Wounds and Injuries

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Obesity

Postoperative Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Standard surgical closure of the fascia and skin.

Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

Standard Wound Closure

At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.

Prevena™ Incision Management System

Deanna G. Teoh, M.D.

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of \> 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients.

This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial

Masonic Cancer Center, University of Minnesota

Negative Pressure Wound Therapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Deanna GK Teoh

Negative Pressure Wound Therapy vs. Standard Wound Closure

Follow up data is not available for 2 participants

Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)

Only those participants who received adjuvant therapies were analyzed in both arms. Rest of the patients didn't have cancer that required subsequent therapies.

Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies

Overall Study

Digestive System Diseases

Rare Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Esophageal Cancer

Quality of Life

Patients allocated to usual care control will receive the standard patient care program as provided by the department of surgical gastroenterology, Rigshospitalet

Patients allocated to this group will receive usual care plus a supervised aerobic and resistance exercise program at CFAS' facilities consisting of 2 weekly sessions of approximately 60 minutes.

Supervised aerobic and resistance exercise program consisting of 2 weekly sessions of approximately 60 minutes. Patients will perform a test of maximum cardio-respiratory (Watt-max test) and muscle strength (1 repetition maximum \[1-RM\] test) capacity. Using the patient's individual capacity score (Watt-max and 1RM), a personalized exercise program will be prescribed. After a light warm-up, patients will perform 20-30 min of aerobic interval training of stationary bicycle. Resistance training comprises 4 exercises for the major muscle groups: chest press, leg press, lateral pull, and knee extension with 3-4 sets of 8 to 15 repetitions. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load.

Aerobic and Resistance Exercise Training

Jesper F Christensen, PhD

Background:

For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function, which are strong predictor of post-surgical complication and survival . A strong rationale exists to explore how to develop supportive interventions aimed at maintaining/improving muscle function (lean body mass and muscle strength) during the pre-surgical phase.

This study explores the safety, feasibility and efficacy of structured pre- and post-operative exercise training in patient undergoing surgery for cancer of the gastro-esophageal junction.

Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ scheduled for treatment af Rigshospitalet, Copenhagen, Denmark.

Methods: In a case-control design, patients will be allocated to either an exercise training intervention group, or a usual-care observational group, based on geographical location. Forty patients will be included in this case-control study and allocated by geographical region as follows; 20 training intervention-cases living in the greater Copenhagen area, and 20 observational control subjects living outside the greater Copenhagen area.

All patients will undergo a total of 5 assessments during the perioperative trajectory; twice prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and 15 weeks post-surgery, and at 1-year follow-up).

Assessments include measures of body composition by DXA scan and bioelectrical impedance analysis: systemic inflammation in fasting blood sample; quality of life by self-report questionnaires; physical function by handgrip strength and sit-to-stand test.

As optional procedures, we will collect biological tissue from tumor, muscle and fat biopsies and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will collect blood samples before, during and after an acute exercise bout exercise in order to explore the acute systemic changes in exercise-regulated biomarkers.

BACKGROUND AND RATIONALE Patients diagnosed with operable cancer in upper gastro-intestinal (GI) tract undergo serious therapeutic procedures including invasive surgery combined with chemo- or chemo-radio therapy before (neo-adjuvant) and/or after (adjuvant) surgery. Despite recent advances, especially in surgical techniques and patient care follow-up, the population is faced with one of the worst prognosis for patients with operable staged disease, with a 5-year relative survival of 35-40%. The only possibility of long-term survival is positive surgical outcome, which includes the surgical principle of performing wide clearance, achieving a negative margin (R0 resection), and performing a radical lymphadenectomy. To this end, considerable efforts have been made in recent years optimizing the perioperative period in order to provide the patients and the surgeons with the best possible chances of achieving this surgical outcome.

Adenocarcinoma of the gastro-esophageal junction (GEJ) has increased in incidence over the last quarter century. For patients presenting with localized disease, advances in standards of care have emerged in recent years which have improved disease management. Firstly, comprehensive staging with Computed Tomography (CT), endoscopic ultrasound, diagnostic laparoscopy and fluoro deoxy glucose position emission tomography (18FDG-PET) permits exclusion of patients for curative therapy who might previously have been scheduled for resection. Secondly, evidence supports that esophagectomy is performed in high-volume hospitals by high-volume surgeons. Finally, standard neoadjuvant and adjuvant therapies are performed in most centers for patients with localized esophageal adenocarcinoma which has improved both short- and long-term cancer outcomes.

Prognostic role of Muscle Function in upper GI cancer For all upper GI cancers, including GEJ, the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function. Over the last decade, strong observational evidence has emerged supporting that poor pre-surgical muscle function, defined as either low muscle mass/area (sarcopenia) or low functional strength, is a strong independent predictor of post-surgical outcomes including mortality, surgical complications and chemotherapy dose-reduction. Importantly, strong evidence across different malignancies has shown that the prognostic value of muscle function is independent from body mass, and may actually be under-reported due to sarcopenic obesity. Thus, current available therapeutic countermeasures in clinical practice, which exclusively involve nutritional interventions, may have limited potential for ameliorating the progressive muscle dysfunction during perioperative treatment for GEJ cancer.

Exercise-Oncology and Upper GI cancer Epidemiological evidence across both heterogeneous and homogeneous groups of cancer patients have shown that low physical activity level after diagnosis is associated with poor disease-specific and overall survival. Despite a general emerging interest, limited attention has been dedicated to the exploration of safety, feasibility and efficacy of structured exercise interventions in patients with upper GI cancer. However, data from recent studies suggests an unmet potential of physical exercise in these patients, with particular emphasis on the pre-surgical period.

STUDY OBJECTIVES Primary Objective

• To explore safety and feasibility of structured exercise in the pre- and post-operative phases among patients undergoing treatment for operable GEJ cancer

Secondary objectives:

* To explore the effect of perioperative exercise training on clinical (e.g. clindo-davien score, pneumonia, anastomotic leakage) physiological (e.g. muscle strength, physical function) and psycho-social (e.g. fatigue, emotional well-being, anxiety) endpoints relative to usual care.
* To explore the prognostic role of pathophysiological profile (physical function, pulmonary function, and body-composition) on post-surgical complications

Explorative objectives:

* To explore molecular adaptations of metabolism and physiology in tumor, muscle and fat samples taken before and after neo-adjuvant chemotherapy in the pre-operative phase in (a sub-group of) patients allocated to exercise training or usual care
* To explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session
* Collection of blood and tissue samples for storage in bio-bank for future research.

STUDY DESIGN This prospective, regional-based case-controlled feasibility trial will include in a minimum of 40 patients, including 20 training intervention-cases who are residents in greater Copenhagen Area, and 20 usual care controls living outside the greater Copenhagen area.

Recruitment: Patients will be recruited from the department of surgical gastroenterology, Rigshospitalet, following multidisciplinary medical conference. The responsible physicians will provide oral information and present patients with the written information of the study.

Patients who are willing to participate will sign informed consent, before any study related procedures are performed. After signing informed consent, patients are scheduled for baseline assessment and will be allocated based on geographical location (home-town municipality), to one of two experimental arms:

I) Patient residing OUTSIDE the Copenhagen area, will be allocated to a usual care observation group, which includes nurse-based follow up procedures and information on life style factors (diet, smoking cessation, alcohol, and physical activity).

II) Patients residing WITHIN the Copenhagen area, will be allocated to usual care plus hospital-based aerobic and resistance training at Centre for Physical Activity Research, Rigshospitalet

Procedures will involve assessment-measures conducted a total of 5 times during the study period: twice prior to surgery (baseline and pre-surgery test), twice post-surgery (3 week post- and 15 weeks post-surgery) and at 1-year follow-up.

The following assessments will be performed:

1. Body composition by Bioelectrical Impedance
2. Fasting blood sample for analyses of plasma biochemistry (cholesterol, triglycerides, inflammatory markers, HbA1C)
3. Health related Quality of Life questionnaires
4. Physical function: Handgrip strength and sit-to-stand test.
5. Forced Expiration Volume in 1 second (FEV1)
6. Biological tissue sampling (OPTIONAL): tumor, muscle and fat biopsies and blood samples - only baseline and pre-surgery.
7. Acute Exercise Response (OPTIONAL); blood samples taken before and after a single exercise session.

ANALYTIC PLAN As a feasibility study, this trial is explorative in nature and performed primarily in order to determine whether it is appropriate to advance with a larger scaled randomized controlled trial.

Primary aim

Safety and feasibility of perioperative exercise training in patients with operable GEJ cancer

In order to evaluate the safety and feasibility of the pre- and post-surgical exercise in patients with operable cancer of the gastro-esophageal junction, incidence of serious adverse events in both groups will be determined, and adherence to exercise, assessed by number of training sessions completed in the training group.

Secondary aims

Efficacy of perioperative exercise training to improve clinical, physiological and psycho-social outcomes in patients operable GEJ cancer.

In order to determine whether exercise training has the capacity to improve study outcomes intragroup changes, and inter-group differences for study outcomes will be calculated. For this purpose a random effect analysis will be performed with repeated measures and study outcomes as dependent variables, with the covariates "group", "time" and their interaction as fixed effects, and a random effect of "patient", adjusted for baseline-score, chemotherapy regimen, and surgical procedure (conventional vs laparoscopic).

Prognostic role of pathophysiological profile in patients with operable GEJ cancer

In order to explore the prognostic role of the study assessment outcomes on key clinical endpoints: post-surgical complications, hospital stay duration and disease free and overall mortality risk over the first years after surgery, by a general linear regression models with clinical endpoints being the dependent variable, and study assessment outcomes as the independent variables adjusted for baseline-score, chemotherapy regimen, and surgical procedure (conventional vs laparoscopic). For each variable (physical function, pulmonary function, and body-composition), the predictive value of: I) the diagnostic level (prior to neo-adjuvant therapy), II) the pre-surgical level (after neo-adjuvant treatment) and III) the change score from diagnostic to pre-surgical level (during neo-adjuvant therapy) will be determined.

Dropouts and Missing Observations Patients who wish to drop-out of the study during the intervention-periods will be offered to remain in the study with regard to test-assessments. Patients who drop out prior to 'visit 2' will be replaced. For between-group analyses, all drop-outs and missing observations will be handled by the "missing at random" principle.

ETHICAL CONSIDERATIONS This study will be conducted in accordance with the regional ethical committee and the Declaration of Helsinki (1964) with its subsequent revisions. The protocol and any substantial amendments, the study patient information and consent form, as well as other relevant or requested material have been approved by the local ethics committee (Videnskabsetisk Komite) for the Capital Region of Denmark (Protocol number: H-15014904) and is reported to the Danish Data Protection Agency (Datatilsynet: RH-2016-33, I-Suite nr.: 04396) through Rigshospitalet/Capital Region of Denmark (j.nr. 2012-58-0004).

The project is expected to cause limited risks, side effects and discomfort. All procedures will be performed by experienced physicians, therapists and physiologists with relevant safety, and patients will not experience any kind of delays or complications related to treatment or control process due to participation in the project. Patients may at any time, and without justification, retract their consent.

PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction

PeRioperative Study of Exercise Training - a None-randomized Feasibility Study: Usual Care Observation vs Exercise Training Intervention in Patients With Operable Cancer of the Gastroesophageal Junction

For the pre-surgical period (at baseline- and during surgery), we will ask for patients' separate consent to do a gastroscopy with sampling of a tumor biopsy; a muscle biopsy from m. vastus lateralis, fat biopsy from subcutaneous abdominal adipose tissue; and a blood sample, all of which will be collected during full anesthesia. A gastroscopy will be performed and endoluminal tumor biopsies will be collected under full anesthesia in patients who have given informed consent, after the diagnostic laparoscopy is completed. Muscle biopsies of approx. 200 mg per biopsy, will be collected from m. vastus lateralis using the Bergstrom-technique, and fat biopsies of approx. 200 mg per biopsy will be collected from the subcutaneous adipose tissue in the abdomen. Standard procedure requires the resection specimen to be dissected and cut open to determine lymph node classification and resection margins.

Recording of adverse events will be separated into two procedures: recordings during trial visits and recordings during exercise sessions.

AE/SAE recording during trial assessment visits This procedure will concern any AE/SAE which can be attributed to study-related assessment procedures during the trial visits, i.e. discomfort during physical tests or blood sampling, which will be recorded immediately during the visit and recorded for the given visit. Also, for each trial visit we will collect patients' self-report of AE/SAEs, which may have occurred during the period since the last trial visit without our knowledge.

AE/SAE recording during exercise sessions For every exercise session, a trained instructor will supervise the exercise program including recording of AE/SAEs during these session

Proportion of exercise sessions completed.

Body fat percentage is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Lean mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Body fat mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of LDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of HDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of triglyceride will be measured in fasting blood samples by standard laboratory methods.

HbA1C will be measured in fasting blood samples by standard laboratory methods.

Concentrations of TNFa will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-6 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-8 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-10 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Patient reported quality of life is measured by Functional Assessment of Cancer Treatment (FACT)

Patient reported sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI) questionaire

Patient reported Anxiety and Depression is measured by the Hospital Anxiety and Depression Scale (HADS).

Patient reported physical activity is measured by the Internations Physical Activity Questionaire (IPAQ) - short form

Sit-to-stand test: Lower-body physical function is assessed by 30-second sit-to-stand test. Using a chair fixed to the ground with a seat 45 cm above the ground subjects will be instructed to sit in the middle of the chair, back straight, arms crossed over their chest, feet flat on the floor. Correct technique will be demonstrated first, and subjects will practice for two-three repetitions. On the signal "go" subjects will be asked to stand then return to the seated position, as many times as possible in 30 seconds.

Handgrip strength is assessed by hand-held dynamometer. Grip strength is measured in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score.

FEV1 is evaluated by validated assessment measure of pulmonary function. The patient is instructed to make a complete inspiration and then inserts the mouthpiece into the mouth, closes the lips around it but with the jaws apart, and blows out through the mouth as hard and as completely as possible with strong verbal encouragement given throughout this sequence. The FEV1 score is the fraction of the total volume which is expired in the first second

Jesper Frank Christensen, PhD

Carcinoma

Urinary Bladder Neoplasms

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Other Dietary Supplements

Nicotine

Whey Protein

The intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke.

Patients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation.

Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire.

Prehabilitation

Martijn Stuiver, PhD

Emine Akdemir, MSc

Joost Boormans

Toine van der Heijden

Annemarie Leliveld

Anne M. May, Prof. dr.

Evert Koldewijn

Bart Bongers

Carl Wijburg

Siebe Bos

Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.

The ENHANCE study is a multicenter, randomized controlled trial. The intervention group will participate in a prehabilitation program of 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The prehabilitation program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. Patients will be asked to be physically active for an additional 2 times a week for at least 30 minutes. A dietician will provide nutritional support and give dietary advice to increase protein intake to enhance the anabolic effect on muscle mass. Additionally, patients will receive a supplement containing 30 g of high quality whey-protein daily preferably before sleep and after the supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychological support. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients in the intervention group will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. The physical activity level in both groups will be obtained via questionnaire.

EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy

EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial

Patients are asked informed consent for data sharing with POLARIS consortium

The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records

Time from admission until hospital discharge

Hospital readmission as recorded in medical file

Progression/recurrence, any additional treatment as recorded in medical file

Assessed via cardiopulmonary exercise test (CPET)

Short Physical Performance Battery (SPPB)

Short Form- Patient Generated Subjective Global Assessment (SF-PGSA)

Fat free mass and fat mass assessed by Scale Bioelectrical Impedance Analysis (BIA)

The total days as recorded in medical file

Identify clinical and sociodemographic variables that are related to non-participation of patients in this trial via questionnaire

To study the effectiveness of the prehabilitation program in terms of inducing favorable changes in tumor hypoxia markers

UMC Utrecht

University Medical Center Groningen

Radboud University Medical Center

Rijnstate Hospital

Noordwest Ziekenhuisgroep

Erasmus Medical Center

Maastricht University Medical Center

Karolinska Institutet

The Netherlands Cancer Institute

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Aspiration

Pain

Mindful Movement and Breathing program implemented in a hospital room or clinic room three times by a yoga instructor: prior to surgery, one day and two days after surgery.

Participate Mindful Movement and Breathing program with an experienced yoga instructor. All movements can be done while in a bed (e.g. turning head, shrugging shoulders, bending knees, etc). Each session lasts approximately 15 minutes.

Mindful Movement and Breathing program

Collected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery).

Questionnaire administration

Conducted by nurse and study coordinator prior to surgery and two days after surgery to assess mobility. Will ask patient to turn, sit, stand and walk as they are able.

The Observer Mobility Scale

Conducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used.

Volumetric Incentive Spirometry

Suzanne Danhauer, PhD

The purpose of this clinical trial is to understand if women undergoing surgery for a suspected gynecologic malignancy are interested in participating in a Mindful Movement and Breathing program and what the effects of this program are on women and the surgery-related symptoms they experience. Mindful Movement and Breathing programs may be effective for easing distress, post-surgical pain, and other symptoms of surgical procedures.

Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

The proportion of participants who participated in all YST sessions and those who completed all assessments will be computed and compared to those with incomplete data by demographic characteristics. We will model the relationship between adherence and baseline scores of the measures, as well as change in scores. We will also calculate the proportions and 95% confidence intervals of the items that measure program evaluation and intervention to the Clinical Studies Coordinator, nurses and yoga instructor.

Measured using Immediate Effect Visual Analog Scales (VAS) of pain and distress and percent change in inspiratory capacity as assessed with a Volumetric Incentive Spirometer. Assessed for each measure by day using a paired t-test and overall using a mixed effects model on the pre-post change in the measure over time.

means and standard deviations of the measures will be calculated to inform sample size calculations for a future study, and to provide descriptive statistics of the sample population.

Wake Forest University Health Sciences

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition

No immunonutrition, no glucose load, no early enteral immunonutrition

Preoperative 5 day oral Impact and early post-operative enteral Impact

Impact

Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery

Glucose load

Dan E Azagury, MD

The aim of this study is to demonstrate the influence of peri-operative nutrition on the post-operative complications, preservation of lean body mass and length of stay after gastrectomy or oesophagectomy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients	NCT02309944	Postoperative C... Obesity Gynecologic Neo...	Standard Wound ... Prevena™ Incisi...	18 Years -	Masonic Cancer Center, University of Minnesota
PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction	NCT02722785	Gastro-esophage...	Aerobic and Res...	18 Years - 80 Years	Rigshospitalet, Denmark
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients	NCT02309944	Postoperative C... Obesity Gynecologic Neo...	Standard Wound ... Prevena™ Incisi...	18 Years -	Masonic Cancer Center, University of Minnesota
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy	NCT05480735	Bladder Carcino...	Prehabilitation	18 Years -	The Netherlands Cancer Institute
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery	NCT01593657	Gynecologic Mal... Abdominal Surge... Pain Psychological D... Lung Function Surgical Compli...	Mindful Movemen... Questionnaire a... The Observer Mo... Volumetric Ince...	18 Years -	Wake Forest University Health Sciences
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery	NCT01593657	Gynecologic Mal... Abdominal Surge... Pain Psychological D... Lung Function Surgical Compli...	Mindful Movemen... Questionnaire a... The Observer Mo... Volumetric Ince...	18 Years -	Wake Forest University Health Sciences
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery	NCT00560846	Stomach Neoplas... Esophageal Neop...	Impact Glucose load	18 Years -	University Hospital, Geneva
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy	NCT05480735	Bladder Carcino...	Prehabilitation	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for surgical complications