Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Antidiarrheals

Cola

Experimental: Intracorporeal anastomosis Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen is retrieved through a Pfannenstiel incision.

A transverse incision in the right upper quadrant is performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler

Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.

Device:

Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.

Intracorporeal anastomosis

A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler.

Device:

Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.

Extracorporeal anastomosis

Anna Sánchez López

Anna Sánchez López, Faculty

Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA).

However, there is currently no randomized studies describing long-term clinical and oncological outcomes.

Background:

Little evidence has been published demonstrating the advantages of IA versus EA.

Recent publications show the superiority of IA in terms of early functional digestive recovery, a shorter surgical incision, a lower need for analgesia, lower blood loss, and lower postoperative Clavien-Dindo grade. These results are similar to other further published studies, including multicenter randomized clinical trials and meta-analyses.

Methods:

This is a a long-term clinical follow-up study of 140 patients included preaviously in the single-blind single-center randomized prospective clinical trial conducted at the Hospital de la Santa Creu i Sant Pau (HSCSP) between 2015-2018; in which 30-day clinical outcomes after laparoscopic right colectomy for colon cancer with IA vs EA anastomosis were compared.

In this new trial, prospective clinical follow-up of the included 140 patients, randomized in two groups IA and EA, will be carried out, with a minimum time of 3 years.

The main objective of the study will be:

-Comparing long-term oncological outcomes of IA vs. EA anastomosis in laparoscopic right colectomy for malignant neoplasm.

The secondary objectives will be:

* Analyzing the appearance of abdominal wall hernias and episodes of occlusion.
* Describing the direct costs of both techniques retrospectively, through the financial records of the HSCSP institution.

The main hypothesis will be:

-IA is not inferior compared to EA in terms of oncological and clinical results, with a lower rate of abdominal postoperative hernias and occlusive/subocclusive episodes.

A regular prospective clinical follow-up through periodic medical visits and complementary tests established by the criteria of the Colorectal Cancer management protocol (document agreed by the HSCSP Colorectal Tumors Committee) will be conducted.

For the economic evaluation, all direct in-hospital costs that were registered by the HSCSP management will be analysed.

Extensive written information and an informed consent about the study will be provided to the patient.

The study does not entail any risk for the patient as it does not interfere with the usual follow-up or require extraordinary complementary studies.

The study was a parallel group trial with a 1:1 allocation ratio.

Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy

Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy

Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed

Percentage of patients alive without any type of recurrence (local or distant) after a 3-years follow-up-period since the laparoscopic right colectomy is performed

Percentage of patients that experiment disease recurrence which is placed in the previously operated area

Percentage of patients that experiment disease recurrence which is placed in a different area from the previously operated region (intraperitoneal, liver, lung metastases, etc)

Percentage of patients that present an abdominal hernia settled on any of the incisions performed during the laparoscopic right colectomy

Percentage of patients that experiment mechanical impairment or complete arrest of the passage of contents through the intestine due to pathology that causes blockage of the bowel.

Price (in euro) of the material used in the operating room in each procedure

Price (in euro) of the total amount of hours of surgical time per each procedure

Price (in euro) of the total amount of days of hospitalization per each group

Price (in euro) of the total amount of days of hospitalization in Intensive Care Unit per each group

Price (in euro) of the total amount of costs related to laboratory and diagnosis during the hospitalization period, per each group

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Sung Kyu Hong, M.D, Ph.D

Jae-kyung Oh, B.S.

The effect of preoperative glycemic control measured by HbA1c on renal cell carcinoma (RCC) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical or partial nephrectomy. The investigators will prospectively collect the relevant data including preoperative HbA1c in 238 patients of RCC patients undergoing nephrectomy. The associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple Cox-proportional hazards model, respectively.

* This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy.
* Particularly, the investigators check the variables, including age at surgery, body mass index, sex, comorbidities, preoperative HbA1c levels, blood urea nitrogen (BUN)/creatinine levels, estimated-GFR, clinical TMN staging by CT scan, final pathological results (TMN stage, histology, and Fuhrman nuclear grade), warm ischemic time and surgical margin status (in the case of partial nephrectomy), postoperative recurrence and distant metastasis, renal function changes during follow-up periods.
* The study protocol is same with routine follow-up schedule of the patients with RCC treated with nephrectomy. Typically, the investigators check the patients at 1, 3, 6, 12, 18, 24, 30 and 36 months. However, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. Because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes.
* Importantly, preoperative HbA1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.

Prognostic Significance of Preoperative Hemoglobin A1c (HbA1c) in Renal Cell Carcinoma

Prospective Cohort Study for the Impact of Preoperative Glycemic Control Status Measured by HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Renal Cell Carcinoma

Oncological outcome: recurrence-free survival

Seoul National University Hospital

Associate professor

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Nathan Lawrentschuk, MBBS,PhD, FRACS

Farleigh Reeves, MBBS, PhD

Damien Bolton

Lih-Ming Wong

Marlon Perara

Nathan Lawrentschuk

Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.

By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.

The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.

To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

The present study aims to model integration of clinical workflow data from Electronic Medical Records (EMR) to a research database using REDCap platform to enhance Prostate Cancer (PCa) research.

The objectives of the Victorian Robotic-assisted Radical Prostatectomy database are:

1. Collect functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline (pre-surgery), 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
2. Gather detailed insights into surgical measures in terms of demographics, operative and post-operative characteristics.

   1. Operative characteristics will include: Protein-Specific Antigen (PSA) at surgery, surgery Gleason score, International Society of Urological Pathologists (ISUP) grade group, pathological T score, scans at surgery, amount of blood loss, operation duration, type of anesthesia, survival status, mortality, surgical margins and pain score.
   2. Post-operative characteristics will include: length of hospital stay, duration of catheter use, complications (if any) and reasons of readmission (if any).
3. Collect the oncological measures in terms of biochemical recurrence and margin status.
4. Track the progress of surgeons learning curve by comparing the surgeons' training data with Patient Reported Outcome Measures (PROM).

Males who are diagnosed with localized Prostate cancer

National Robotics-Assisted Radical Prostatectomy Database

National Robotics Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcomes

* Patient data will only be transferred and analysed in a coded form by mentioned investigators.
* Transferring patient data will require host organisation's formal approval
* Individual patients will not be identifiable from the presented or published material.
* The institution and the researcher must comply with all relevant laws and standards in relation to the use of the material.
* The institution and researcher must not use the material for any purpose other than the specified research or other purposes expressly permitted under the terms of the Agreement.
* Data linkage across sites will be set up when necessary. Once linkage has been completed, identifiers will be removed from the data to be used in the research, unless consent has been given for its identifiable use.

Standardize notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

The first set of outcome variables will be the functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire

The second set of outcome variables will gather detailed insights into surgical measures in In terms of operative and post-operative characteristics.

The third set of outcome variables will collect the oncological measures in terms of Biochemical re-occurrence and margin status.

Peter MacCallum Cancer Centre, Australia

Epworth Healthcare

St Vincent's Hospital

Austin Health

Melbourne Health

Professor

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Pathologic Complete Response

Breast Diseases

Skin Diseases

Quality of Life

Patients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation

Single dose ablative radiotherapy

Yasmin Civil, MD

Desirée van den Bongard, MD, PhD

In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.

Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.

Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

pCR is defined as the absence of residual invasive cancer on resected breast specimen

Radiologic complete response (rCR) is defined as complete absence of pathologic contrast enhancement in the original tumor bed and complete absence of pathologic ADC (apparent diffusion coefficient) reduction in the original tumor bed. rCR is reported according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0

PROMs are assessed using the European Organization for Research and Treatment of Cancer core-30 quality of life questionnaire (EORTC QLQ-C30)

PROMs are assessed using the European Organization for Research and Treatment of Cancer breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23)

PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire

Cosmetic outcome is assessed by the physician using a questionnaire

Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. .

Cosmetic outcome is assessed objectively using images captured using the VECTRA XT 3D-imaging system. This three-dimensional surface-imaging system uses stereophotogrammetry to estimate x, y, z coordinates of the imaged surface. These coordinates will be used to calculate the volume-shape-symmetry measure.

A local recurrence is defined as disease occurrence in the ipsilateral breast. A regional recurrence is defined as nodal occurrence in the ipsilateral axilla, internal mammary, infraclavicular or supraclavicular region. A distant metastasis defined as disease occurrence in the contralateral breast or contralateral breast nodal region or another organ than breast involvement.

Overall survival will be calculated from the date of the radiotherapy treatment until the time of breast-cancer related death or breast-cancer unrelated death.

Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery.

ctDNA will be assessed in blood samples taken between radiotherapy and surgery.

Dutch Cancer Society

Amsterdam UMC, location VUmc

MD, PhD

The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).

The investigators will prospectively collect the relevant data including preoperative HbA1c in 264 patients of PCa patients undergoing RP. The associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple Cox-proportional hazards model, respectively.

* This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with prostate cancer (PCa) undergoing radical prostatectomy (RP).
* Particularly, the investigators check the variables, including age at surgery, body mass index, comorbidities, preoperative PSA levels, prostate volume measured by TRUS, preoperative HbA1c levels, biopsy Gleason score, positive biopsy cores, percent positive cores, clinical TMN staging, final pathological results (TMN stage, Gleason score, extraprostatic extension, seminal vesicle invasion, surgical margin positivity, postoperative biochemical recurrence (BCR), local recurrence, and distant metastasis during follow-up periods.
* The study protocol is same with routine follow-up schedule of the patients with PCa treated with RP. Typically, the investigators check the patients at 1, 3, 6, 9, 12, 18, 24, 30 and 36 months. However, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. Because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes.
* Importantly, preoperative HbA1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.

Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer

Prospective Cohort Study for the Impact of Preoperative Glycemic Control Status Measured by HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer

BCR was defined as either two consecutive increases in serum PSA (\>0.2 ng/mL) or the administration of adjuvant therapy during the postoperative follow-up period

Gleason scores of prostate cancer specimen described in final pathological report

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Patients are managed by radical gastrectomy with D1 lymphadenectomy

Patients are managed by radical gastrectomy with D2 lymphadenectomy

Radical gastrectomy with D1 lymphadenectomy

Radical gastrectomy with D2 lymphadenectomy

Mohamed Elmessiry, MD

Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.

This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.

D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Frequency of early postoperative complications

Frequency of early postoperative mortality

Frequency of tumor recurrence within 5 years after curative surgery

Frequency of Cancer specific mortality within 5 years after curative surgery

Percentage of patients survived for 5 years after surgery without tumor recurrence

Percentage of patients survived for 5 years after surgery with/without tumor recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy	NCT05446558	Colon Cancer Colon Neoplasm Malignant Neopl... Colon Neoplasia Colon Neoplasm,...	Intracorporeal ... Extracorporeal ...	18 Years -	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Prognostic Significance of Preoperative Hemoglobin A1c (HbA1c) in Renal Cell Carcinoma	NCT02417194	Carcinoma, Rena... Pathology Treatment Outco... Hemoglobin A1c ...		20 Years - 80 Years	Seoul National University Hospital
National Robotics-Assisted Radical Prostatectomy Database	NCT06279260	Database Prostate Cancer Robotic-assiste... Surgical Outcom... Oncological Out... Patient Reporte... Learning Curve		16 Years - 90 Years	Melbourne Health
Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy	NCT05446558	Colon Cancer Colon Neoplasm Malignant Neopl... Colon Neoplasia Colon Neoplasm,...	Intracorporeal ... Extracorporeal ...	18 Years -	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients	NCT05350722	Breast Cancer	Single dose abl...	50 Years -	Amsterdam UMC, location VUmc
Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer	NCT02436122	Prostate Neopla... Pathology		20 Years - 80 Years	Seoul National University Hospital
Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer	NCT02436122	Prostate Neopla... Pathology		20 Years - 80 Years	Seoul National University Hospital
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients	NCT05350722	Breast Cancer	Single dose abl...	50 Years -	Amsterdam UMC, location VUmc
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients	NCT05350722	Breast Cancer	Single dose abl...	50 Years -	Amsterdam UMC, location VUmc
D2 Versus D1 Gastrectomy of Operable Gastric Cancer	NCT04429841	Gastric Cancer	Radical gastrec... Radical gastrec...	20 Years - 80 Years	Alexandria University
Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer	NCT02436122	Prostate Neopla... Pathology		20 Years - 80 Years	Seoul National University Hospital

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