values of p \<0.05 will be considered statistically significant. The SPPS 15.0 Inc. Chicago IL. software was used for this purpose.

Sample size estimation: Assuming an alpha risk of 0.05 and a beta risk of 0.2, in a two-tailed test, it is estimated that 68 patients need to be included in each group to find a statistically significant difference in proportions. A ratio of 0.29 in the control group and 0.1 in the intervention group is considered. A loss of patients of 5% is assumed.

Randomization will be performed in a 1:1 ratio in each hospital using the Sealed Envelope simple randomization service program. The researcher will not know the assigned group at the time of offering the study to the patient.

ETHICAL APPROVAL The study will be pre-approved by the local Research Ethics Committee (IRB). Patients will be informed of the possibility of participation in the study by signing the informed consent before being included. The patient will be able to withdraw his/her consent at any time without this affecting the medical care he/she will receive.

The study will be performed in accordance with the Declaration of Helsinki.

FINANCIAL REPORT No financial compensation for participation in the study is foreseen for either the patient or the research team. This study has not received any financial support.

Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.

Presence of paralytic ileus (defined as intolerance to oral food on or after the third postoperative day, in the absence of clinical or radiological signs of obstruction, requiring placement of a nasogastric tube or associated with two of the following: nausea/vomiting, abdominal distention and the absence of flatus).

General morbidity \[including anastomotic leak, surgical site infection (superficial, deep, organ space), other complications: urinary tract infection, pneumonia, postoperative acute kidney injury, deep vein thrombosis, pulmonary embolism, small bowel obstruction, myocardial infarction, stroke, reoperation and "other".

Grade of postoperative continence and incidence of anterior resection syndrome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils	NCT01943409	Obstruction Cancer Ileus Malnutrition Surgery	Intralipid ClinOleic	18 Years -	University Health Network, Toronto
Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)	NCT02480361	Ileus	acupuncture	18 Years - 80 Years	Daegu Catholic University Medical Center
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy	NCT05017246	Cancer Debulkin... Enlarged Uterus Fibroid Uterus Adnexal Mass	Bupivacaine Morphine Lidocaine	18 Years -	Washington University School of Medicine
Use of Pedometer Following Radical Cystectomy	NCT04305730	Bladder Cancer Ileus Narcotic Use	Use of a pedome... Standard of car...	18 Years - 75 Years	Benaroya Research Institute
Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.	NCT05302557	Ileostomy - Sto... Ileus Rectal Cancer Surgical Compli...	Ileostomy stimu...	18 Years -	Universidad de León
Use of Pedometer Following Radical Cystectomy	NCT04305730	Bladder Cancer Ileus Narcotic Use	Use of a pedome... Standard of car...	18 Years - 75 Years	Benaroya Research Institute
Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)	NCT02480361	Ileus	acupuncture	18 Years - 80 Years	Daegu Catholic University Medical Center

Spots Global Cancer Trial Database for ileus

Every month we try and update this database with for ileus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ileus

Every month we try and update this database with for ileus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ileus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.