Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Adenocarcinoma

Postoperative Complications

Anemia

Hematologic Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Micronutrients

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Iron

Hepcidins

All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment

1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study

Intravenous ferric carboxymaltose

Austin G Acheson, MD FRCS

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).

It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

Intravenous Iron: Measuring Response in Anemic Surgical Patients

An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron

To assess the safety and feasibility of the principle of administration of intravenous iron in a single dose, preoperative outpatient visit

To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase

To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients

To monitor changes in hepcidin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in Erythropoietin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in transferrin saturation levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in ferritin levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in C Reactive Protein levels over the course of the study, and review if this can predict response to intravenous iron therapy, or is associated with changes in hepcidin

Nottingham University Hospitals NHS Trust

Skin and Connective Tissue Diseases

Breast Neoplasms

Participants will use an app to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores daily for 2 weeks post-op \& weekly for another 4 weeks. Surgeons will use a wireless interface to access that data and monitor the patient's condition. Participants will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, followup-related financial costs, and telemedicine satisfaction at 2 \& 6 weeks post-op. They will attend prescribed follow-up appointments with their surgeon with the option to skip 1 or more follow-up appointments dependent on their recovery trajectory \& surgeon.

The conventional follow-up care group will keep to conventional follow-up schedules of all surgeons involved. They will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, and followup-related financial costs at 2 \& 6 weeks post-op and attend all scheduled follow up appointments.

The mobile app follow-up care is an application that can be loaded onto a smartphone. It allows the patient to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 6 weeks following surgery.

RecoverWell mobile app for follow-up care

Claire Temple-Oberle, MD MSc FRCSC

This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery After Surgery) protocols and postoperative followup via a smartphone app can offer 1) improved patient satisfaction, 2) virtual patient monitoring without an increase in postoperative emergency room visits, number and severity of postoperative complications, and readmissions, 3) decreased healthcare system costs, and 4) improved patient convenience and reduced patient financial costs. The study will be conducted among women having mastectomy, breast reconstruction, and gynecological oncology procedures. Half of the participants will be assigned to physician monitoring via a smartphone app and half will receive conventional care.

ERAS® (Enhanced Recovery After Surgery) protocols are evidence-based best practices bundled together to revolutionize pre-, intra-, and postoperative care resulting in better patient outcomes, increased patient postoperative satisfaction, and decreased healthcare costs. ERAS® protocols in breast reconstruction and gynecologic oncology have been developed by surgeons from the Tom Baker Cancer Centre and have the sanction of the international ERAS® Society for implementation globally.

As of 2015, the majority of Canadians owned a cell phone. Technological advances in these forms of communications have been shown to positively impact patient experience and reduce healthcare system burdens. Telemedicine delivered healthcare via smartphone apps now include platforms for encouraging healthy behaviors, monitoring chronic healthcare conditions, organizing personal healthcare records, and monitoring postsurgical wounds.

The proposed study would marry these two advances, ERAS® protocols and smartphone technology, to consider how the combination of these two approaches to postsurgical care might enhance patient satisfaction and convenience and minimize financial burden while providing high quality care and monitoring. Additionally, the combination of these approaches has the potential to benefit the healthcare system in a number of ways. By lessening surgery-related length of stay and reducing the number of postsurgical visits, an opportunity for cost-savings is evident. In addition, in a system that is troubled by long wait-times for some procedures, reducing lengths of stay and surgeons' postoperative clinical burden means more patients can be seen and treated in a timely fashion. This is a win-win for the healthcare system and patients. It provides structure for more efficiently caring for post-operative patients in a patient first manner that supports physicians, transforms care, and engages in responsible stewardship of healthcare resources according to the Foundational Strategies developed by Alberta Health Services.

The current study would assess the patient, physician, and healthcare system impact of combining ERAS® protocol-guided oncological surgery with postsurgical patient monitoring via a smartphone app that would lessen patients' postoperative burden when postoperative recovery is uneventful and would alert physicians earlier when things are not going well.

Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery

The PSQ-III is a validated questionnaire made up of several subscales and employing a "statement of opinion" response model of 5 response categories (strongly agree, agree, uncertain, disagree, strongly disagree). The subscales being employed in the current study include general satisfaction, communication with your doctor, time spent with doctor, financial aspects, and access/availability/convenience.

The Quality of Recovery 15 scale captures patient reported postoperative assessment of various dimensions of health including patient support, comfort, emotions, physical independence, and pain. Patients rate each of the 15 statements from 1 (never) to 10 (always).

The costs related to attending one or more surgical followup appointments will be tracked. Participants will maintain a log of all associated expenses.

The total number of contacts with the healthcare system postoperatively will be tracked.

All complications occurring within the study period will be tracked. This information will be gathered.

Select adverse events including diarrhea, constipation, fever, urinary frequency/urgency, vaginal bleeding, wound complications, and fatigue will be tracked.

The participating surgeons and study nurses will keep diaries of time spent on patient followup, including followup appointments, receiving and returning phone calls, and tame spent related to virtual monitoring via the smartphone app.

A telephone interview will be conducted with study surgeons and nursing staff at the end of the study to inquire into the impact on medical professionals conducting conventional versus virtual monitoring of postoperative patients.

Alberta Cancer Foundation

Alberta Health Services, Calgary

Professor, Departments of Surgery and Oncology

Pharmaceutical Solutions

Vasoconstrictor Agents

Cardiotonic Agents

Central Nervous System Depressants

Other Dietary Supplements

Norepinephrine

Dobutamine

Benzocaine

Tannic Acid

* A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought.
* The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%.
* When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, dobutamine will be initiated with increasing doses up to 20mcg/kg/min.
* The final step will be red blood transfusion to reach a hematocrit higher than 28%.
* If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg.

Goal-directed Resuscitation Therapy (GDT)

The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.

Standard protocol

Aline Müller, MD

Ludhmila Hajjar, MD, PhD

The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.

Goal-Directed Therapy in Cancer Surgery

Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study

Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.

To compare the number of days of ICU stay and hospital stay between groups.

To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.

Daily sequential organ failure assessment score within the first 7 days after randomization

To compare the incidence of cardiovascular complications between groups. Cardiovascular complications will be defined as myocardial ischemia, acute decompensated heart failure, mesenteric ischemia, pulmonary thromboembolism and peripheral vascular ischemia.

Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria

Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.

To compare the incidence of stroke between groups within 30 days after randomization.

To compare the incidence, between groups, of infectious complications defined as a new septic shock.

To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death

University of Sao Paulo

Principal Investigator

Mineral

Iron Supplement

A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.

Ferric carboxymaltose

(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Ferrous Sulphate

Austin G Acheson, MBBS MD FRCS

116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention).

It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is a multi-center, randomized, open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. Patients will be randomized to receive intravenous ferric carboxymaltose (treatment group) or oral ferrous sulphate (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles, patient quality of life scores, operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

The primary hypothesis to be tested is that intravenous iron will decrease transfusion rates. To detect a significant clinical difference in blood transfused consistent with previous published data (1 unit), 58 patients will be required in each arm of the study with 90% power (alpha 0.05).

Randomization will be performed independently to the trial team using a computer generated variable block randomization program.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy

To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.

Hematinic markers include ferritin, iron, transferrin, transferrin saturation, erythropoietin.

To review the use of hepcidin as a biomarker to predict response to therapy.

Iron transport proteins include DMT TFR1, Ferroportin, Ferritin. As acquired from examination of pathology tissue specimen excised.

Post-operative outcomes include morbidity, mortality, length of stay.

Quality of Life questionnaires will be used (SF-36\[short form 36\] and EQ-5D)

National Institute for Health Research, United Kingdom

Fatigue

Colonic Neoplasms

Herbal and Botanical

Cola

Patients undergoing laparoscopic colonic surgery are compared with a historical cohort of patients undergoing similar open colonic surgery (right hemicolectomy and sigmoid resections).

Laparoscopic colonic surgery

Martin B Jensen, MD, Ph.d.

Søren Laurberg, Professor

The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery.

This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery.

Patients are examined preoperatively and postoperative day 10 and 30.

Rehabilitation Following Laparoscopic Colonic Surgery

Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery

Aarhus University Hospital

Associate Professor, Institute of Public Health Aarhus

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

"subject mobile application" and "Investigator web portal" with no invasive action on the human body

The research devices in this study are classified into "subject mobile application" and "investigator web portal" with no invasive action on the human body

Rhexium Onco Nutrition

Han-Kwang Yang, PhD

The objective of this pilot study is to evaluate the feasibility and efficacy of Rhexium Onco Nutrition, HDT-202 for post-operative care in patients who have undergone gastrectomy.

1. A total of 4 visits will be performed.
2. At the screening visit,subject's written informed consent, assessing the inclusion/exclusion criteria and assigning enrollment numbers to eligible subjects, demographic information taking, medical history/medication history taking, vital signs measuring, physical examination, height and body weight measuring, instructing how to install/use the investigational device, and administering quality of life questionnaires.
3. During the treatment period, a total of 3 visits will be performed. To evaluate feasibility and efficacy, the following procedures will be carried out: vital signs measuring, physical examination, nutrition assessment/consultation, evaluation of feasibility for 'subjects', evaluation of feasibility for 'investigators', and adverse events (AEs)/concomitant medications checking and collecting.
4. During the treatment period, telephone monitoring is conducted depending on the compliance of subjects.

NuGa (Nutrition for Gastric Cancer Patients)

A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer

Incident rate of Adverse Events will be reported

compliance(%) will be measured to day of usage/total period\*100

weight and height will be combined to report BMI in kg/m\^2, compliance(%) will be measured to day of usage/total period\*100

Seoul National University Hospital

Professor

An initial cohort of consecutive patients admitted to the 15th floor of the hospital on a Monday or Tuesday will form the usual care control arm of the study. Once this cohort is completed, the Caring Canines program will start.

Once the standard of care cohort is completed, the Caring Canines program will start making visits on the 15th floor and a second cohort of consecutive patients admitted to M15 on a Monday or Tuesday will form the intervention (experimental) arm of the study.patients admitted to M15 on a Monday or Tuesday will form the intervention (experimental) arm of the study.

For the staff portion of this study a longitudinal pre and post intervention design will be used. Baseline staff assessments will occur prior to the Caring Canine program being implemented on the unit. The assessments include questions about compassion satisfaction and compassion fatigue as well as some open ended questions about your thoughts on the Caring Canines program. Post assessment will occur after the program has been active on the unit for at least 6 weeks. Only staff who work at least one Monday - Friday day shift each week will be eligible to participate.

standard post surgery care

The therapy dogs who visit at MSKCC. A visit by a therapy dog typically lasts about 10-15 minutes with the patient interacting with the therapy dog while the dog is supervised by the handler.

Caring Canine program

The baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions.

baseline and post assessment

Pamela Ginex, EdD, RN, OCN

The purpose of this study is to describe the effects of canine-assisted activity visits on patients and staff in a hospital setting. The Caring Canines program uses dogs who have been trained to be obedient, calm and comforting. It involves a visit by a volunteer (called the dog's handler) and the volunteer's dog that has been trained and tested to have a good personality and to follow commands. A visit typically lasts about 10-15 minutes with the patient interacting with the dog while the dog is supervised by the handler. Memorial Sloan Kettering currently has Caring Canine dogs visit patients but the investigators don't yet know the impact of these visits on patients and staff. The investigators would like to see how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense of well-being. Two groups of patients will take part in this study - the first group will receive standard post surgery care and will not receive a visit from the Caring Canines program and the second group will receive daily visits (Tuesday -Friday) from the Caring Canines program while they are on M15. The purpose of this study is to look at differences in well-being between patients who have the visits with the dogs and patients who do not.

Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit

Caring Canines: Outcomes From an Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit

The PHQ-4 is an ultra-brief self-report questionnaire that consists of a 2-item depression scale and a 2 item anxiety scale. Among the control and intervention groups to assess psychological effects of the program. Responses on the pain scale will assess physiological effects, and responses on the open-ended questions will identify patient-perceived benefits of the program

(Compassion Satisfaction score and Burnout score) to assess change in work satisfaction due to the program, and responses on the qualitative questions will address staff-perceived benefits of the program.

Memorial Sloan Kettering Cancer Center

Hemorrhage

Postoperative Hemorrhage

Seroma

Breast Diseases

Skin Diseases

Inflammation

Coagulants

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

tranexamic acid to be smeared on surgical wounds before closure

saline to be smeared on surgical wounds before closure

moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml

moisten the surgical wound surface with 20 ml placebo (0.9% saline)

saline

Petter Aadahl, MD PhD

Sverrir Olafsson

After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer.

After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.

The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy

The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study

Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery	NCT03456167	Breast Cancer Gynecologic Can...	RecoverWell mob...	18 Years -	Alberta Health Services, Calgary
Goal-Directed Therapy in Cancer Surgery	NCT01946269	Postoperative C...	Goal-directed R... Standard protoc...	18 Years - 80 Years	University of Sao Paulo
IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia	NCT01701310	Anemia Colorectal Neop...	Ferric carboxym... Ferrous Sulphat...	18 Years -	Nottingham University Hospitals NHS Trust
Rehabilitation Following Laparoscopic Colonic Surgery	NCT00938210	Colonic Cancer Postoperative C... Fatigue	Laparoscopic co...	-	Aarhus University Hospital
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust
NuGa (Nutrition for Gastric Cancer Patients)	NCT04800991	Gastric Cancer	Rhexium Onco Nu...	19 Years -	Seoul National University Hospital
Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit	NCT02363608	Postoperative C...	standard post s... Caring Canine p... baseline and po...	18 Years -	Memorial Sloan Kettering Cancer Center
Rehabilitation Following Laparoscopic Colonic Surgery	NCT00938210	Colonic Cancer Postoperative C... Fatigue	Laparoscopic co...	-	Aarhus University Hospital
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery	NCT03456167	Breast Cancer Gynecologic Can...	RecoverWell mob...	18 Years -	Alberta Health Services, Calgary
Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit	NCT02363608	Postoperative C...	standard post s... Caring Canine p... baseline and po...	18 Years -	Memorial Sloan Kettering Cancer Center
The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy	NCT02627560	Postoperative H... Breast Neoplasm... Seroma	Tranexamic Acid saline	18 Years -	St. Olavs Hospital

Spots Global Cancer Trial Database for postoperative care