Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Mastectomy

Breast-Conserving Surgery

Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Core management of breast cancer includes surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy (removal of the whole breast). Choosing between these two procedures may be influenced by factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the prevalence of BCS and mastectomy and the factors that may influence the choice of procedure. This retrospective study was carried out by reviewing the records of female breast cancer patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009 to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence. Using frequencies for the rate, and multivariate tests, the investigators analyzed different demographic, clinicopathological, and radiological factors to detect correlations with procedure choice.

Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients

Trends of Mastectomy and Breast-Conserving Surgery and Related Factors in Female Breast Cancer Patients Treated at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2009-2017

The percentage of of patients who underwent each surgery

Statistical analysis using independent sample T-test and binary logistic regression

Statistical analysis using Chi-square test and binary logistic regression

King Abdulaziz University

Professor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ttotal laparoscopic pancreaticoduodenectomy

Total laparoscopic pancreaticoduodenectomy

Open pancreaticoduodenectomy

Hang Zhang, M.D.

Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomized controlled trials (RCTs) are lacking but are clearly required.

Methods and analysis TJDBPS01 is a multicentre, prospective, randomized controlled, parallel-group, superiority trial in fourteen centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay (LOS).

Ethics and dissemination The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organization. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.

Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy(TJDBPS01) a Multicenter Randomized Controlled Trial

Length of stay was defined as the postoperative time interval in days

The amount of blood loss during surgical procedure.

Time between first incision and last skin closure.

Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.

Overall survival rate for 24 months after surgery

Shandong Provincial Hospital

The Second Hospital of Hebei Medical University

The Affiliated Hospital of Xuzhou Medical University

Xinqiao Hospital of Chongqing

Hunan Provincial People's Hospital

The First Hospital of Jilin University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

The Third Affiliated Hospital of Soochow University

Guangdong Provincial Hospital of Traditional Chinese Medicine

Afﬁliated Hospital of North Sichuan Medical College

First Affiliated Hospital of Chongqing Medical University

Peking Union Medical College Hospital

Henan Provincial People's Hospital

Sir Run Run Shaw Hospital

Fujian Medical University Union Hospital

Tongji Hospital

Clinical professor

Digestive System Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Obesity

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All successive patients meeting the including criteria and signed the informed consent will be measured BMI and the data will be recorded in the prospective database. The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). the normal range is usually considered to be 18.5 to 24.9, with less than 18.5 considered underweight, more than 25.0 considered overweight and above 30.0 obese. Investigators declare that there exists no conflicts of interest.

All successive patients meeting the including criteria and signed the informed consent will be measured BMI and the data will be recorded in the prospective database. The abdominal fat area at the umbilical level was measured using a CT scanner(sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice.The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit. No contrast agent is needed. Patients in the AFA group will be also measured by BMI. Investigators declare that there exists no conflicts of interest.

The abdominal fat area at the umbilical level was measured using a CT scanner(sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice.The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit . No contrast agent is needed.

AFA group (successive patients)

The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). the normal range is usually considered to be 18.5 to 24.9, with less than 18.5 considered underweight, more than 25.0 considered overweight and above 30.0 obese.

BMI group (successive patients)

Dong-Jiao Guo, M.D.

Xin-Zu Chen, M.D.Ph.D.

Xin-Zu Chen, MD.PH.D

Jian-Kun Hu, M.D.Ph.D.

As the number of obesity continues to increase, surgical oncologist pay more attention to the effect of obesity on surgical outcomes and survival of digestive systemin cancers. Body mass index(BMI) is one of the most widely used measurements of obesity. Abdominal fat area (AFA) calculated by computed tomography is popular because of its validity of fat distribution. There is still no consensus which of BMI and AFA could be the more effective measurement and more accurate to evaluate effect of obesity on surgical outcomes and survival. Gastric cancer is one of the most common digestive system cancers, and gastrectomy is the primary therapeutic options.It is important to compare the different measurements(BMI or AFA) to assess obesity and effect on surgical outcome and survival for gastric cancer patients.

Standard operation procedure（SOP）

1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. Procedures: The surgical treatments is adopted total or subtotal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3.
3. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
4. Follow-up: Follow-up will last to 5-year of the postoperative period. The postoperative complications is graded by the clavian-dildo classification. The postoperative complications and quality of life (change of AFA,performance status, recurrence and overall survival)are the focus of this study.

Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer

Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer Patients: a Single Center Prospective Cohort Study

The criteria of postoperative complications in the BMI group and AFA group both adopt the definition of The clavian-dildo classification of surgical complications: five-year experience. Ann Surg. 2009;250 (2):187-96.Postoperative complications in Grade 1 were classified as minor complications, while complications in Grade 2 to 5 were classified as major complications.

The body weight(kilograms) and height(meters) change of all enrollment after 5-year postoperative duration were measured to get the change of BMI.The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). The change of BMI was compared between preoperation and 5-year postoperative duration.

AFA of all enrollment after 5-year postoperative duration were measured by CT. The AFA at the umbilical level was measured using a CT scanner (sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice. The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit. The change of AFA was compared between preoperation and 5-year postoperative duration.

West China Hospital

Jian-Kun Hu

M.D. Ph.D.

Critical Illness

Disease Attributes

Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care)

Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold \& ventilatory equivalents

* AT \> 11ml/min/kg no myocardial ischaemia or Ve/VO2 \<35 - Level 1 Ward Care
* AT \> 11ml/min/kg with myocardial ischaemia or Ve/VO2 \>35 - Level 2/3 (ITU) Critical Care Unit
* AT \<11mls/min/kg - Level 2/3 Critical Care Unit
* AT \<8mls/min/kg - Level 2/3 Critical Care Unit/ consider cancellation or alternative procedure

Perioperative care pathway guided by CPX results

Michael PW Grocott

Paula Meale

Michael Mythen

Ayo Oshowo

Mervyn Singer

Geoff Bellingan

Kay Mitchell

Hasan Muktar

Alistair Windsor

Jim Down

Martin B Kuper

Denny ZH Levett

Phil Hennis, PhD

Alasdair O'Doherty, MSc

Alec Engledow

Aundrea Mulreany

Carolyn Dr Way

Karen Linford

Clare Bolger

Paul Nichols

Kim Golder

John S Knight

Michael Celinski

Grace Adesina

The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in guiding the care pathway of patients undergoing colorectal operations. In the intervention group care will be guided by CPX results and in the control group care will be guided by the doctors assessment. The investigators would like to assess the impact of this on patient outcome, patient satisfaction and resource usage.

Each year 20000 UK patients die within 30 days of surgery. It seems that in the UK a patient's chances of becoming seriously unwell or dying following surgery is higher than in comparable countries. Fewer beds in the UK are given over to Intensive Care than in these other countries. Closer attention to the care given after operations, which can be achieved on intensive care units (ICU), almost certainly reduces the chances of serious illness following major surgery. An increase in the number of intensive care unit beds in the UK is extremely unlikely. Better use of the available intensive care beds could be achieved by allocating them where they are believed to improve outcome (following surgery) and by allocating them to patients most likely to benefit.

Tests used to assess risk of surgery to patients are largely ineffective. Cardiopulmonary exercise tests (CPX) seem to be effective at identifying patients at risk of death or serious illness post surgery. This information has been used in studies to select patients for ICU beds and reduce deaths. The studies so far have limitations in their design and scope which means we can't be certain this approach works in the UK.

We suggest a study to answer this question more conclusively and more specifically in UK patients. We will randomly divide patients between two groups. In the 1st group choice of postoperative care environment is based on best current practice and in the other group we will make these decisions (critical care or ward) based on the results of the CPX.

We hope that the benefits will include less patients becoming seriously ill or dying and shorter stays in hospital after surgery following major operations. We also hope the information will help patients understand the risks of their operation better and therefore make better informed decisions. This may also reduce the overall cost of surgery for hospitals.

Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

A Randomised Controlled Trial of the Utility of Cardiopulmonary Exercise (CPX) Testing for Preoperative Risk Stratification to Guide Perioperative Care and Thereby Reduce Postoperative Morbidity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients	NCT03762642	Breast Cancer Breast Neoplasm... Breast Cancer F...	Mastectomy Breast-Conservi...	-	King Abdulaziz University
Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy	NCT03138213	Pancreatic Duct... Surgery Periampullary C...	Total laparosco... Open pancreatic...	-	Tongji Hospital
Effect of Obesity on Surgical Outcomes and Survival for Gastric Cancer	NCT02800005	Obesity Gastric Cancer	AFA group (succ... BMI group (succ...	18 Years - 75 Years	West China Hospital
Cardiopulmonary Exercise Testing and Preoperative Risk Stratification	NCT00737828	Colorectal Canc... Anaesthesia Critical Illnes...	Perioperative c...	18 Years -	University College London Hospitals
Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy	NCT03138213	Pancreatic Duct... Surgery Periampullary C...	Total laparosco... Open pancreatic...	-	Tongji Hospital

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