Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Overweight

Breast Neoplasms

Obesity

Body Weight

Weight Loss

Breast Diseases

Skin Diseases

Overnutrition

Nutrition Disorders

Body Weight Changes

Individualized dietary counselling to reduce body weight

Individualized physical activity counseling to reduce body weight

Individualized dietary and physical activity counseling to reduce body weight

Materials and guidelines available to general public

Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

PADI

Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.

Patrick Maisonneuve

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial

weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

long-term weight control or maintenance via calibrated scales, stadiometer

change in total step count via pedometer device with electronic data transmission

change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire

change in dietary intake via Food Frequency Questionnaire

change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)

change in mood via State-Trait Anxiety Inventory (STAI) questionnaires

change in LDL, HDL, triglycerides and cholesterol assessed by blood samples

change in oestradiol assessed by blood samples

change in insulin assessed by blood samples

change in glucose assessed by blood samples

change in C-reactive protein assessed by blood samples

Associazione Italiana per la Ricerca sul Cancro

European Institute of Oncology

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Laparoscopic or robotic surgery with virtual ileostomy

Laparoscopic or robotic surgery with diverting ileostomy

fan li

fan li, PhD

This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the number of hospitalizations with ghost ileostomy versus conventional loop ileostomy after low anterior resection for rectal cancer.

Diverting ileostomy (DI) is a common procedure performed in patients undergoing low anterior resection for rectal cancer to protect the anastomosis and reduce the risk of complications. Although DI remains one of the most common methods used in clinical practice to prevent anastomotic leakage, there is still considerable debate in clinical practice about whether to perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly increased the risk of non-elective readmissions and reinterventions as well as higher total costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia, peristomal abscess, and fistula, etc.

Virtual Ileostomy Versus Diverting Ileostomy

Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Sphincter-saving Surgery for Rectal Cancer: a Propensity-matched Study

Hartmann's procedure or for example, abdominoperineal extirpation

Patients carrying stoma 6 months after low anterior resection for rectal cancer.

The virtual stoma required bedside or secondary surgery for diverting ileostomy due to complications.

Patients undergo second abdominal surgery for complications after low anterior resection for rectal cancer.

Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.

Abdominal abscess,Anastomotic bleeding,Pelvic infection,Surgical incision infection, Peritonitis,Interventional drainage ,ileostomy wounds/abscesses/edema/dermatitis/ ulcers,Parastomal hernia ,Stoma prolapse,Anastomotic separation/poor healing, Anastomotic stenosis,Anastomotic leakage,Bowel obstruction,Anastomotic bowel necrosis ,Wound dehiscence / bleeding / sinus tract / abscess/fat liquefaction,Acute kidney injury ,Dehydration/output \>1500 mL/day,Converted to permanent ileostomy,Intestinal fistula,Incisional hernia ,fecal incontinence.

Whether the patient has completed chemotherapy.

The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.

Patients in the virtual stoma group who did not have a second surgery due to complications recorded days of postoperative hospitalization after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record days of postoperative hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.

Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalization after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.

If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the duration of bearing the stoma since the data of surgery of diverting ileostomy.

Patient hospitalization costs for radical resection of rectal cancer.

Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the costs due to complications and reoperation since the data of low anterior resection for rectal cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology
Virtual Ileostomy Versus Diverting Ileostomy	NCT05985239	Rectal Cancer	VI DI	18 Years - 80 Years	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Virtual Ileostomy Versus Diverting Ileostomy	NCT05985239	Rectal Cancer	VI DI	18 Years - 80 Years	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Virtual Ileostomy Versus Diverting Ileostomy	NCT05985239	Rectal Cancer	VI DI	18 Years - 80 Years	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Spots Global Cancer Trial Database for di

Every month we try and update this database with for di 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 di

Every month we try and update this database with for di 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 di 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.