Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Quality of Life

Patients undergoing immediate techniques for oncoplastic surgery (level I only parenchmyl rotation and breast undermining as well as level II using complex reduction plastics for nipple-areola-complex movings) and patients with mastectomy and immediate reconstruction

patients undergoing conservative breast surgery

breast conserving surgery AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps

Breast Surgery

Breast conserving therapy without defect correction

Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.

Prospective Non-randomized Evaluation of Oncoplastic Surgery

Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer

self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.

Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery

Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery

local, distent and overal survival 2 as well as 5 years after surgery will be assessed

Medical University of Vienna

Professor of Surgery

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

The CME group consisted of patients, who underwent elective CME for right-sided colon adenocarcinoma at Nordsjaellands Hospital Hillerød from 1 June 2008 to 31 December 2013.

The non-CME group comprised patients having a elective conventional colon cancer resection for right-sided adenocarcinoma at the other three colorectal centers in the Capital Region of Denmark from 1 June 2008 to 31 December 2013.

The resection was based on the principles of CME. The superior mesenteric vein was exposed to perform central vessel ligation and lymph nodes dissection. Extended right hemicolectomies for tumors located from the ascending colon close to the hepatic flexure and distally were performed openly as standard during the study period. These resections included the prepyloric and gastroepiploic lymph nodes dissection.

Complete mesocolic excision

The patients underwent what was considered standard colon cancer resections in Denmark during the study period.

Conventional colon resections

Claus A Bertelsen, PhD, MD

Study based on existing databases investigating the causal oncological treatment effects of complete mesocolic excision on UICC stage I-III right-sided colon cancer.

Population-based cohort study, predominantly prospective based, on the same population as the investigator's previously study comparing short-term outcome after CME with conventional colon resections. The COMES database combines the prospectively registered colon cancer database in Hillerød (CME data), and data from the national database of the Danish Colorectal Cancer Group (DCCG) covering patients undergoing conventional resection (non-CME) in the other three centers. The medical records of all the patients in the non-CME group (control group) were reviewed by colorectal surgeons from Hillerød. Data audit for all CME patients was performed by various co-authors employed at the other centers. A similar audit of data for non-CME patients having postoperative complications or recurrence was performed by the co-author representing the department treating the specific patients.

Statistical analysis plan

Continuous data are presented as median and interquartile ranges, and categorical data as frequencies and proportions. Kruskal-Wallis test and Fisher's exact test were used as appropriate. Death is a competing risk to recurrence and time-to-event analyses were performed as competing risk analyses obtaining the cumulative incidences for recurrence or death using the "cmprsk" R-package.

Unbiased estimation of marginal or population-averaged treatment effects in observational and non-randomized studies can be obtained through different propensity score methods. Inverse Probability of Treatment Weighting (IPTW) uses the propensity score to weight each patient's data based on the inverse probability of receiving the treatment actually received. IPTW gives unbiased estimates of average treatment effects in time-to-event analyses if no differences in observed baseline covariates exist between the treatment groups. To account for baseline differences between patients in the two groups, stabilized weights truncated at the 0.99 interval were calculated using the "IPW" R-package. The following baseline covariates will be used: age, sex, ASA score, neoadjuvant chemotherapy, tumor location, tumor morphology, perineural invasion, extramural venous invasion, tumor stage, and serosal invasion. All covariates used and UICC stage, two-way interactions, and squared terms of continuous covariates will be assessed for balance between the CME and the non-CME group after IPTW using the "cobalt" R-package. Absolute mean differences in mean (using standardized mean difference) and proportions (using raw mean difference) below 0.1, variance ratios between 0.5 and 2, and Kolmogorov-Smirnov tests equal or below 0.05 will be accepted. Graphical inspection of the distribution of covariates will be also performed.

The cause-specific hazards and overall survival will be analyzed using Cox regression. Binary outcomes will be analyzed using logistic regression. Lymph node yield will be analyzed using linear regression after logarithmic transformation. Number of metastatic lymph nodes will be analyzed using negative binominal regression. All analyses of primary and secondary outcomes will be performed after IPTW. The 95% confidence intervals for the estimates from the original Cox regression IPTW analyses will be constructed after 1000 bootstraps with replacement, and a robust sandwich estimator will be used for the logistic regression analyses in order to ensure correct variance estimation.

All available data will be used. Model assumptions will be checked. A p-value below or equal to 0.05 will be considered significant. All analyses will be performed using R statistical software, version 3.5.1 (R Foundation for Statistical Computing, Vienna, Austria).

Five Year Oncological Outcome After CME for Right-sided Colon Cancer

Five Year Oncological Outcome After Complete Mesocolic Excision for Right-sided Colon Cancer: a Population-based Cohort Study

Recurrence diagnosed by CT or positron emission tomography (PET)/CT of thorax and abdomen, chest radiograph and contrast-enhanced ultrasound of the liver, or laparotomy in case of suspicion of recurrence. Histological verification of radiological findings of metastases during follow-up is not needed if the local multidisciplinary team conference deemed the finding as a recurrence. Metachronous colon tumors diagnosed during follow-up are considered as recurrences only if located in the anastomosis and with the same morphology as the primary tumor.

Death from any cause within 30 and 90 days

Patients having surgical and non-surgical postoperative complications and with complications with Clavien-Dindo score of 3b or more

Median number and specimens with 22 or more lymph nodes detected

Bispebjerg Hospital

Hvidovre University Hospital

Herlev Hospital

Zealand University Hospital

Nordsjaellands Hospital

Consultant Colorectal Surgeon, Head of Research

Rectal Diseases

Procedure/Surgery: laparoscopic colectomy

open colectomy

laparoscopic colectomy

Seigo Kitano, MD, PhD,FACS

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)

Ministry of Health, Labour and Welfare, Japan

Haruhiko Fukuda

JCOG Data Center

Rectal Neoplasms

Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included.

TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.

TME+Lateral lymph node dissection.

Qian Liu, M.D

Zheng Liu, M.D

Qian Liu, M.D.

To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

Our study design is a multicenter, prospective, registry study.

We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.

The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 \~ 50.5 Gy are recommended.

The postoperative examination should be performed every three months in the first two years and every six months in the following three years.

Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)

The data are available from Qian Liu upon request.

The proportion of patients with positive lateral lymph node which was confirmed pathologically.

The proportion of patients with local recurrence after 3 years of surgery

The proportion of patients survived after 3 years of surgery

The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.

The early morbidity rate is defined as the event observed during operation and within 30 days after surgery

The duration of time between the start and the end of the surgery.

Complications occurring within 30 days after surgery, mainly urinary and sexual functions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Non-randomized Evaluation of Oncoplastic Surgery	NCT01396993	Breast Image Sc... Breast Symmetry... Quality of Life Morbidity Oncological Out...	Breast Surgery Breast Surgery	18 Years - 65 Years	Medical University of Vienna
Five Year Oncological Outcome After CME for Right-sided Colon Cancer	NCT03754075	Colonic Neoplas...	Complete mesoco... Conventional co...	18 Years -	Nordsjaellands Hospital
A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer	NCT00147134	Colorectal Canc...	open colectomy laparoscopic co...	20 Years - 75 Years	Japan Clinical Oncology Group
MRI-guided Lateral Lymph Node Dissection in Rectal Cancer	NCT04850027	Rectal Cancer	TME+Lateral lym...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Five Year Oncological Outcome After CME for Right-sided Colon Cancer	NCT03754075	Colonic Neoplas...	Complete mesoco... Conventional co...	18 Years -	Nordsjaellands Hospital

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